AzTrials
AzTrials

Limited Stage Lung Small Cell CarcinomaPhase 3NCT03811002

Testing the Addition of a New Immunotherapy Drug, Atezolizumab (MPDL3280A), to the Usual Chemoradiation (CRT) Therapy Treatment for Limited Stage Small Cell Lung Cancer (LS-SCLC)

A Phase 3 study testing 3-Dimensional Conformal Radiation Therapy, Atezolizumab and Biospecimen Collection in people with Limited Stage Lung Small Cell Carcinoma and Stage I Lung Cancer AJCC v8, run by National Cancer Institute (NCI) at 542 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This phase III trial studies how well chemotherapy and radiation therapy (chemoradiation) with or without atezolizumab works in treating patients with limited stage small cell lung cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
3-Dimensional Conformal Radiation Therapy, Atezolizumab and Biospecimen Collection
Could I receive a placebo?
No, everyone receives an active treatment
How many people
544 participants
Where
542 sitesin 2 countries
Study dates
26 Jul 2019to 21 Feb 2029
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

  • Pathologically (histologically or cytologically) proven diagnosis of limited stage small cell lung cancer (Stage Tx, T1-T4, N0-3, M0, American Joint Committee on Cancer [AJCC] staging, 8th edition [Ed.]), within 60 days prior to registration
  • Patients must have received one cycle of platinum/etoposide chemotherapy pre-registration (prior to study entry). Study registration must be within 21 days from day 1 of the pre-registration cycle of chemotherapy.
  • Patients must have had measurable disease (per Response Evaluation Criteria in Solid Tumors [RECIST], version 1.1) prior to the required pre-registration cycle of platinum/etoposide chemotherapy
  • Minimal staging requirements include:
  • History/physical examination within 30 days prior to registration
  • Positron emission tomography (PET)/computed tomography (CT) scan for staging within 60 days prior to registration
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  • CT chest and CT abdomen with IV contrast (unless contraindicated based on kidney function) within 60 days prior to registration; magnetic resonance imaging (MRI) abdomen with IV contrast allowed in place of CT abdomen
  • Note: If contrast allergy exists, premedication per institutional guidelines should be performed prior to obtaining CT with contrast. The only exception to this is a documented life-threatening allergy
  • MRI scan of the brain with contrast (preferred) or CT scan of the brain with contrast (allowable if there is a contraindication with MRI with contrast) within 30 days prior to registration
  • Age >= 18
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 30 days prior to registration
  • Absolute neutrophil count (ANC) >= 1,500/cells/mm^3 (prior to pre-registration cycle)
  • Platelet count >= 100,000 cells/mm^3 (prior to pre-registration cycle)
  • Hemoglobin >= 9 g/dL (prior to pre-registration cycle)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) (prior to pre-registration cycle)
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2.0 x ULN (prior to pre-registration cycle)
  • Adequate renal function within 30 days prior to registration defined as follows: Creatinine clearance >= 30 mL/min by the Cockcroft-Gault (C-G) equation
  • Patients presenting with a pleural effusion will be eligible if thoracentesis is cytologically negative and non-bloody or if pleural fluid is too small a volume to effectively sample by thoracentesis and does not show increased metabolic activity on CT/PET imaging
  • Negative serum pregnancy test within 14 days of registration for pre-menopausal women of childbearing potential
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry
  • Hepatitis B/C testing prior to enrollment for patients that have not been tested before. Note: This is required even if the patient has never shown or had symptoms of hepatitis
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial

