AzTrials
AzTrials

Lung Cancer, Non-Small CellPhase 3NCT00480025

GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Non-Small Cell Lung Cancer

A Phase 3 study testing GSK1572932A Antigen-Specific Cancer Immunotherapeutic in people with Lung Cancer, Non-Small Cell, run by GlaxoSmithKline at 620 sites in 34 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this clinical trial is to demonstrate the benefit of the immunotherapeutic product GSK1572932A when given to patients with Non-Small Cell Lung Cancer, after removal of their tumor. A course of 13 injections will be administered over 27 months. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Non-Small Cell
What is being tested?
GSK1572932A Antigen-Specific Cancer Immunotherapeutic
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,278 participants
Where
620 sitesin 34 countries
Study dates
4 Oct 2007to 23 Sep 2014
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female patient with completely resected, pathologically proven stage IB, II or IIIA NSCLC.
  • Written informed consent for MAGE-A3 expression screening on tumor biopsy has been obtained from the patient prior to shipment of the sample for expression testing (before or just after surgical resection), and written informed consent for the complete study has been obtained prior to the performance of any other protocol-specific procedure.
  • Patient is ≥ 18 years of age at the time of signature of the first informed consent form.
  • The patient's tumor shows expression of MAGE-A3 gene
  • The surgical technique for resection of the patient's tumor is anatomical, involving at least a lobectomy or a sleeve lobectomy;
  • The mediastinal lymph node sampling is done according to study protocol guidelines;
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  • The patient is free of metastasis, as confirmed by a negative baseline computer tomogram (CT scan) of the chest, upper abdomen and CT scan or MRI of the brain.
  • Other examinations should be performed as clinically indicated. Note that if randomization is taking place within 8 weeks after surgery, brain CT scans or brain MRI performed up to 4 weeks before surgery do not have to be repeated.
  • ECOG performance status of 0, 1 or 2 at the time of randomization.
  • Adequate bone-marrow reserve, adequate renal function and adequate hepatic function as assessed by standard laboratory criteria, and defined as:
  • Absolute neutrophil count ≥ 1.0 x 10E9/L Platelet count ≥ 75 x 10E9/L Serum creatinine ≤ 1.5 times the Upper Limit of Normal (ULN)
  • ≤ 3.0 times the ULN if due to platinum adjuvant chemotherapy Total bilirubin ≤ 1.5 times the ULN Alanine transaminase (ALAT) ≤ 2.5 times the ULN
  • If the patient is female, she must be of non-childbearing potential, i.e. have a current tubal ligation, hysterectomy, ovariectomy or be post menopausal, or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to administration of study treatment, have a negative pregnancy test and continue such precautions during all study treatment period and for 2 months after completion of the injection series.
  • In the view of the investigator, the patient can and will comply with the requirements of the protocol.

Who cannot join

  • The primary tumor was removed by segmentectomy or wedge resection.
  • The patient shows any evidence of residual tumor after surgery.
  • The patient has received any anti-cancer specific treatment, including radiotherapy, immunotherapy, chemotherapy or neo-adjuvant chemotherapy, except:
  • For the treatment of previous malignancies as allowed by the protocol (i.e., non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years), Administration of adjuvant platinum-based chemotherapy for the treatment of the current NSCLC is allowed between surgery and randomization.
  • The patient has previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers or carcinoma in situ of the cervix or effectively treated malignancy that has been in remission for over 5 years and highly likely to have been cured.
  • History of allergic disease or reactions likely to be exacerbated by any component of the study investigational product.
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  • The patient has an autoimmune disease such as, but not limited to, multiple sclerosis, lupus, and inflammatory bowel disease. Patients with vitiligo are not excluded.
  • The patient requires concomitant treatment with systemic corticosteroids, or any other immunosuppressive agents.
  • Note: The use of prednisone, or equivalent, <0.5 mg/kg/day (absolute maximum 40 mg/day), or inhaled corticosteroids for COPD or topical steroids is permitted.
  • The patient has received a major organ allograft.
  • The patient is known to be HIV-positive.
  • The patient has an uncontrolled bleeding disorder.
  • The patient has uncontrolled congestive heart failure or hypertension, unstable heart disease (coronary artery disease or myocardial infarction) or uncontrolled arrhythmia at the time of enrolment.
  • The patient needs home oxygenation.
  • The patient has psychiatric or addictive disorders that may compromise his/her ability to give informed consent, or to comply with the trial procedures.
  • The patient has other concurrent severe medical problems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
  • The patient has received any investigational or non-registered medicinal product other than the study medication within the 30 days preceding the first dose of study medication, or plans to receive such a drug during the study period.
  • For female patients: the patient is pregnant or lactating.

Trial locations and contacts

620 sites in 34 countries.

