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Squamous Cell Lung CancerPhase 3ECLIPSENCT01082549

Trial of Gemcitabine/Carboplatin With or Without Iniparib (SAR240550) (a PARP1 Inhibitor) in Subjects With Previously Untreated Stage IV Squamous Non-Small-Cell Lung Cancer (NSCLC)

A Phase 3 study testing gemcitabine/carboplatin and gemcitabine/carboplatin plus Iniparib in people with Squamous Cell Lung Cancer, run by Sanofi at 142 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To evaluate the overall survival (OS) of patients with advanced squamous cell lung cancer receiving the combination of gemcitabine/carboplatin either with or without Iniparib. Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Squamous Cell Lung Cancer
What is being tested?
gemcitabine/carboplatin and gemcitabine/carboplatin plus Iniparib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
780 participants
Where
142 sitesin 14 countries
Study dates
Mar 2010to Apr 2013
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Eligible patients must meet the following criteria to be enrolled in the study:
  • Newly diagnosed, stage IV squamous cell lung cancer. This includes patients who present with disseminated metastases, and those with a malignant pleural or pericardial effusion (i.e., formerly stage IIIB in the 6th TNM staging system).
  • Patients who have received prior adjuvant therapy for early-stage lung cancer are eligible if at least 12 months have elapsed from that treatment.
  • Histologically confirmed squamous cell bronchogenic carcinoma. Patients whose tumors contain mixed non-small cell histologies are eligible, as long as squamous carcinoma is the predominant histology. Mixed tumors with small cell anaplastic elements are not eligible. Cytologic specimens obtained by brushings, washings, or needle aspiration of the defined lesion are acceptable.
  • Patients with previous radiotherapy as definitive therapy for locally advanced non-small cell lung cancer are eligible, as long as the recurrence is outside the original radiation therapy port. Radiation therapy must have been completed >4 weeks prior to the initiation of study treatment. Patients who have received chemo/radiation for locally advanced NSCLC are not eligible. Patients who have received palliative radiation therapy for symptomatic metastases must have completed treatment >14 days prior the initiation of the study treatment.
  • Presence of evaluable (measureable or non-measurable) disease.
Show all 17Show fewer
  • ECOG Performance Status of 0 or 1.
  • Laboratory values as follows:
  • Absolute neutrophil count (ANC) >1,500/microL and platelets >100,000/microL (≤72 hours prior to initial treatment).
  • Hemoglobin >9 g/dL (Note: Patients may be transfused or receive erythropoietin to maintain or exceed this level).
  • Bilirubin < ULN.
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal if no liver involvement or ≤5 times the upper limit of normal with liver involvement.
  • Creatinine <2.0 mg/dL, or creatinine clearance >40 mL/min (as calculated by the Cockcroft-Gault method.
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment and at least 6 months after the last dose of the study treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately. Sexually active men must agree to use a medically acceptable form of birth control during treatment and at least 6 months after the last dose. If a female partner becomes pregnant during the course of the study the treating physician should be informed immediately.
  • >18 years of age.
  • Ability to understand the nature of this study, give written informed consent, and comply with study requirements.
  • Patients entering this study must be willing to provide tissue from a previous tumor biopsy (if available) for correlative testing. An exception to this is when the national/local regulations prohibits some of the key activities of this research like the export of samples to third countries, storage of coded samples or global gene expression profiling without a pre-specified list of target genes. If tissue is not available, a patient will still be eligible for enrollment into the study.

Who cannot join

  • Prior treatment with gemcitabine, carboplatin (except in the adjuvant setting), or Iniparib.
  • Past or current history of neoplasm other than the entry diagnosis, with the exception of treated non-melanoma skin cancer or carcinoma in-situ of any primary site, or invasive cancers treated definitively, with treatment ending >5 years previously and no evidence of recurrences.
  • A history of cardiac disease, as defined by:
  • Malignant hypertension
  • Unstable angina
  • Congestive heart failure
Show all 17Show fewer
  • Myocardial infarction within the previous 6 months
  • Symptomatic, unstable or uncontrolled, cardiac arrhythmias. Patients who have stable, rate-controlled atrial fibrillation are eligible for study enrollment.
  • Active brain metastases. Patients with treated brain metastases are eligible, if (1) radiation therapy was completed at least 2 weeks prior to study entry; (2) follow-up scan shows no disease progression; and (3) patient does not require steroids.
  • Women who are pregnant or lactating.
  • Any serious, active infection (> Grade 2) at the time of treatment.
  • A serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
  • A major surgical procedure, or significant traumatic injury ≤28 days of beginning treatment, or anticipation of the need for major surgery during the course of the study.
  • Uncontrolled or intercurrent illness including, that in the opinion of the investigator may increase the risks associated with study participation or administration of the investigational products, or that may interfere with the interpretation of the results.
  • History of any medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with the study participation or administration of the investigational products, or that may interfere with the interpretation of the results.
  • Known or suspected allergy/hypersensitivity to any agent given in the course of this trial.
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

142 sites in 14 countries.