Who cannot join

  • Definitive clinical or radiologic evidence of metastatic disease
  • Definitive surgical resection of small cell lung cancer
  • Prior invasive malignancy (except non-melanomatous skin cancer, localized prostate cancer, or any early stage cancer treated with curative intent resection) unless disease free for a minimum of 2 years (carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
  • More than 1 cycle of prior platinum-based chemotherapy for SCLC prior to enrollment; note that prior chemotherapy for a different cancer is allowable
  • Any prior atezolizumab or other immunotherapy agent
  • Prior radiotherapy to the lungs or mediastinum that would result in clinically significant overlap of radiation therapy fields; prior tangent fields for breast cancer with minimal overlap with target volumes are allowed per approval of study principal investigators (PIs)
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  • Patients with cytologically positive pleural or pericardial fluid are not eligible
  • An active, known or suspected autoimmune disease. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
  • Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
  • History of allogeneic organ transplant
  • History of primary immunodeficiency
  • Severe, active co-morbidity defined as follows:
  • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
  • Active tuberculosis
  • Active hepatitis B (chronic or acute) or hepatitis C infection. Note that if hepatitis status is unknown, hepatitis B/C testing is required
  • Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg]) test, a positive anti-HBc (antibody to hepatitis B core antigen), and a negative viral deoxyribonucleic acid (DNA) test (only obtained if HBsAg is found positive) are eligible
  • Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). (The HCV RNA test must be performed for patients who have a positive HCV antibody test.)
  • Known immunosuppressive disease, for example history of bone marrow transplant or chronic lymphocytic leukemia (CLL)
  • Chronic obstructive pulmonary disease (COPD) requiring chronic oral steroid therapy of > 10 mg prednisone daily or equivalent at the time of registration. Inhaled corticosteroids are not exclusionary
  • Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months
  • Transmural myocardial infarction within the last 3 months
  • Clinically significant interstitial lung disease
  • A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception for the duration of study treatment and for 150 days after the last dose of study drug (Arm 2); this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.

Trial locations and contacts

542 sites in 2 countries.

310 sites in 2 countries

United States300 sites

  • Hawaii Cancer Care - Westridge

    ‘Aiea, Hawaii, 96701

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • The Cancer Center of Hawaii-Pali Momi

    ‘Aiea, Hawaii, 96701

  • Providence Regional Cancer System-Aberdeen

    Aberdeen, Washington, 98520

  • Summa Health System - Akron Campus

    Akron, Ohio, 44304

  • Atrium Health Stanly/LCI-Albemarle

    Albemarle, North Carolina, 28002

  • Mayo Clinic Health System in Albert Lea

    Albert Lea, Minnesota, 56007

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • Alton Memorial Hospital

    Alton, Illinois, 62002

  • McFarland Clinic - Ames

    Ames, Iowa, 50010

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

  • Aspirus Cancer Care-Antigo-Volm Cancer Center

    Antigo, Wisconsin, 54409

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

  • Randolph Hospital

    Asheboro, North Carolina, 27203

  • Messino Cancer Centers

    Asheville, North Carolina, 28806

  • Grady Health System

    Atlanta, Georgia, 30303

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

  • Sutter Auburn Faith Hospital

    Auburn, California, 95602

  • UCHealth University of Colorado Hospital

    Aurora, Colorado, 80045

  • Rush-Copley Medical Center

    Aurora, Illinois, 60504

  • GenesisCare USA - Aventura FP

    Aventura, Florida, 33180

  • GenesisCare USA - Aventura

    Aventura, Florida, 33180

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • Saint Agnes Hospital

    Baltimore, Maryland, 21229

  • Summa Health System - Barberton Campus

    Barberton, Ohio, 44203

  • MaineHealth Coastal Cancer Treatment Center

    Bath, Maine, 04530

  • LSU Health Baton Rouge-North Clinic

    Baton Rouge, Louisiana, 70805

  • Our Lady of the Lake Physician Group

    Baton Rouge, Louisiana, 70808

  • Louisiana Hematology Oncology Associates LLC

    Baton Rouge, Louisiana, 70809

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Medical Center of Baton Rouge

    Baton Rouge, Louisiana, 70816

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • McLaren Cancer Institute-Bay City

    Bay City, Michigan, 48706

  • UHHS-Chagrin Highlands Medical Center

    Beachwood, Ohio, 44122

  • UM Upper Chesapeake Medical Center

    Bel Air, Maryland, 21014

  • MaineHealth Waldo Hospital

    Belfast, Maine, 04915

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

  • MaineHealth Maine Medical Center - Biddeford

    Biddeford, Maine, 04005

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • University of Alabama at Birmingham Cancer Center

    Birmingham, Alabama, 35233

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Saint Joseph's/Candler - Bluffton Campus

    Bluffton, South Carolina, 29910

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

  • Parkland Health Center-Bonne Terre

    Bonne Terre, Missouri, 63628

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

  • Ocean University Medical Center

    Brick, New Jersey, 08724

  • Dana-Farber Cancer Institute at Boston Medical Center - Brighton

    Brighton, Massachusetts, 02135

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

  • Crozer-Keystone Regional Cancer Center at Broomall

    Broomall, Pennsylvania, 19008

  • Henry Ford Cancer Institute-Downriver

    Brownstown, Michigan, 48183

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Cone Health Cancer Center at Alamance Regional