620 sites in 34 countries

United States201 sites

  • GSK Investigational Site

    Akron, Ohio, 44304

  • GSK Investigational Site

    Alexandria, Louisiana, 71301

  • GSK Investigational Site

    Alpharetta, Georgia, 30005

  • GSK Investigational Site

    Amarillo, Texas, 79106

  • GSK Investigational Site

    Ann Arbor, Michigan, 48109

  • GSK Investigational Site

    Annapolis, Maryland, 21401

  • GSK Investigational Site

    Armonk, New York, 10504

  • GSK Investigational Site

    Ashland, Kentucky, 41101

  • GSK Investigational Site

    Athens, Georgia, 30607

  • GSK Investigational Site

    Atlanta, Georgia, 30318

  • GSK Investigational Site

    Atlanta, Georgia, 30322

  • GSK Investigational Site

    Atlanta, Georgia, 30342

  • GSK Investigational Site

    Augusta, Georgia, 30901

  • GSK Investigational Site

    Aurora, Colorado, 80045

  • GSK Investigational Site

    Bakersfield, California, 93309

  • GSK Investigational Site

    Baltimore, Maryland, 21201

  • GSK Investigational Site

    Baltimore, Maryland, 21204

  • GSK Investigational Site

    Baltimore, Maryland, 21215

  • GSK Investigational Site

    Baltimore, Maryland, 21237

  • GSK Investigational Site

    Bay City, Michigan, 48706

  • GSK Investigational Site

    Bend, Oregon, 97701

  • GSK Investigational Site

    Bethesda, Maryland, 20892-1201

  • GSK Investigational Site

    Bethlehem, Pennsylvania, 18015

  • GSK Investigational Site

    Beverly Hills, California, 90211

  • GSK Investigational Site

    Billings, Montana, 59102

  • GSK Investigational Site

    Birmingham, Alabama, 35294-3300

  • GSK Investigational Site

    Boca Raton, Florida, 33486

  • GSK Investigational Site

    Boston, Massachusetts, 02111

  • GSK Investigational Site

    Boston, Massachusetts, 02114

  • GSK Investigational Site

    Boston, Massachusetts, 02118

  • GSK Investigational Site

    Boynton Beach, Florida, 33435

  • GSK Investigational Site

    Buffalo, New York, 14263

  • GSK Investigational Site

    Burbank, California, 91505

  • GSK Investigational Site

    Canton, Ohio, 44710

  • GSK Investigational Site

    Chapel Hill, North Carolina, 27599-7065

  • GSK Investigational Site

    Charleston, South Carolina, 29414

  • GSK Investigational Site

    Charleston, South Carolina, 29425

  • GSK Investigational Site

    Charlotte, North Carolina, 28203

  • GSK Investigational Site

    Charlotte, North Carolina, 28204

  • GSK Investigational Site

    Chattanooga, Tennessee, 37421

  • GSK Investigational Site

    Chicago, Illinois, 60611

  • GSK Investigational Site

    Chicago, Illinois, 60612

  • GSK Investigational Site

    Chicago, Illinois, 60637

  • GSK Investigational Site

    Cincinnati, Ohio, 45242

  • GSK Investigational Site

    Cincinnati, Ohio, 45267

  • GSK Investigational Site

    Coeur d'Alene, Idaho, 83814

  • GSK Investigational Site

    Colorado Springs, Colorado, 80907

  • GSK Investigational Site

    Columbia, South Carolina, 29209

  • GSK Investigational Site

    Columbus, Ohio, 43210

  • GSK Investigational Site

    Cookeville, Tennessee, 38501

  • GSK Investigational Site

    Dallas, Texas, 75230

  • GSK Investigational Site

    Dallas, Texas, 75231

  • GSK Investigational Site

    Dallas, Texas, 75246

  • GSK Investigational Site

    Danbury, Connecticut, 06810

  • GSK Investigational Site

    Danville, Pennsylvania, 17822

  • GSK Investigational Site

    Dayton, Ohio, 45429

  • GSK Investigational Site

    Decatur, Illinois, 62526

  • GSK Investigational Site

    Deerfield Beach, Florida, 33064

  • GSK Investigational Site

    Detroit, Michigan, 48201

  • GSK Investigational Site

    Detroit, Michigan, 48202

  • GSK Investigational Site

    Duarte, California, 91010

  • GSK Investigational Site

    Durham, North Carolina, 27705

  • GSK Investigational Site

    Durham, North Carolina, 27710

  • GSK Investigational Site

    East Syracuse, New York, 13057

  • GSK Investigational Site

    Evanston, Illinois, 60201

  • GSK Investigational Site

    Evansville, Indiana, 47713

  • GSK Investigational Site

    Everett, Washington, 98201

  • GSK Investigational Site

    Fairfax, Virginia, 22031

  • GSK Investigational Site

    Fayetteville, Arkansas, 72703

  • GSK Investigational Site

    Flint, Michigan, 48503

  • GSK Investigational Site

    Flushing, New York, 11355

  • GSK Investigational Site

    Fort Lauderdale, Florida, 33316

  • GSK Investigational Site

    Fort Smith, Arkansas, 72917

  • GSK Investigational Site

    Fresno, California, 93720

  • GSK Investigational Site

    Grand Island, Nebraska, 68803

  • GSK Investigational Site

    Grand Rapids, Michigan, 49503

  • GSK Investigational Site

    Grapevine, Texas, 76051

  • GSK Investigational Site

    Greenbrae, California, 94904-2007

  • GSK Investigational Site

    Greenville, North Carolina, 27834

  • GSK Investigational Site

    Greenville, South Carolina, 29615

  • GSK Investigational Site

    Harvey, Illinois, 60426

  • GSK Investigational Site

    Hazard, Kentucky, 41701

  • GSK Investigational Site

    Henderson, Nevada, 89052

  • GSK Investigational Site

    Hollywood, Florida, 33021

  • GSK Investigational Site

    Honolulu, Hawaii, 96813

  • GSK Investigational Site

    Houston, Texas, 77030

  • GSK Investigational Site

    Houston, Texas, 77090

  • GSK Investigational Site

    Indianapolis, Indiana, 46260

  • GSK Investigational Site

    Indianapolis, Indiana

  • GSK Investigational Site

    Jacksonville, Florida, 32209

  • GSK Investigational Site

    Jonesboro, Arkansas, 72401

  • GSK Investigational Site

    Kansas City, Missouri, 64111

  • GSK Investigational Site

    Kansas City, Missouri, 64132

  • GSK Investigational Site

    Knoxville, Tennessee, 37905

  • GSK Investigational Site

    Knoxville, Tennessee, 37920

  • GSK Investigational Site

    La Jolla, California, 92093-0987

  • GSK Investigational Site

    La Jolla, California, 92093

  • GSK Investigational Site

    Lancaster, Pennsylvania, 17605

  • GSK Investigational Site

    Langhorne, Pennsylvania, 19047

  • GSK Investigational Site

    Lansing, Michigan, 48910

  • GSK Investigational Site

    Lapeer, Michigan, 48446

  • GSK Investigational Site

    Lebanon, New Hampshire, 03756

  • GSK Investigational Site

    Lexington, Kentucky, 40503

  • GSK Investigational Site

    Long Branch, New Jersey, 07740

  • GSK Investigational Site

    Los Angeles, California, 90095

  • GSK Investigational Site

    Louisville, Kentucky, 40245

  • GSK Investigational Site

    Macon, Georgia, 31201

  • GSK Investigational Site

    Madison, Wisconsin, 53792

  • GSK Investigational Site

    Marietta, Georgia, 30060

  • GSK Investigational Site

    Memphis, Tennessee, 38104

  • GSK Investigational Site

    Memphis, Tennessee, 38120

  • GSK Investigational Site

    Metairie, Louisiana, 70006

  • GSK Investigational Site

    Milwaukee, Wisconsin, 53226

  • GSK Investigational Site

    Mineola, New York, 11501

  • GSK Investigational Site

    Minneapolis, Minnesota, 55407-3799

  • GSK Investigational Site

    Minneapolis, Minnesota, 55455

  • GSK Investigational Site

    Mobile, Alabama, 36604

  • GSK Investigational Site

    Mobile, Alabama, 36608

  • GSK Investigational Site

    Montebello, California, 90640

  • GSK Investigational Site

    Munster, Indiana, 46321

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    New Albany, Indiana, 47150

  • GSK Investigational Site

    New York, New York, 10003

  • GSK Investigational Site

    New York, New York, 10011

  • GSK Investigational Site

    New York, New York, 10016

  • GSK Investigational Site

    New York, New York, 10019

  • GSK Investigational Site

    New York, New York, 10032

  • GSK Investigational Site

    New York, New York, 10065

  • GSK Investigational Site

    Newark, Delaware, 19713

  • GSK Investigational Site

    Ocala, Florida, 34474

  • GSK Investigational Site

    Ogden, Utah, 84403

  • GSK Investigational Site

    Omaha, Nebraska, 68114

  • GSK Investigational Site

    Orange, California, 92868

  • GSK Investigational Site

    Orlando, Florida, 32804

  • GSK Investigational Site

    Orlando, Florida, 32806

  • GSK Investigational Site

    Owensboro, Kentucky, 42303

  • GSK Investigational Site

    Palm Springs, California, 92262

  • GSK Investigational Site

    Palo Alto, California, 94304

  • GSK Investigational Site

    Paramus, New Jersey, 07652

  • GSK Investigational Site

    Park Ridge, Illinois, 60068

  • GSK Investigational Site

    Peoria, Illinois, 61615-7822

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19104

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19111

  • GSK Investigational Site

    Philadelphia, Pennsylvania, 19140

  • GSK Investigational Site

    Phoenix, Arizona, 85013

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15212

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15232

  • GSK Investigational Site

    Pleasant Hill, California, 94523

  • GSK Investigational Site

    Portland, Oregon, 97213

  • GSK Investigational Site

    Providence, Rhode Island, 02903

  • GSK Investigational Site

    Providence, Rhode Island, 02906

  • GSK Investigational Site

    Rancho Mirage, California, 92270

  • GSK Investigational Site

    Roanoke, Virginia, 24014

  • GSK Investigational Site

    Rochester, Minnesota, 55905

  • GSK Investigational Site

    Round Rock, Texas, 78665

  • GSK Investigational Site

    Sacramento, California, 95816

  • GSK Investigational Site

    Sacramento, California, 95817

  • GSK Investigational Site

    Saint Louis Park, Minnesota, 55416

  • GSK Investigational Site

    Saint Louis Park, Minnesota, 55426

  • GSK Investigational Site

    Salt Lake City, Utah, 84106

  • GSK Investigational Site

    San Diego, California, 92121

  • GSK Investigational Site

    San Diego, California, 92123

  • GSK Investigational Site

    San Francisco, California, 94107

  • GSK Investigational Site

    Santa Rosa, California, 95403-1757

  • GSK Investigational Site

    Savannah, Georgia, 31405

  • GSK Investigational Site

    Sayre, Pennsylvania, 18840

  • GSK Investigational Site

    Scottsdale, Arizona, 85258

  • GSK Investigational Site

    Scottsdale, Arizona, 85259

  • GSK Investigational Site

    Seattle, Washington, 98104

  • GSK Investigational Site

    Seattle, Washington, 98108

  • GSK Investigational Site

    Seattle, Washington, 98109

  • GSK Investigational Site

    Shreveport, Louisiana, 71101

  • GSK Investigational Site

    Silver Spring, Maryland, 20902

  • GSK Investigational Site

    Southfield, Michigan, 48075

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    Spokane, Washington, 99208