142 sites in 14 countries

United States67 sites

  • Investigational Site Number 840338

    Anaheim, California, 92801

  • Investigational Site Number 840343

    Athens, Georgia, 30607

  • Investigational Site Number 840213

    Augusta, Georgia, 30901

  • Investigational Site Number 840347

    Augusta, Georgia, 30901

  • Investigational Site Number 840311

    Bend, Oregon, 97701

  • Investigational Site Number 840202

    Bethesda, Maryland, 20817

  • Investigational Site Number 840306

    Birmingham, Alabama, 35205

  • Investigational Site Number 840210

    Bridgeton, Missouri, 63044

  • Investigational Site Number 840353

    Burbank, California, 91505

  • Investigational Site Number 840350

    Chapel Hill, North Carolina, 27599

  • Investigational Site Number 840352

    Charleston, South Carolina, 29403

  • Investigational Site Number 840103

    Chattanooga, Tennessee, 37404

  • Investigational Site Number 840208

    Chattanooga, Tennessee, 37404

  • Investigational Site Number 840313

    Chicago, Illinois, 60637

  • Investigational Site Number 840105

    Cincinnati, Ohio, 45242

  • Investigational Site Number 840302

    Cleveland, Ohio, 44106

  • Investigational Site Number 840348

    Cleveland, Ohio, 44195

  • Investigational Site Number 840203

    Collierville, Tennessee, 38017

  • Investigational Site Number 840106

    Columbia, South Carolina, 29210

  • Investigational Site Number 840335

    Columbus, Ohio, 43219

  • Investigational Site Number 840341

    Concord, California, 73112

  • Investigational Site Number 840336

    Denver, Colorado, 80205

  • Investigational Site Number 840317

    Duarte, California, 91010

  • Investigational Site Number 840330

    Durham, North Carolina, 27710

  • Investigational Site Number 840218

    Evansville, Indiana, 47630

  • Investigational Site Number 840216

    Fort Lauderdale, Florida, 33308

  • Investigational Site Number 840323

    Fort Worth, Texas, 76104

  • Investigational Site Number 840201

    Gainesville, Georgia, 30501

  • Investigational Site Number 840207

    Huntsville, Alabama, 35805

  • Investigational Site Number 840319

    Indianapolis, Indiana, 46260

  • Investigational Site Number 840215

    Jacksonville, Florida, 32256

  • Investigational Site Number 840339

    La Verne, California, 91750

  • Investigational Site Number 840217

    Lakeland, Florida, 33805

  • Investigational Site Number 840318

    Las Vegas, Nevada, 89135

  • Investigational Site Number 840301

    Lawrenceville, Georgia, 30045

  • Investigational Site Number 840309

    Loma Linda, California, 92354

  • Investigational Site Number 840307

    Los Angeles, California, 90095-7059

  • Investigational Site Number 840320

    Louisville, Kentucky, 40202

  • Investigational Site Number 840305

    Marietta, Georgia, 30060

  • Investigational Site Number 840327

    Maywood, California, 60153

  • Investigational Site Number 840322

    Morgantown, West Virginia, 26506

  • Investigational Site Number 840204

    Morristown, New Jersey, 07960

  • Investigational Site Number 840351

    Muscle Shoals, Alabama, 35661

  • Investigational Site Number 840101

    Nashville, Tennessee, 37203

  • Investigational Site Number 840315

    Newark, Delaware, 19713

  • Investigational Site Number 840219

    Newport News, Virginia, 23601

  • Investigational Site Number 840346

    Norwich, Connecticut, 06360

  • Investigational Site Number 840212

    Omaha, Nebraska, 68114

  • Investigational Site Number 840205

    Orlando, Florida, 32804

  • Investigational Site Number 840102

    Richmond, Virginia, 23230

  • Investigational Site Number 840337

    Royal Oak, Michigan, 48073

  • Investigational Site Number 840328

    Saint Louis Park, Minnesota, 55426

  • Investigational Site Number 840345

    Salisbury, Maryland, 21801

  • Investigational Site Number 840303

    San Diego, California, 92123

  • Investigational Site Number 840321

    Santa Rosa, California, 95403

  • Investigational Site Number 840104

    Sarasota, Florida, 34236

  • Investigational Site Number 840308

    Scarborough, Maine, 04074-9308

  • Investigational Site Number 840312