    Burlington, North Carolina, 27215

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Minnesota Oncology - Burnsville

    Burnsville, Minnesota, 55337

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

  • Cleveland Clinic Mercy Hospital

    Canton, Ohio, 44708

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Carlisle Regional Cancer Center

    Carlisle, Pennsylvania, 17015

  • IU Health North Hospital

    Carmel, Indiana, 46032

  • Caro Cancer Center

    Caro, Michigan, 48723

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Physicians' Clinic of Iowa PC

    Cedar Rapids, Iowa, 52402

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

  • Geauga Hospital

    Chardon, Ohio, 44024

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • Atrium Health Pineville/LCI-Pineville

    Charlotte, North Carolina, 28210

  • Levine Cancer Institute-SouthPark

    Charlotte, North Carolina, 28211

  • Atrium Health University City/LCI-University

    Charlotte, North Carolina, 28262

  • Levine Cancer Institute-Ballantyne

    Charlotte, North Carolina, 28277

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Chelsea Hospital

    Chelsea, Michigan, 48118

  • Saint Luke's Hospital

    Chesterfield, Missouri, 63017

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush MD Anderson Cancer Center

    Chicago, Illinois, 60612

  • University of Illinois

    Chicago, Illinois, 60612

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

  • Siteman Cancer Center at Saint Peters Hospital

    City of Saint Peters, Missouri, 63376

  • McLaren Cancer Institute-Clarkston

    Clarkston, Michigan, 48346

  • Michigan Healthcare Professionals Clarkston

    Clarkston, Michigan, 48346

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Henry Ford Macomb Hospital-Clinton Township

    Clinton Township, Michigan, 48038

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • UI Health Care Mission Cancer and Blood - West Des Moines Clinic

    Clive, Iowa, 50325

  • Baptist Memorial Hospital and Cancer Center-Collierville

    Collierville, Tennessee, 38017

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • UCHealth Memorial Hospital Central

    Colorado Springs, Colorado, 80909

  • Memorial Hospital North

    Colorado Springs, Colorado, 80920

  • Central Maryland Radiation Oncology in Howard County

    Columbia, Maryland, 21044

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Mount Carmel East Hospital

    Columbus, Ohio, 43213

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Grant Medical Center

    Columbus, Ohio, 43215

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • Doctors Hospital

    Columbus, Ohio, 43228

  • New Hampshire Oncology Hematology PA-Concord

    Concord, New Hampshire, 03301

  • Atrium Health Cabarrus/LCI-Concord

    Concord, North Carolina, 28025

  • UT MD Anderson - The Woodlands

    Conroe, Texas, 77384

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • UM Sylvester Comprehensive Cancer Center at Coral Gables

    Coral Gables, Florida, 33146

  • Mary Bird Perkins Cancer Center - Covington

    Covington, Louisiana, 70433

  • Greater Regional Medical Center

    Creston, Iowa, 50801

  • Siteman Cancer Center at West County Hospital

    Creve Coeur, Missouri, 63141

  • AMG Crystal Lake - Oncology

    Crystal Lake, Illinois, 60014

  • Carle at The Riverfront

    Danville, Illinois, 61832

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Corewell Health Dearborn Hospital

    Dearborn, Michigan, 48124

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

  • AdventHealth Porter

    Denver, Colorado, 80210

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan, 48236

  • Advocate Good Samaritan Hospital

    Downers Grove, Illinois, 60515

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • Dublin Methodist Hospital

    Dublin, Ohio, 43016

  • Saint Luke's Hospital of Duluth

    Duluth, Minnesota, 55805

  • Northeast Radiation Oncology Center

    Dunmore, Pennsylvania, 18512

  • The Cancer Institute at Saint Francis Hospital

    East Hills, New York, 11548

  • Hematology Oncology Associates of Central New York-East Syracuse

    East Syracuse, New York, 13057

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • Mayo Clinic Health System-Eau Claire Clinic