  • GSK Investigational Site

    Springfield, Illinois, 62794-9638

  • GSK Investigational Site

    Springfield, Missouri, 65804

  • GSK Investigational Site

    St Louis, Missouri, 63110

  • GSK Investigational Site

    Stanford, California, 94305

  • GSK Investigational Site

    Stuart, Florida, 34994

  • GSK Investigational Site

    Sumter, South Carolina, 29150

  • GSK Investigational Site

    Syracuse, New York, 13210

  • GSK Investigational Site

    Tacoma, Washington, 98405

  • GSK Investigational Site

    Tampa, Florida, 33606

  • GSK Investigational Site

    Torrington, Connecticut, 06790

  • GSK Investigational Site

    Towson, Maryland, 21204

  • GSK Investigational Site

    Tucson, Arizona, 85724

  • GSK Investigational Site

    Tulsa, Oklahoma, 74136

  • GSK Investigational Site

    Tyler, Texas, 75708-3154

  • GSK Investigational Site

    Vallejo, California, 94589

  • GSK Investigational Site

    Vancouver, Washington, 98664

  • GSK Investigational Site

    Washington D.C., District of Columbia, 20007

  • GSK Investigational Site

    Waterbury, Connecticut, 06708

  • GSK Investigational Site

    Waterloo, Iowa, 50701

  • GSK Investigational Site

    West Hollywood, California, 90048

  • GSK Investigational Site

    West Palm Beach, Florida, 33401

  • GSK Investigational Site

    Wilkes-Barre, Pennsylvania, 18702

  • GSK Investigational Site

    Willow Grove, Pennsylvania, 19090

  • GSK Investigational Site

    Worcester, Massachusetts, 01605

  • GSK Investigational Site

    Worcester, Massachusetts, 01608

Other trials in United States

Germany72 sites

  • GSK Investigational Site

    Augsburg, Bavaria, 86156

  • GSK Investigational Site

    Bad Berka, Thuringia, 99437

  • GSK Investigational Site

    Bayreuth, Bavaria, 95445

  • GSK Investigational Site

    Berlin, 10117

  • GSK Investigational Site

    Berlin, 12200

  • GSK Investigational Site

    Berlin, 12351

  • GSK Investigational Site

    Berlin, 13125

  • GSK Investigational Site

    Berlin, 13353

  • GSK Investigational Site

    Bielefeld, North Rhine-Westphalia, 33604

  • GSK Investigational Site

    Bielefeld, North Rhine-Westphalia, 33611

  • GSK Investigational Site

    Bochum, North Rhine-Westphalia, 44791

  • GSK Investigational Site

    Bonn, North Rhine-Westphalia, 53113

  • GSK Investigational Site

    Braunschweig, Lower Saxony, 38114

  • GSK Investigational Site

    Bremen, 28325

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 50931

  • GSK Investigational Site

    Cologne, North Rhine-Westphalia, 51109

  • GSK Investigational Site

    Darmstadt, Hesse, 64283

  • GSK Investigational Site

    Dresden, Saxony, 01307

  • GSK Investigational Site

    Ebensfeld, Bavaria, 96250

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45122

  • GSK Investigational Site

    Essen, North Rhine-Westphalia, 45136

  • GSK Investigational Site

    Frankfurt (Oder), Brandenburg, 15236

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60487

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60488

  • GSK Investigational Site

    Frankfurt am Main, Hesse, 60590

  • GSK Investigational Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • GSK Investigational Site