    Seattle, Washington, 98104

  • Investigational Site Number 840329

    South Bend, Indiana, 46601

  • Investigational Site Number 840220

    Spartanburg, South Carolina, 29303

  • Investigational Site Number 840326

    Stockton, California, 95204

  • Investigational Site Number 840344

    Tacoma, Washington, 98405

  • Investigational Site Number 840314

    Tucker, Georgia, 30084

  • Investigational Site Number 840310

    Vallejo, California, 94589

  • Investigational Site Number 840331

    Wauwatosa, Wisconsin, 53226

  • Investigational Site Number 840211

    West Reading, Pennsylvania, 19611

  • Investigational Site Number 840316

    Wichita, Kansas, 67214

Other trials in United States

France10 sites

  • Investigational Site Number 250007

    Brest, 29609

  • Investigational Site Number 250002

    Dijon, 21034

  • Investigational Site Number 250009

    Limoges, 87042

  • Investigational Site Number 250003

    Marseille, 13008

  • Investigational Site Number 250004

    Paris, 75651

  • Investigational Site Number 250010

    Pierre-Bénite, 69495

  • Investigational Site Number 250008

    Poitiers, 86021

  • Investigational Site Number 250001

    Saint-Herblain, 44805

  • Investigational Site Number 250006

    Strasbourg, 67100

  • Investigational Site Number 250005

    Tours, 37044

Other trials in France

Germany10 sites

  • Investigational Site Number 276002

    Amberg, 92224

  • Investigational Site Number 276004

    Berlin, 13125

  • Investigational Site Number 276007

    Frankfurt am Main, 60488

  • Investigational Site Number 276008

    Großhansdorf, 22927

  • Investigational Site Number 276010

    Halle, 06120

  • Investigational Site Number 276012

    Heidelberg, 69126

  • Investigational Site Number 276009

    Immenhausen, 34376

  • Investigational Site Number 276001

    Löwenstein, 74245

  • Investigational Site Number 276006

    München, 80336

  • Investigational Site Number 276003

    Oldenburg, 26121

Other trials in Germany

Spain10 sites

  • Investigational Site Number 724004

    A Coruña, 15006

  • Investigational Site Number 724009

    Badalona, 08916

  • Investigational Site Number 724003

    Barcelona, 08035

  • Investigational Site Number 724005

    Madrid, 28034

  • Investigational Site Number 724006

    Madrid, 28041

  • Investigational Site Number 724002

    Málaga, 29011

  • Investigational Site Number 724001

    Palma de Mallorca, 07198

  • Investigational Site Number 724008

    Seville, 41013

  • Investigational Site Number 724010

    Valencia, 46014

  • Investigational Site Number 724007

    Zaragoza, 50009

Other trials in Spain

Poland7 sites

  • Investigational Site Number 616006

    Bialystok, 15-069

  • Investigational Site Number 616001

    Krakow, 31 -202

  • Investigational Site Number 616007

    Lubin, 59-300

  • Investigational Site Number 616004

    Olsztyn, 10-228

  • Investigational Site Number 616008

    Torun, 87-100

  • Investigational Site Number 616002

    Warsaw, 02-781

  • Investigational Site Number 616005

    Wroclaw, 53-439

Other trials in Poland

Canada6 sites

  • Investigational Site Number 124003

    Edmonton, T6G 1Z2

  • Investigational Site Number 124006

    Greenfield Park, J4V 2H1

  • Investigational Site Number 124005

    London, N6A 4L6

  • Investigational Site Number 124007

    Oshawa, L1G 2B9

  • Investigational Site Number 124004

    Québec, G1V 4G5

  • Investigational Site Number 124001

    Toronto, M5G 2M9

Other trials in Canada

Italy6 sites

  • Investigational Site Number 380006

    Genova, 16132

  • Investigational Site Number 380001

    Novara, 28100

  • Investigational Site Number 380008

    Orbassano, 10043

  • Investigational Site Number 380002

    Perugia, 06128

  • Investigational Site Number 380003

    Roma, 00149

  • Investigational Site Number 380007

    Roma, 00189

Other trials in Italy

Netherlands5 sites

  • Investigational Site Number 528005

    Breda, 4818 CK

  • Investigational Site Number 528004

    Eindhoven, 5623 EJ

  • Investigational Site Number 528001

    Groningen, 9713 GZ

  • Investigational Site Number 528006

    Maastricht, 6229 HX