    Eau Claire, Wisconsin, 54701

  • Saint Elizabeth Healthcare Edgewood

    Edgewood, Kentucky, 41017

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Baptist Health Hardin

    Elizabethtown, Kentucky, 42701

  • Elmhurst Memorial Hospital

    Elmhurst, Illinois, 60126

  • Arnot Ogden Medical Center/Falck Cancer Center

    Elmira, New York, 14905

  • Ephrata Cancer Center

    Ephrata, Pennsylvania, 17522

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

  • Michigan Healthcare Professionals Farmington

    Farmington Hills, Michigan, 48334

  • Corewell Health Farmington Hills Hospital

    Farmington Hills, Michigan, 48336

  • UPMC Cancer Center at UPMC Horizon

    Farrell, Pennsylvania, 16121

  • Piedmont Fayette Hospital

    Fayetteville, Georgia, 30214

  • Augusta Health Center for Cancer and Blood Disorders

    Fishersville, Virginia, 22939

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • McLaren Cancer Institute-Flint

    Flint, Michigan, 48532

  • Singh and Arora Hematology Oncology PC

    Flint, Michigan, 48532

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Cancer Care and Hematology-Fort Collins

    Fort Collins, Colorado, 80528

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308

  • Lee Memorial Health System

    Fort Myers, Florida, 33901

  • Regional Cancer Center-Lee Memorial Health System

    Fort Myers, Florida, 33905

  • Parkview Regional Medical Center

    Fort Wayne, Indiana, 46845

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

  • UF Health Cancer Institute - Gainesville

    Gainesville, Florida, 32610

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • UM Baltimore Washington Medical Center/Tate Cancer Center

    Glen Burnie, Maryland, 21061

  • Crozer Regional Cancer Center at Brinton Lake

    Glen Mills, Pennsylvania, 19342

  • Glens Falls Hospital

    Glens Falls, New York, 12801

  • NorthShore University HealthSystem-Glenbrook Hospital

    Glenview, Illinois, 60026

  • CTCA at Western Regional Medical Center

    Goodyear, Arizona, 85338

  • Goshen Center for Cancer Care

    Goshen, Indiana, 46526

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • Altru Cancer Center

    Grand Forks, North Dakota, 58201

  • Nebraska Cancer Specialists/Oncology Hematology West PC

    Grand Island, Nebraska, 68803

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • UCHealth Greeley Hospital

    Greeley, Colorado, 80631

  • Bellin Memorial Hospital

    Green Bay, Wisconsin, 54301

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Cone Health Cancer Center

    Greensboro, North Carolina, 27403

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Saint Francis Cancer Center

    Greenville, South Carolina, 29607

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

  • Baptist Cancer Center-Grenada

    Grenada, Mississippi, 38901

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Mount Carmel Grove City Hospital

    Grove City, Ohio, 43123

  • The Cancer Institute of New Jersey Hamilton

    Hamilton, New Jersey, 08690

  • WellSpan Medical Oncology and Hematology

    Hanover, Pennsylvania, 17331

  • UPMC Pinnacle Cancer Center/Community Osteopathic Campus

    Harrisburg, Pennsylvania, 17109

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Advocate South Suburban Hospital

    Hazel Crest, Illinois, 60429

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • NorthShore University HealthSystem-Highland Park Hospital

    Highland Park, Illinois, 60035

  • South Carolina Cancer Specialists PC

    Hilton Head Island, South Carolina, 29926-3827

  • The Radiation Oncology Center-Hilton Head/Bluffton

    Hilton Head Island, South Carolina, 29926

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu, Hawaii, 96813

  • Queen's Cancer Cenrer - POB I

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • Kuakini Medical Center

    Honolulu, Hawaii, 96817

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • Mary Bird Perkins Cancer Center - Houma

    Houma, Louisiana, 70360

  • Terrebonne General Medical Center

    Houma, Louisiana, 70360

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

  • UT MD Anderson - West Houston

    Houston, Texas, 77079

  • Houston Methodist West Hospital

    Houston, Texas, 77094

  • Edwards Comprehensive Cancer Center

    Huntington, West Virginia, 25701

  • Cleveland Clinic Cancer Center Independence

    Independence, Ohio, 44131

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Community Cancer Center East

    Indianapolis, Indiana, 46219

  • Community Cancer Center South

    Indianapolis, Indiana, 46227

  • Franciscan Health Indianapolis

    Indianapolis, Indiana, 46237

  • Community Cancer Center North

    Indianapolis, Indiana, 46256

  • Allegiance Health

    Jackson, Michigan, 49201

  • MU Health Care Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

  • University of Wisconsin Carbone Cancer Center - Johnson Creek

    Johnson Creek, Wisconsin, 53038

  • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

    Jonesboro, Arkansas, 72401

  • Freeman Health System

    Joplin, Missouri, 64804

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Logan Health Medical Center

    Kalispell, Montana, 59901

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • University of Kansas Cancer Center - North