    Fulda, Hesse, 36043

  • GSK Investigational Site

    Gauting, Bavaria, 82131

  • GSK Investigational Site

    Greifswald, Mecklenburg-Vorpommern, 17487

  • GSK Investigational Site

    Großhansdorf, Schleswig-Holstein, 22927

  • GSK Investigational Site

    Halle, Saxony-Anhalt, 06114

  • GSK Investigational Site

    Halle, Saxony-Anhalt, 06120

  • GSK Investigational Site

    Hamburg, 20246

  • GSK Investigational Site

    Hamburg, 21075

  • GSK Investigational Site

    Hanover, Lower Saxony, 30625

  • GSK Investigational Site

    Heidelberg, Baden-Wurttemberg, 69126

  • GSK Investigational Site

    Hemer, North Rhine-Westphalia, 58675

  • GSK Investigational Site

    Herne, North Rhine-Westphalia, 44623

  • GSK Investigational Site

    Homburg, Saarland, 66421

  • GSK Investigational Site

    Immenhausen, Hesse, 34376

  • GSK Investigational Site

    Kiel, Schleswig-Holstein, 24105

  • GSK Investigational Site

    Koblenz, Rhineland-Palatinate, 56068

  • GSK Investigational Site

    Leipzig, Saxony, 04103

  • GSK Investigational Site

    Leipzig, Saxony, 04129

  • GSK Investigational Site

    Lübeck, Schleswig-Holstein, 23538

  • GSK Investigational Site

    Lüdenscheid, North Rhine-Westphalia, 58515

  • GSK Investigational Site

    Mainz, Rhineland-Palatinate, 55131

  • GSK Investigational Site

    Moers, North Rhine-Westphalia, 47441

  • GSK Investigational Site

    Mülheim, North Rhine-Westphalia, 45473

  • GSK Investigational Site

    Munich, Bavaria, 81925

  • GSK Investigational Site

    Münster, North Rhine-Westphalia, 48149

  • GSK Investigational Site

    Münster, North Rhine-Westphalia, 48153

  • GSK Investigational Site

    Neuss, North Rhine-Westphalia, 41464

  • GSK Investigational Site

    Oberhausen, North Rhine-Westphalia, 46145

  • GSK Investigational Site

    Offenbach, Hesse, 63069

  • GSK Investigational Site

    Oldenburg, Lower Saxony, 26121

  • GSK Investigational Site

    Ostercappeln, Lower Saxony, 49179

  • GSK Investigational Site

    Porta Westfalica, North Rhine-Westphalia, 32457

  • GSK Investigational Site

    Regensburg, Bavaria, 93049

  • GSK Investigational Site

    Regensburg, Bavaria, 93053

  • GSK Investigational Site

    Rosenheim, Bavaria, 83022

  • GSK Investigational Site

    Rostock, Mecklenburg-Vorpommern, 18057

  • GSK Investigational Site

    Trier, Rhineland-Palatinate, 54290

  • GSK Investigational Site

    Troisdorf, North Rhine-Westphalia, 53840

  • GSK Investigational Site

    Ulm, Baden-Wurttemberg, 89081

  • GSK Investigational Site

    Velbert, North Rhine-Westphalia, 42551

  • GSK Investigational Site

    Villingen-Schwenningen, Baden-Wurttemberg, 78050

  • GSK Investigational Site

    Waldbröl, North Rhine-Westphalia, 51545

  • GSK Investigational Site

    Wangen, Baden-Wurttemberg, 88239

  • GSK Investigational Site

    Weißenfels, Saxony-Anhalt, 06667

  • GSK Investigational Site

    Würzburg, Bavaria, 97070

  • GSK Investigational Site

    Zwickau, Saxony, 08058

Other trials in Germany

France42 sites

  • GSK Investigational Site

    Angers, 49933

  • GSK Investigational Site

    Bayonne, 64100

  • GSK Investigational Site

    Beauvais, 60021

  • GSK Investigational Site

    Béthune, 62408

  • GSK Investigational Site

    Bordeaux, 33000

  • GSK Investigational Site

    Brest, 29609

  • GSK Investigational Site

    Bron, 69677

  • GSK Investigational Site

    Caen, 14033

  • GSK Investigational Site

    Elbeuf, 76503

  • GSK Investigational Site

    Lille, 59000

  • GSK Investigational Site

    Lille, 59037

  • GSK Investigational Site

    Limoges, 87042

  • GSK Investigational Site

    Lorient, 56322

  • GSK Investigational Site

    Lyon, 69003

  • GSK Investigational Site

    Lyon, 69365

  • GSK Investigational Site

    Lyon, 69373

  • GSK Investigational Site

    Marseille, 13915

  • GSK Investigational Site

    Meaux, 77104

  • GSK Investigational Site

    Metz, 57038

  • GSK Investigational Site

    Montpellier, 34295

  • GSK Investigational Site

    Mulhouse, 68070

  • GSK Investigational Site

    Nantes, 44202

  • GSK Investigational Site

    Nice, 06002

  • GSK Investigational Site

    Nîmes, 30029

  • GSK Investigational Site

    Paris, 75014

  • GSK Investigational Site

    Paris, 75018

  • GSK Investigational Site

    Paris, 75020

  • GSK Investigational Site

    Paris, 75248

  • GSK Investigational Site

    Paris, 75970

  • GSK Investigational Site

    Périgueux, 24019

  • GSK Investigational Site

    Perpignan, 66000

  • GSK Investigational Site

    Reims, 51100

  • GSK Investigational Site

    Rennes, 35033

  • GSK Investigational Site

    Rouen, 76000

  • GSK Investigational Site

    Saint-Grégoire, 35768

  • GSK Investigational Site

    Saint-Herblain, 44805

  • GSK Investigational Site

    Saint-Priest-en-Jarez, 42271

  • GSK Investigational Site

    Saint-Quentin, 02321

  • GSK Investigational Site

    Toulon, 83041

  • GSK Investigational Site

    Toulouse, 31059

  • GSK Investigational Site

    Vannes, 56017

  • GSK Investigational Site

    Villefranche-sur-Saône, 69655

Other trials in France

Italy29 sites

  • GSK Investigational Site

    Bari, Apulia, 70124

  • GSK Investigational Site

    Bologna, Emilia-Romagna, 40139

  • GSK Investigational Site

    Genoa, Liguria, 16132

  • GSK Investigational Site

    Genoa, Liguria, 16149

  • GSK Investigational Site

    Lecco, Lombardy, 23900

  • GSK Investigational Site

    Legnago, Veneto, 37045

  • GSK Investigational Site

    Meldola (FC), Emilia-Romagna, 47014

  • GSK Investigational Site

    Milan, Lombardy, 20141

  • GSK Investigational Site

    Milan, Lombardy, 20162

  • GSK Investigational Site

    Modena, Emilia-Romagna, 41100

  • GSK Investigational Site

    Monserrato, Sardinia, 09042

  • GSK Investigational Site

    Monza, Lombardy, 20052

  • GSK Investigational Site

    Naples, Campania, 80131

  • GSK Investigational Site

    Novara, Piedmont, 28100

  • GSK Investigational Site

    Orbassano (TO), Piedmont, 10043

  • GSK Investigational Site

    Padova, Veneto, 35128

  • GSK Investigational Site

    Palermo, Sicily, 90146

  • GSK Investigational Site

    Parma, Emilia-Romagna, 43100

  • GSK Investigational Site

    Perugia, Umbria, 06132

  • GSK Investigational Site

    Pisa, Tuscany, 56124

  • GSK Investigational Site

    Ravenna, Emilia-Romagna, 48100

  • GSK Investigational Site

    Rimini, Emilia-Romagna, 47900

  • GSK Investigational Site

    Rome, Lazio, 00133

  • GSK Investigational Site

    Rome, Lazio, 00152

  • GSK Investigational Site

    Rome, Lazio, 00189

  • GSK Investigational Site

    Rozzano (MI), Lombardy, 20089

  • GSK Investigational Site

    Siena, Tuscany, 53100

  • GSK Investigational Site

    Turin, Piedmont, 10126

  • GSK Investigational Site

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

Spain21 sites

  • GSK Investigational Site

    Barcelona, 08003

  • GSK Investigational Site

    Barcelona, 08035

  • GSK Investigational Site

    Barcelona, 08221

  • GSK Investigational Site

    Granada, 18013

  • GSK Investigational Site

    Granada, 18014

  • GSK Investigational Site

    Leganés, 28911

  • GSK Investigational Site

    Lleida, 25198

  • GSK Investigational Site

    Madrid, 28007

  • GSK Investigational Site

    Madrid, 28040

  • GSK Investigational Site

    Madrid, 28041

  • GSK Investigational Site

    Madrid, 28050

  • GSK Investigational Site

    Málaga, 29010

  • GSK Investigational Site

    Oviedo, 33006

  • GSK Investigational Site

    Sabadell, 08208

  • GSK Investigational Site

    San Sebastián de los Reyes, 28702

  • GSK Investigational Site

    Santander, 39008

  • GSK Investigational Site

    Santiago de Compostela, 15706

  • GSK Investigational Site

    Seville, 41013

  • GSK Investigational Site

    Seville, 41071

  • GSK Investigational Site

    Valencia, 46010

  • GSK Investigational Site

    Valencia, 46014

Other trials in Spain

United Kingdom20 sites

  • GSK Investigational Site

    Aberdeen, AB25 2ZN

  • GSK Investigational Site

    Bebington, CH63 4JY

  • GSK Investigational Site

    Belfast, BT9 7AB