  • Investigational Site Number 528003

    Zwolle, 8011 JW

Other trials in Netherlands

Romania5 sites

  • Investigational Site Number 642002

    Alba Iulia, 510077

  • Investigational Site Number 642006

    Bucharest, 022328

  • Investigational Site Number 642001

    Cluj-Napoca, 400015

  • Investigational Site Number 642004

    Craiova, 200385

  • Investigational Site Number 642005

    Hunedoara, 331057

Other trials in Romania

Hungary4 sites

  • Investigational Site Number 348005

    Budapest, 1121

  • Investigational Site Number 348003

    Budapest, 1529

  • Investigational Site Number 348001

    Mátraháza, 3233

  • Investigational Site Number 348004

    Nyíregyháza, 4400

Other trials in Hungary

Israel4 sites

  • Investigational Site Number 376002

    Kfar Saba, 44281

  • Investigational Site Number 376005

    Petah Tikva, 49100

  • Investigational Site Number 376003

    Tel HaShomer, 52621

  • Investigational Site Number 376001

    Tzrifin, 70300

Other trials in Israel

United Kingdom4 sites

  • Investigational Site Number 826002

    Glasgow, G12 0YN

  • Investigational Site Number 826005

    Leeds, LS9 7TF

  • Investigational Site Number 826001

    Manchester, M20 4BX

  • Investigational Site Number 826006

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Belgium3 sites

  • Investigational Site Number 056004

    Bruges, 8310

  • Investigational Site Number 056003

    Brussels, 1090

  • Investigational Site Number 056001

    Liège, 4000

Other trials in Belgium

Luxembourg1 site

  • Investigational Site Number 442001

    Luxembourg, 1210

Other trials in Luxembourg

About this study

Official title: Randomized Phase 3 Trial of Gemcitabine/Carboplatin With or Without Iniparib (SAR240550) (a PARP1 Inhibitor) in Subjects With Previously Untreated Stage IV Squamous Non-Small-Cell Lung Cancer (NSCLC)

To evaluate the overall survival (OS) of patients with advanced squamous cell lung cancer receiving the combination of gemcitabine/carboplatin either with or without Iniparib.

Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.

Being tested
gemcitabine/carboplatin, gemcitabine/carboplatin plus Iniparib
Keywords
Patients with Previously Untreated Advanced Squamous Cell Lung Cancer

What participants receive

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

  • gemcitabine/carboplatinDrug

    i.v.

  • gemcitabine/carboplatin plus IniparibDrug

    i.v.

Study groups in NCT01082549
Study groupRoleWhat they receive
gemcitabine/carboplatinActive comparatorNot described
Receives: Drug: gemcitabine/carboplatin
gemcitabine/carboplatin plus IniparibExperimentalNot described
Receives: Drug: gemcitabine/carboplatin plus Iniparib

What is being measured

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

  1. overall survival

    Measured: 12 months, 24 months

Secondary outcomes (1)

  1. progression free survival

    Measured: 12 months

Timeline

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

  1. First posted8 Mar 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionApr 2013
  4. Study completionApr 2013

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
None (open label)
Enrolment
780 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01082549
Sponsor's protocol ID
EFC11553
Other IDs
20090321
Acronym
ECLIPSE
Status last verified
Feb 2016
First submitted
5 Mar 2010
Last updated
17 Mar 2016
Results posted
No
Data monitoring committee
Yes
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing gemcitabine/carboplatin and gemcitabine/carboplatin plus Iniparib in people with Squamous Cell Lung Cancer, run by Sanofi at 142 sites in 14 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 17 inclusion and 17 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: finished, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 142 sites in United States, France, Germany, Spain, Poland and 9 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

overall survival (time frame: 12 months, 24 months). 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 NCT01082549.

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 17 Mar 2016.

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