    Kansas City, Missouri, 64154

  • CHI Health Good Samaritan

    Kearney, Nebraska, 68847

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

  • Novant Health Cancer Institute - Kernersville

    Kernersville, North Carolina, 27284

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Covenant Health Cancer Centers

    Knoxville, Tennessee, 37916

  • Community Howard Regional Health

    Kokomo, Indiana, 46904

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Mayo Clinic Health System-Franciscan Healthcare

    La Crosse, Wisconsin, 54601

  • Providence Regional Cancer System-Lacey

    Lacey, Washington, 98503

  • Northwestern Medicine Lake Forest Hospital

    Lake Forest, Illinois, 60045

  • The Watson Clinic

    Lakeland, Florida, 33805

  • Monmouth Medical Center Southern Campus

    Lakewood, New Jersey, 08701

  • Lancaster General Ann B Barshinger Cancer Institute

    Lancaster, Pennsylvania, 17601

  • Lancaster General Hospital

    Lancaster, Pennsylvania, 17602

  • Karmanos Cancer Institute at McLaren Greater Lansing

    Lansing, Michigan, 48910

  • Mid-Michigan Physicians-Lansing

    Lansing, Michigan, 48912

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

  • McLaren Cancer Institute-Lapeer Region

    Lapeer, Michigan, 48446

  • OptumCare Cancer Care at Charleston

    Las Vegas, Nevada, 89102

  • Radiation Oncology Centers of Nevada Central

    Las Vegas, Nevada, 89106

  • Radiation Oncology Centers of Nevada Southeast

    Las Vegas, Nevada, 89119

  • OptumCare Cancer Care at Fort Apache

    Las Vegas, Nevada, 89183

  • Cancer Centers of Southwest Oklahoma Research

    Lawton, Oklahoma, 73505

  • UT MD Anderson - League City

    League City, Texas, 77573

  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center

    Lebanon, New Hampshire, 03756

  • Sechler Family Cancer Center

    Lebanon, Pennsylvania, 17042

  • University of Kansas Cancer Center - Lee's Summit

    Lee's Summit, Missouri, 64064

  • Geisinger Medical Oncology-Lewisburg

    Lewisburg, Pennsylvania, 17837

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • CommonSpirit Saint Joseph Medical Center - East Lexington

    Lexington, Kentucky, 40509

  • AMG Libertyville - Oncology

    Libertyville, Illinois, 60048

  • Saint Rita's Medical Center

    Lima, Ohio, 45801

  • Cancer Partners of Nebraska

    Lincoln, Nebraska, 68516

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • AdventHealth Littleton

    Littleton, Colorado, 80122

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740

  • Los Angeles General Medical Center

    Los Angeles, California, 90033

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • Norton Hospital Pavilion and Medical Campus

    Louisville, Kentucky, 40202

  • The James Graham Brown Cancer Center at University of Louisville

    Louisville, Kentucky, 40202

  • Baptist Health Louisville

    Louisville, Kentucky, 40207

  • Norton Audubon Hospital and Medical Campus

    Louisville, Kentucky, 40217

  • Norton Brownsboro Hospital and Medical Campus

    Louisville, Kentucky, 40241

  • Medical Center of the Rockies

    Loveland, Colorado, 80538

  • Covenant Medical Center-Lakeside

    Lubbock, Texas, 79410

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Michigan Healthcare Professionals Macomb