  • GSK Investigational Site

    Birmingham, B9 5SS

  • GSK Investigational Site

    Cambridge, Cambridgeshire, CB2 2RE

  • GSK Investigational Site

    Cambridge, CB23 3RE

  • GSK Investigational Site

    Dundee, DD1 9SY

  • GSK Investigational Site

    Edinburgh, Midlothian, EH4 2XU

  • GSK Investigational Site

    Glasgow, G12 0YN

  • GSK Investigational Site

    Inverness, IV2 3UJ

  • GSK Investigational Site

    Leeds, LS9 7TF

  • GSK Investigational Site

    Leicester, Leicestershire, LE1 5WW

  • GSK Investigational Site

    Liverpool, L14 3PE

  • GSK Investigational Site

    London, SE1 9RT

  • GSK Investigational Site

    London, SW3 6JJ

  • GSK Investigational Site

    London, SW3 6NP

  • GSK Investigational Site

    Maidstone, ME16 9QQ

  • GSK Investigational Site

    Sheffield, S10 2SJ

  • GSK Investigational Site

    Sutton, Surrey, SM2 5PT

  • GSK Investigational Site

    Wythenshawe, Greater Manchester, M23 9LT

Other trials in United Kingdom

Canada18 sites

  • GSK Investigational Site

    Calgary, Alberta, T2N 4N2

  • GSK Investigational Site

    Edmonton, Alberta, T6G 1Z2

  • GSK Investigational Site

    Greenfield Park, Quebec, J4V 2H1

  • GSK Investigational Site

    Halifax, Nova Scotia, B3J 2Y9

  • GSK Investigational Site

    Hamilton, Ontario, L8V 5C2

  • GSK Investigational Site

    London, Ontario, N6A 5W9

  • GSK Investigational Site

    Montreal, Quebec, H1T 2M4

  • GSK Investigational Site

    Montreal, Quebec, H2L 4M1

  • GSK Investigational Site

    Montreal, Quebec, H3T1E2

  • GSK Investigational Site

    Montreal, Quebec, H4J 1C5

  • GSK Investigational Site

    Newmarket, Ontario, L3Y 2P9

  • GSK Investigational Site

    Québec, G1V 4G5

  • GSK Investigational Site

    Saint Catherines, Ontario, L2S 0A9

  • GSK Investigational Site

    Scarborough Village, Ontario, M1P 2V5

  • GSK Investigational Site

    Surrey, British Columbia, V3V 1N1

  • GSK Investigational Site

    Toronto, Ontario, M4C 3E7

  • GSK Investigational Site

    Toronto, Ontario, M5G 1X5

  • GSK Investigational Site

    Toronto, Ontario, M6R 1B5

Other trials in Canada

China18 sites

  • GSK Investigational Site

    Beijing

  • GSK Investigational Site

    Changchun, Jilin, 130012

  • GSK Investigational Site

    Changsha

  • GSK Investigational Site

    Chengdu, Sichuan, 610041

  • GSK Investigational Site

    Guangzhou, Guangdong, 510060

  • GSK Investigational Site

    Guangzhou, Guangdong, 510120

  • GSK Investigational Site

    Guangzhou

  • GSK Investigational Site

    Hangzhou, Zhejiang, 310003

  • GSK Investigational Site

    Hangzhou, Zhejiang, 310022

  • GSK Investigational Site

    Harbin

  • GSK Investigational Site

    Nanjing, Jiangsu, 210002

  • GSK Investigational Site

    Nanning, Guangxi, 530021

  • GSK Investigational Site

    Shanghai, 200030

  • GSK Investigational Site

    Shanghai, 200032

  • GSK Investigational Site

    Shanghai, 200433

  • GSK Investigational Site

    Tianjin, 300052

  • GSK Investigational Site

    Wuhan, Hubei, 430030

  • GSK Investigational Site

    Wuhan

Other trials in China

Australia16 sites

  • GSK Investigational Site

    Adelaide, South Australia, 5000

  • GSK Investigational Site

    Box Hill, Victoria, 3128

  • GSK Investigational Site

    Camperdown, New South Wales, 2050

  • GSK Investigational Site

    Chermside, Queensland, 4032

  • GSK Investigational Site

    Fitzroy, Victoria, 3065

  • GSK Investigational Site

    Garran, Australian Capital Territory, 2606

  • GSK Investigational Site

    Heidelberg, Victoria, 3084

  • GSK Investigational Site

    Hobart, Tasmania, 7000

  • GSK Investigational Site

    Nedlands, Western Australia, 6009

  • GSK Investigational Site

    Perth, Western Australia, 6001

  • GSK Investigational Site

    Richmond, Victoria, 3121

  • GSK Investigational Site

    South Brisbane, Queensland, 4101

  • GSK Investigational Site

    Tweed Heads, New South Wales, 2485

  • GSK Investigational Site

    Waratah, New South Wales, 2298

  • GSK Investigational Site

    Westmead, New South Wales, 2145

  • GSK Investigational Site

    Woolloongabba, Queensland, 4102

Other trials in Australia

Poland16 sites

  • GSK Investigational Site

    Bialystok, 15-276

  • GSK Investigational Site

    Bydgoszcz, 85-326

  • GSK Investigational Site

    Bydgoszcz, 85-796

  • GSK Investigational Site

    Chęciny, 26-060

  • GSK Investigational Site

    Gdansk, 80-952

  • GSK Investigational Site

    Głuchołazy, 41-340

  • GSK Investigational Site

    Krakow, 31-202

  • GSK Investigational Site

    Lodz, 90-549

  • GSK Investigational Site

    Lodz, 93-513

  • GSK Investigational Site

    Lublin, 20-954

  • GSK Investigational Site

    Poznan, 60-569

  • GSK Investigational Site

    Rzeszów

  • GSK Investigational Site

    Szczecin, 70-891

  • GSK Investigational Site

    Warsaw, 04-125

  • GSK Investigational Site

    Wroclaw, 53-439

  • GSK Investigational Site

    Zakopane, 34-500

Other trials in Poland

Greece15 sites

  • GSK Investigational Site

    Athens, 10676

  • GSK Investigational Site

    Athens, 115 27

  • GSK Investigational Site

    Athens, 11526

  • GSK Investigational Site

    Athens, 11527

  • GSK Investigational Site

    Athens, 145 64

  • GSK Investigational Site

    Chania, 73100

  • GSK Investigational Site

    Heraklion, 71110

  • GSK Investigational Site

    Larissa, 411 10

  • GSK Investigational Site

    Marousi, 15125

  • GSK Investigational Site

    Neo Faliro, 18547

  • GSK Investigational Site

    Pátrai, 26500

  • GSK Investigational Site

    Piraeus, 18537

  • GSK Investigational Site

    Pylaia, 57001

  • GSK Investigational Site

    Thessaloniki, 540 07

  • GSK Investigational Site

    Thessaloniki, 57010

Other trials in Greece

Japan15 sites

  • GSK Investigational Site

    Aichi, 464-8681

  • GSK Investigational Site

    Chiba, 277-8577

  • GSK Investigational Site

    Ehime, 791-0280

  • GSK Investigational Site

    Fukuoka, 807-8555

  • GSK Investigational Site

    Fukuoka, 811-1395

  • GSK Investigational Site

    Hiroshima, 730-8518

  • GSK Investigational Site

    Hyōgo, 673-8558

  • GSK Investigational Site

    Kanagawa, 241-8515

  • GSK Investigational Site

    Niigata, 951-8566

  • GSK Investigational Site

    Osaka, 534-0021

  • GSK Investigational Site

    Osaka, 537-8511

  • GSK Investigational Site

    Shizuoka, 411-8777

  • GSK Investigational Site

    Tokyo, 104-0045

  • GSK Investigational Site

    Tokyo, 113-8431

  • GSK Investigational Site

    Tokyo, 160-0023

Other trials in Japan

Belgium12 sites

  • GSK Investigational Site

    Antwerp, 2020

  • GSK Investigational Site

    Brussels, 1070

  • GSK Investigational Site

    Brussels, 1200

  • GSK Investigational Site

    Charleroi, 6000

  • GSK Investigational Site

    Duffel, 2570

  • GSK Investigational Site

    Edegem, 2650

  • GSK Investigational Site

    Genk, 3600

  • GSK Investigational Site

    Hasselt, 3500

  • GSK Investigational Site

    Jette, 1090

  • GSK Investigational Site

    Leuven, 3000

  • GSK Investigational Site

    Liège, 4000

  • GSK Investigational Site

    Namur, 5000

Other trials in Belgium

Hungary12 sites

  • GSK Investigational Site

    Budapest, 1529

  • GSK Investigational Site

    Budapest

  • GSK Investigational Site

    Deszk, 6772

  • GSK Investigational Site

    Győr, 9024

  • GSK Investigational Site

    Gyula, 5703

  • GSK Investigational Site

    Mátraháza, 3233

  • GSK Investigational Site

    Miskolc, 3529

  • GSK Investigational Site

    Nyíregyháza, 4400

  • GSK Investigational Site

    Pécs, 7623

  • GSK Investigational Site

    Pózva, 8900

  • GSK Investigational Site

    Székesfehérvár, 8000

  • GSK Investigational Site

    Szombathely, 9700

Other trials in Hungary

Ukraine11 sites

  • GSK Investigational Site

    Dnipropetrovsk, 49102

  • GSK Investigational Site

    Donetsk, 83092

  • GSK Investigational Site

    Kharkiv, 61070

  • GSK Investigational Site

    Kyiv, 01113

  • GSK Investigational Site

    Kyiv, 03115

  • GSK Investigational Site

    Kyiv, 04107

  • GSK Investigational Site

    Lviv, 79031

  • GSK Investigational Site

    Odesa, 65117

  • GSK Investigational Site

    Simferopol, 95023

  • GSK Investigational Site

    Uzhhorod, 88017

  • GSK Investigational Site

    Vinnytsia, 21029

Other trials in Ukraine

Russia10 sites

  • GSK Investigational Site

    Chelyabinsk, 454087

  • GSK Investigational Site

    Kazan', 420029

  • GSK Investigational Site

    Kursk, 305035

  • GSK Investigational Site

    Moscow, 115478

  • GSK Investigational Site

    Moscow, 129128

  • GSK Investigational Site

    Saint Petersburg, 197 089

  • GSK Investigational Site

    Saint Petersburg, 197758

  • GSK Investigational Site

    Saint Petersburg, 198255

  • GSK Investigational Site

    Stavropol, 355047

  • GSK Investigational Site

    Ufa, 450054

Other trials in Russia

Argentina9 sites

  • GSK Investigational Site

    C.a.b.a., Buenos Aires, C1425EHD

  • GSK Investigational Site

    Cipolletti, Río Negro Province, R8324EMB

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1430CLD

  • GSK Investigational Site

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1125ABD

  • GSK Investigational Site

    Córdoba, Córdoba Province, X5000JFK

  • GSK Investigational Site

    Quilmes, 1878

  • GSK Investigational Site

    Rosario, Santa Fe Province, S2000KZE

  • GSK Investigational Site

    San Miguel de Tucumán, 4000

  • GSK Investigational Site

    Santa Fe, 3000

Other trials in Argentina

Austria8 sites

  • GSK Investigational Site

    Graz, A-8036

  • GSK Investigational Site

    Innsbruck, 6020

  • GSK Investigational Site

    Linz, A-4010

  • GSK Investigational Site

    Linz, A-4020

  • GSK Investigational Site

    Salzburg, A-5020

  • GSK Investigational Site

    Vienna, 1130

  • GSK Investigational Site

    Vienna, A-1090

  • GSK Investigational Site

    Wels, A-4600

Other trials in Austria

Brazil8 sites

  • GSK Investigational Site

    Barretos, São Paulo, 14784-400

  • GSK Investigational Site

    Belo Horizonte, Minas Gerais, 30730-540

  • GSK Investigational Site

    Porto Alegre, Rio Grande do Sul, 90610 000

  • GSK Investigational Site

    Rio de Janeiro, 20230-130

  • GSK Investigational Site

    Santo André, São Paulo, 09060-650

  • GSK Investigational Site

    São Paulo, 01224-010

  • GSK Investigational Site

    São Paulo, 01308-050

  • GSK Investigational Site

    São Paulo, 01509-900

Other trials in Brazil

India7 sites

  • GSK Investigational Site

    Ahmedabad, 380 009

  • GSK Investigational Site

    Ahmedabad, 380016

  • GSK Investigational Site

    Bangalore, 560029

  • GSK Investigational Site

    Hyderabad, 500082

  • GSK Investigational Site

    Mumbai, 400012

  • GSK Investigational Site

    Mumbai, 400016

  • GSK Investigational Site

    Mumbai, 400020

Other trials in India

Taiwan7 sites

  • GSK Investigational Site

    Kaohsiung City, 833

  • GSK Investigational Site

    Taichung, 404

  • GSK Investigational Site

    Taichung, 40705

  • GSK Investigational Site

    Tainan, 704

  • GSK Investigational Site

    Taipei, 100

  • GSK Investigational Site

    Taipei, 112

  • GSK Investigational Site

    Taoyuan, 333

Other trials in Taiwan

Czechia6 sites

  • GSK Investigational Site

    Brno, 625 00

  • GSK Investigational Site

    Ostrava, 708 52

  • GSK Investigational Site

    Pilsen, 305 99

  • GSK Investigational Site

    Prague, 150 06

  • GSK Investigational Site

    Prague, 180 01

  • GSK Investigational Site

    Ústí nad Labem, 401 12

Other trials in Czechia

Israel6 sites

  • GSK Investigational Site

    Beersheba, 84101

  • GSK Investigational Site

    Haifa, 31096

  • GSK Investigational Site

    Jerusalem, 91120

  • GSK Investigational Site

    Kfar Saba, 44281

  • GSK Investigational Site

    Ramat Gan, 52621

  • GSK Investigational Site

    Zrifin, 70300

Other trials in Israel

South Korea6 sites

  • GSK Investigational Site

    Kyunggi-do, 410-769

  • GSK Investigational Site

    Seongnam-si, 463-707

  • GSK Investigational Site

    Seoul, 120-752

  • GSK Investigational Site

    Seoul, 135-710

  • GSK Investigational Site

    Seoul, 137-701

  • GSK Investigational Site

    Seoul, 138-736

Other trials in South Korea

Switzerland6 sites

  • GSK Investigational Site

    Aarau, 5001

  • GSK Investigational Site

    Basel, 4031

  • GSK Investigational Site

    Bern, 3010

  • GSK Investigational Site

    Bruderholz, 4101

  • GSK Investigational Site

    Thun, 3600

  • GSK Investigational Site

    Zurich, 8091

Other trials in Switzerland

Netherlands5 sites

  • GSK Investigational Site

    Amsterdam, 1105 AZ

  • GSK Investigational Site

    Harderwijk, 3844 DG

  • GSK Investigational Site

    Heerlen, 6419 PC

  • GSK Investigational Site

    Leeuwarden, 8934 AD

  • GSK Investigational Site

    Nieuwegein, 3435 CM

Other trials in Netherlands

Finland4 sites

  • GSK Investigational Site

    Helsinki, 00029

  • GSK Investigational Site

    Oulu, 90220

  • GSK Investigational Site

    Tampere, 33520

  • GSK Investigational Site

    Turku, 20520

Other trials in Finland

Ireland4 sites

  • GSK Investigational Site

    Dublin, 4

  • GSK Investigational Site

    Dublin, 8

  • GSK Investigational Site

    Dublin, 9

  • GSK Investigational Site

    Galway, Co Galway

Other trials in Ireland

Thailand4 sites

  • GSK Investigational Site

    Bangkok, 10110

  • GSK Investigational Site

    Bangkok, 10400

  • GSK Investigational Site

    Chiang Mai, 50200

  • GSK Investigational Site

    Hat Yai, 90110

Other trials in Thailand

Norway3 sites

  • GSK Investigational Site

    Oslo, 0027

  • GSK Investigational Site

    Oslo, 0407

  • GSK Investigational Site

    Trondheim, 7030

Other trials in Norway

Sweden3 sites

  • GSK Investigational Site

    Lund, SE-221 85

  • GSK Investigational Site

    Stockholm, SE-171 76

  • GSK Investigational Site

    Uppsala, SE-751 85

Other trials in Sweden

Estonia2 sites

  • GSK Investigational Site

    Tallinn, 13419

  • GSK Investigational Site

    Tartu, 51014

Other trials in Estonia

Hong Kong2 sites

  • GSK Investigational Site

    Kowloon

  • GSK Investigational Site

    Shatin

Other trials in Hong Kong

Singapore2 sites

  • GSK Investigational Site

    Singapore, 119074

  • GSK Investigational Site

    Singapore, 169610

Other trials in Singapore

About this study

Official title: GSK1572932A Antigen-Specific Cancer Immunotherapeutic as Adjuvant Therapy in Patients With Resectable MAGE-A3 Positive Non-Small Cell Lung Cancer

The purpose of this clinical trial is to demonstrate the benefit of the immunotherapeutic product GSK1572932A when given to patients with Non-Small Cell Lung Cancer, after removal of their tumor. A course of 13 injections will be administered over 27 months. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Being tested
GSK1572932A Antigen-Specific Cancer Immunotherapeutic, Placebo Control
Keywords
ASCI, Immunotherapeutic, MAGRIT, Tumor antigen, Non-small-cell lung cancer, Adjuvant cancer therapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK1572932A Antigen-Specific Cancer ImmunotherapeuticBiological

    Intramuscular administration, 13 doses

  • Placebo ControlBiological

    Intramuscular administration, 13 doses

Study groups in NCT00480025
Study groupRoleWhat they receive
GSK1572932 GroupExperimentalPatients received up to 13 doses of GSK1572932, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Receives: Biological: GSK1572932A Antigen-Specific Cancer Immunotherapeutic
Placebo GroupPlacebo comparatorPatients received up to 13 doses of placebo, 5 doses every 3 weeks followed by 8 doses every 12 weeks.
Receives: Biological: Placebo Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the Overall Population

    DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional \& distant metastasis \& 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; \& distant recurrence [any tumor arising in contralateral lung or outside hemithorax]). Deaths occurring without prior documentation of recurrence were considered as event \& not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. PYAR= n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.