    Macomb, Michigan, 48044

  • University of Wisconsin Carbone Cancer Center - University Hospital

    Madison, Wisconsin, 53792

  • Michigan Healthcare Professionals Madison Heights

    Madison Heights, Michigan, 48071

  • Southern Ocean County Medical Center

    Manahawkin, New Jersey, 08050

  • Solinsky Center for Cancer Care

    Manchester, New Hampshire, 03103

Other trials in United States

Japan10 sites

  • Gunma University Hospital

    Gunma, Maebashi, 371-8511

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Kagoshima City Hospital

    Kagoshima, Kagoshima-ken, 890-8760

  • Shikoku Cancer Center

    Matsuyama, 791-0280

  • Kyorin University Hospital

    Mitaka-shi, Tokyo, 181-8611

  • Niigata University Medical and Dental Hospital

    Niigata, Niigata, 951-8520

  • Saitama Medical University International Medical Center

    Saitama, 350-1298

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

  • Tohoku University School of Medicine

    Sendai, Aoba-ku, 980-8574

  • Ehime University Hospital

    Tōon, Ehime, 791-0295

Other trials in Japan

About this study

Official title: Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab

This phase III trial studies how well chemotherapy and radiation therapy (chemoradiation) with or without atezolizumab works in treating patients with limited stage small cell lung cancer. Drugs used in chemotherapy, such as etoposide, cisplatin, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving chemoradiation with or without atezolizumab may work better in treating patients with limited stage small cell lung cancer.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To compare overall survival (OS) for patients with LS-SCLC treated with chemoradiation +/- atezolizumab.

SECONDARY OBJECTIVES:

  1. To compare progression free survival (PFS) for patients with limited stage small cell lung cancer (LS-SCLC) treated with chemoradiation +/- atezolizumab.

II. To determine overall response rate (ORR), rates of local control, and distant metastases free survival with chemoradiation +/- atezolizumab.

III. To characterize immune mediated and non-immune mediated toxicity from chemoradiotherapy plus atezolizumab.

IV. To compare quality of life, as measured by the Functional Assessment of Cancer Therapy-Trial Outcome Index (FACT-TOI), for patients undergoing chemoradiation +/- atezolizumab.

  1. To evaluate the quality-adjusted survival, using scores from the 5-level EuroQol 5-dimensional questionnaire (EQ-5D-5L), of chemoradiation +/- atezolizumab for patients with LS-SCLC.

VI. To characterize fatigue, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS), following chemoradiation +/- atezolizumab.

VII. To determine the association of small cell lung cancer (SCLC) molecular subtypes with clinical outcomes.

EXPLORATORY OBJECTIVES:

  1. To collect biospecimens at baseline, day 1 and 3 months after the end of chemoradiotherapy, to allow for future analyses.

II. To characterize patient-reported symptomatic toxicities measured by the Patient-Reported Outcomes - Common Terminology Criteria for Adverse Events (PRO-CTCAE).

III. To characterize the concordance between tumor and circulating cell-free deoxyribonucleic acid (cfDNA)-determined molecular subtypes.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive etoposide intravenously (IV) on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo three-dimensional conformal radiation therapy (3D-CRT) or intensity-modulated radiation therapy (IMRT) twice daily (BID) for approximately 3 weeks or once daily (QD) for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.

ARM II: Patients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.

After completion of study treatment, patients are followed up every 3 months for 2 years, then every 6 months for 3 years, then annually thereafter.

Being tested
3-Dimensional Conformal Radiation Therapy, Atezolizumab, Biospecimen Collection, Carboplatin, Cisplatin
Medical subject headings
Lung Neoplasms

What participants receive

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

  • 3-Dimensional Conformal Radiation TherapyRadiation

    Also called 3-dimensional radiation therapy, 3D Conformal, 3D CONFORMAL RADIATION THERAPY, 3D CRT

    Undergo 3D-CRT

  • AtezolizumabDrug

    Also called MPDL 3280A, MPDL 328OA, MPDL-3280A, MPDL3280A

    Given IV

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

    Correlative studies

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • CisplatinDrug

    Also called Abiplatin, Blastolem, Briplatin, CDDP

    Given IV

  • EtoposideDrug

    Also called Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar

    Given IV

  • Intensity-Modulated Radiation TherapyRadiation

    Also called IMRT, Intensity modulated radiation therapy (procedure), Intensity Modulated RT, Intensity-Modulated Radiotherapy

    Undergo IMRT

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

  • Questionnaire AdministrationOther

    Ancillary studies

Study groups in NCT03811002
Study groupRoleWhat they receive
Arm I (chemotherapy, radiation therapy)Active comparatorPatients receive etoposide IV on days 1-3 and cisplatin IV or carboplatin IV on day 1. Cycles repeat every 21 days for 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo 3D-CRT or IMRT BID for approximately 3 weeks or QD for approximately 6-7 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
Receives: Radiation: 3-Dimensional Conformal Radiation Therapy; Procedure: Biospecimen Collection; Drug: Carboplatin; Drug: Cisplatin; Drug: Etoposide; Radiation: Intensity-Modulated Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration
Arm II (chemotherapy, radiation therapy, atezolizumab)ExperimentalPatients receive treatment as in Arm I. Patients also receive atezolizumab IV over 30-60 minutes on day 1 or 2 of each chemotherapy cycle. Cycles repeat every 3 weeks for 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients undergo blood specimen collection throughout the trial.
Receives: Radiation: 3-Dimensional Conformal Radiation Therapy; Drug: Atezolizumab; Procedure: Biospecimen Collection; Drug: Carboplatin; Drug: Cisplatin; Drug: Etoposide; Radiation: Intensity-Modulated Radiation Therapy; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