    Measured: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

  2. Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the No-CT Population

    DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional \& distant metastasis \& 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; \& distant recurrence [any tumor arising in contralateral lung or outside hemithorax]). Deaths occurring without prior documentation of recurrence were considered as event \& not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. PYAR= n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.

    Measured: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Secondary outcomes (30)

  1. Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the CT Population

    DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional \& distant metastasis \& 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; \& distant recurrence [any tumor arising in contralateral lung or outside hemithorax]). Deaths occurring without prior documentation of recurrence were considered as event \& not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.

    Measured: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

  2. Person Year Rate (PYAR) as Regards Overall-survival (OS) in the Overall Population

    OS was defined as the time interval from randomization to the date of death, irrespective of the cause of death. Patients still alive were censored at the last visit they were known to be alive. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.

    Measured: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

  3. Person Year Rate (PYAR) as Regards Overall-survival (OS) in the No-CT Population

    OS was defined as the time interval from randomization to the date of death, irrespective of the cause of death. Patients still alive were censored at the last visit they were known to be alive. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.

    Measured: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

  4. Person Year Rate (PYAR) as Regards Overall-survival (OS) in the CT Population

    OS was defined as the time interval from randomization to the date of death, irrespective of the cause of death. Patients still alive were censored at the last visit they were known to be alive. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.

    Measured: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

  5. Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the Overall Population

    LCSS was defined as the time interval from randomization to the date of death due to lung cancer. Deaths due to other or unknown causes were censored at the date of death. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.

    Measured: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

  6. Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the No-CT Population

    LCSS was defined as the time interval from randomization to the date of death due to lung cancer. Deaths due to other or unknown causes were censored at the date of death. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.

    Measured: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

  7. Person Year Rate (PYAR) as Regards Lung-cancer Specific Survival (LCSS) in the CT Population

    LCSS was defined as the time interval from randomization to the date of death due to lung cancer. Deaths due to other or unknown causes were censored at the date of death. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median OS estimates were obtained non-parametrically by Kaplan-Meier method.

    Measured: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

  8. Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the Overall Population

    DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional \& distant metastasis \& 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; \& distant recurrence [any tumor arising in contralateral lung or outside hemithorax]). Deaths occurring without prior documentation of recurrence were considered as event \& not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. Median DFS KMEs in % were obtained non-parametrically by Kaplan-Meier method and confidence intervals (CIs) calculated using the Greenwood formula for standard error computation.

    Measured: KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment. Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

  9. Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the No-CT Population

    DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional \& distant metastasis \& 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; \& distant recurrence [any tumor arising in contralateral lung or outside hemithorax]). Deaths occurring without prior documentation of recurrence were considered as event \& not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. Median DFS KMEs in % were obtained non-parametrically by Kaplan-Meier method and confidence intervals (CIs) calculated using the Greenwood formula for standard error computation.

    Measured: KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

  10. Kaplan-Meier Estimate (KME) of 2, 3, 4 and 5-year as Regards Disease-free Survival (DFS) in the CT Population

    DFS = time interval from randomization to 1st evidence of recurrence/death, if occurring before. All recurrence types were included, including local, regional \& distant metastasis \& 2nd primary lung cancer (i.e. local recurrence, defined as a tumor within same lung or at bronchial stump; regional recurrence, involving a clinically or radiologically manifest disease in mediastinum or supraclavicular nodes; \& distant recurrence [any tumor arising in contralateral lung or outside hemithorax]). Deaths occurring without prior documentation of recurrence were considered as event \& not censored. If no event occurred by time of analysis, time to event was censored at last assessment date of patient. New 1ry cancers outside lungs were not considered as event. Median DFS KMEs in % were obtained non-parametrically by Kaplan-Meier method and confidence intervals (CIs) calculated using the Greenwood formula for standard error computation.

    Measured: KME assessed at 2, 3, 4 and 5-year (Y) post Dose 1 of treatment. Follow-up period was from administration of 1st dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

  11. Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the Overall Population

    DFSS was defined as the interval from randomization to the date of disease recurrence or death due to lung cancer. Patients who had died due to another cause than lung cancer were censored on their date of death and patients alive at the time of analysis were censored on the date of last assessment. Patients with no assessment post-randomization were censored on the date of randomization. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.

    Measured: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

  12. Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the No-CT Population

    DFSS was defined as the interval from randomization to the date of disease recurrence or death due to lung cancer. Patients who had died due to another cause than lung cancer were censored on their date of death and patients alive at the time of analysis were censored on the date of last assessment. Patients with no assessment post-randomization were censored on the date of randomization. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.

    Measured: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

  13. Person Year Rate (PYAR) as Regards Disease-free Specific Survival (DFSS) in the CT Population

    DFSS was defined as the interval from randomization to the date of disease recurrence or death due to lung cancer. Patients who had died due to another cause than lung cancer were censored on their date of death and patients alive at the time of analysis were censored on the date of last assessment. Patients with no assessment post-randomization were censored on the date of randomization. PYAR = n (number of subjects reported with at least 1 event) divided by T (sum of follow-up period [in years] censored at 1st occurrence of event in group). Median DFS estimates were obtained non-parametrically by Kaplan-Meier method.

    Measured: Period of follow-up was from administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

  14. Number of Subjects Seropositive for Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 S+)

    A seropositive subject for anti-MAGE-A3 antibodies was a subject with anti-MAGE-A3 antibodies >= the seropositivity cut-off of 27 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL).

    Measured: Pre-treatment (PRE), at Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (At 12M post W120)

  15. Number of Humoral Responders as Regards Anti-Melanoma AntiGEn (MAGE)-A3 Antibodies (Anti-MAGE-A3 HR)

    A seropositive/seronegative subject for anti-MAGE-A3 antibodies was a subject with anti-MAGE-A3 antibodies >=/< the seropositivity cut-off of 27 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL). A humoral responder as regards anti-MAGE-A3 antibodies was defined as 1) for initially seronegative patients, a patient with post-administration Anti-MAGE-A3 antibody concentration >= 27 EL.U/mL; 2) for initially seropositive patients: post-treatment administration antibody concentration >= 2 fold the pre-treatment antibody concentration.

    Measured: At Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)

  16. Number of Subjects Seropositive for Anti-protein D (PD) Antibodies (Anti-PD S+)

    A seropositive subject for anti-PD antibodies was a subject with anti-PD antibodies >= the seropositivity cut-off of 100 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL).

    Measured: Pre-treatment (PRE), at Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)

  17. Number of Humoral Responders as Regards Anti-protein D (PD) Antibodies (Anti-PD HR)

    A seropositive/seronegative subject for anti-PD antibodies was a subject with anti-PD antibodies ≥/< the seropositivity cut-off of 100 Enzyme-linked immunosorbent assay (ELISA) units per millilitre (EL.U/mL). A humoral responder as regards anti-PD antibodies was defined as 1) for initially seronegative patients, a patient with post-administration anti-PD antibody concentration ≥ 100 EL.U/mL; 2) for initially seropositive patients: post-administration antibody concentration ≥ 2 fold the pre-vaccination antibody concentration.

    Measured: At Weeks (W) 6 and 12, at Months (M) 9, 12, 18 and 30 and at one year after treatment concluding time point, i.e. at follow-up visit 2 at W120 added of one year (at 12M post W120)

  18. Health-related Quality of Life (HQL) Scores

    HQL was assessed using the EQ-5D generic health state classification and valuation system. The number and percentage of patients with each score within each dimension of the EQ-5D questionnaire (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) were tabulated at each assessment for each group. Each of these scores can take 3 levels: no problem (level 1), moderate problem (level 2) or extreme problem (level 3). Resulting descriptive mean and standard deviation (SD) for the EQ-5D Utility Value (EQ-5D UV) were tabulated. Valid EQ-5D data were defined as questionnaires assessed 1) on day of and before treatment administration; or 2) on day after treatment administration for W0, W6, W12; or 3)during follow-up visits or at time of recurrence. The EQ-5D total score ranges from -0.016 (worst health state) to 1.000 (best health state).

    Measured: At Week (W) 0 on day of treatment (DoT) (W0 DoT), W0 on day post treatment (DpT) (W0 DpT), W6 DoT, W6 DpT, W12 DoT, W12 DpT, Month (M) 6, M9, M12, M24, 6M post W120, at recurrence, and at 12M post W120

  19. Number of Patients With Abnormal Alanine Aminotransferase (ALT) Values by Maximum Grade

    The status of each patient as regards ALT laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G2. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.

    Measured: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

  20. Number of Patients With Abnormal Alanine Aspartate Aminotransferase (AST) Values by Maximum Grade

    The status of each patient as regards AST laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G2. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.

    Measured: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

  21. Number of Patients With Abnormal Alkaline Phosphatase (ALKP) Values by Maximum Grade

    The status of each patient as regards ALKP laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G2. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.

    Measured: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

  22. Number of Patients With Abnormal Bilirubin (BIL) Values by Maximum Grade

    The status of each patient as regards BIL laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0) and G1. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.

    Measured: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

  23. Number of Patients With Abnormal Creatinine (CREA) Values by Maximum Grade

    The status of each patient as regards CREA laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G2. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.

    Measured: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

  24. Number of Patients With Abnormal Haemoglobin (HGB) Values by Maximum Grade

    The status of each patient as regards HGB laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1, G2 and G3. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.

    Measured: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

  25. Number of Patients With Abnormal Leukocytes (LEU) Values by Maximum Grade

    The status of each patient as regards LEU laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1, G2 and G3. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.

    Measured: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

  26. Number of Patients With Abnormal Lymphocytes (LYM) Values by Maximum Grade

    The status of each patient as regards LYM laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1, G2 and G3. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.

    Measured: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

  27. Number of Patients With Abnormal Neutrophils (NEU) Values by Maximum Grade

    The status of each patient as regards NEU laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1, G2, G3 and G4. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.

    Measured: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

  28. Number of Patients With Abnormal Platelets (PLA) Values by Maximum Grade

    The status of each patient as regards PLA laboratory values at baseline (SCR) up to DLP was collected and graded according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. The post-treatment values were presented by worst grade versus baseline grade. SCR CTC grade statuses reported were unknown (UNK), Grade 0 (G0), G1 and G3. CTC grade statuses reported at DLP were G0, G1, G2, G3, G4, and UNK.

    Measured: From screening (SCR) to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

  29. Number of Patients With Any Adverse Events (AEs) and With AEs by Maximum Grade Reported - Up to Data Lock Point (DLP)

    An AE was any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs reported are here below tabulated irrespective of grade, as well as graded by maximum grade reported according to the Common Terminology Criteria (CTC) Adverse event terminology, version 3.0. Maximum grade reported and tabulated were Grade 1 (G1), G2, G3, G4 and G5. Any here below is defined as irrespective of CTC grade reported.

    Measured: Within the 31-day follow-up period post treatment administration, up to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

  30. Number of Patients With Serious Adverse Events (SAEs) - Up to Data Lock Point (DLP)

    A SAE is any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject, or was a Grade 4 AE according to CTC for Adverse Events, Version 3.0. Events part of natural course of lung cancer (i.e., disease progression, recurrence) were captured towards clinical efficacy assessment (CEA) and were not reported as SAEs. Death due to a progressive disease was similarly recorded towards CEA, but not as an SAE. However, if progression of lung cancer disease was greater than normally be expected, or if investigators considered that there was a causal relationship between treatment or protocol design/procedures and disease progression/ recurrence, then it was reported as SAE. Any new cancer (non-related to lung cancer) was reported as SAE.

    Measured: From screening (SCR) up to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2007 (estimated)
  2. Study start4 Oct 2007
  3. Primary completion6 Dec 2013
  4. Study completion23 Sep 2014

Why it stopped: The study was terminated following assessment of the lack of efficacy of the study product by the Independent Data monitoring Committee for the study.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
2,278 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00480025
Sponsor's protocol ID
109493
Other IDs
2007-001283-73
Status last verified
Nov 2020
First submitted
29 May 2007
Last updated
22 Dec 2020
Individual data sharing
Yes: IPD for this study is available via the Clinical Study Data Request site.

Publications

  • Vansteenkiste JF, Cho BC, Vanakesa T, De Pas T, Zielinski M, Kim MS, Jassem J, Yoshimura M, Dahabreh J, Nakayama H, Havel L, Kondo H, Mitsudomi T, Zarogoulidis K, Gladkov OA, Udud K, Tada H, Hoffman H, Bugge A, Taylor P, Gonzalez EE, Liao ML, He J, Pujol JL, Louahed J, Debois M, Brichard V, Debruyne C, Therasse P, Altorki N. Efficacy of the MAGE-A3 cancer immunotherapeutic as adjuvant therapy in patients with resected MAGE-A3-positive non-small-cell lung cancer (MAGRIT): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2016 Jun;17(6):822-835. doi: 10.1016/S1470-2045(16)00099-1. Epub 2016 Apr 27.

    PubMed 27132212

  • Dizier B, Callegaro A, Debois M, Dreno B, Hersey P, Gogas HJ, Kirkwood JM, Vansteenkiste JF, Sequist LV, Atanackovic D, Goeman J, van Houwelingen H, Salceda S, Wang F, Therasse P, Debruyne C, Spiessens B, Brichard VG, Louahed J, Ulloa-Montoya F. A Th1/IFNgamma Gene Signature Is Prognostic in the Adjuvant Setting of Resectable High-Risk Melanoma but Not in Non-Small Cell Lung Cancer. Clin Cancer Res. 2020 Apr 1;26(7):1725-1735. doi: 10.1158/1078-0432.CCR-18-3717. Epub 2019 Nov 15.

    PubMed 31732522

  • Zhu J, Yuan Y, Wan X, Yin D, Li R, Chen W, Suo C, Song H. Immunotherapy (excluding checkpoint inhibitors) for stage I to III non-small cell lung cancer treated with surgery or radiotherapy with curative intent. Cochrane Database Syst Rev. 2021 Dec 6;12(12):CD011300. doi: 10.1002/14651858.CD011300.pub3.

    PubMed 34870327

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GSK1572932A Antigen-Specific Cancer Immunotherapeutic in people with Lung Cancer, Non-Small Cell, run by GlaxoSmithKline at 620 sites in 34 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 620 sites in United States, Germany, France, Italy, Spain and 29 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Person Year Rate (PYAR) as Regards Disease-free Survival (DFS) in the Overall Population (time frame: From administration of first dose of GSK1572932 study product/placebo solution to data lock point (DLP) on 23 January 2014 (up to 5 years per patient)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00480025, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2020.

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