What is being measured

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

  1. Overall Survival

    Survival rates and median survival time are estimated using the Kaplan-Meier method, censoring participants alive at time of analysis.

    Measured: Randomization to date of death due or last follow-up. Median follow-up at the time of analysis was 23.8 months.

Secondary outcomes (9)

  1. Progression Free Survival (PFS)

    PFS failure event is defined as progressive disease (PD) determined by investigator per the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death due to any cause. PD is defined as at least a 20% increase in the sum of longest diameters of target lesions, and an absolute increase of at least 5 mm. The appearance of any new lesions is also considered progression. PFS rates and median PFS time are estimated using the Kaplan-Meier method, censoring participants alive without progression at the date of their last evaluable radiographic tumor assessment.

    Measured: From randomization to progression or death due to any cause, whichever occurs first, or last tumor assessment if alive. MMedian follow-up at the time of analysis was 23.8 months.

  2. Number of Participants by Highest Grade Adverse Event Reported

    Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.

    Measured: Randomization to last follow-up. Median follow-up at the time of analysis was 23.8 months.

  3. Percentage of Participants With Confirmed Objective Response (Objective Response Rate (ORR))

    Objective response rate (ORR) is defined as the proportion of subjects whose best overall response (BOR) is a confirmed complete or partial response as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 on two consecutive occasions ≥4 weeks apart.

    Measured: Randomization to last radiographic tumor assessment. Median follow-up at the time of analysis was 23.8 months.

  4. Percentage of Participants With Local Progression

    Local progression is defined as intrathoracic tumor progression (failure in the lobe of the primary tumor or mediastinal lymph nodes) by RECIST 1.1 criteria determined by the investigator. Local progression rates are estimated by the cumulative incidence method, treating non-local progression (i.e., distant metastasis or failure in a different lung) and death without local progression as competing risks, and otherwise censoring participants alive at last tumor assessment. Treatment effect comparisons will utilize a cause-specific hazard function in which competing risks are censored.

    Measured: From randomization to local progression, other progression, or death, whichever occurs first, or last tumor assessment if alive. Median follow-up at the time of analysis was 23.8 months. 1-, 2-, and 3-year rates are reported.

  5. Distant Metastases-free Survival (DMFS)

    DMFS failure event is defined as first date of documented distant metastases (or failures in a different lung lobe) or death due to any cause, whichever occurs first. Participants with local progression prior to such an event are censored on the date of local progression. Participants with no post-baseline tumor assessment and alive at last follow-up are censored on the date of randomization. Participants alive without distant metastasis, failures in a different lung lobe, or local progression are censored on the date of their last evaluable radiographic tumor assessment. DMFS rates and median DMFS time are estimated using the Kaplan-Meier method.

    Measured: Randomization to DMFS event or local progression, whichever occurs first, or last tumor assessment if alive. Median follow-up at the time of analysis was 23.8 months.

  6. Percent of Participants With Deterioration in Functional Assessment of Cancer Therapy-Trial Outcome Index (FACT-TOI)

    FACT-TOI is a measure of 21 items that sums the functional well-being (FWB), physical well-being (PWB), and the lung cancer subscale (LCS) of the Functional Assessment of Cancer Therapy - Lung (FACT-L) quality of life (QOL) instrument. The FACT-TOI total score ranges from 0 to 84 with higher scores indicating better quality of life and functioning. Clinically meaningful decline is defined as a decrease from baseline of at least 5 points.

    Measured: Baseline and 15 months after completion of chemoradiation (approximately 18 months after randomization)

  7. Quality-adjusted Survival Months

    Quality-adjusted survival is calculated as the sum of weighted time intervals. Weight is the EuroQol 5-dimensional 5-level (EQ-5d-5L) index score, which measures health-related quality of life and ranges from 0 (death) to 1 (full health).

    Measured: Baseline to death, last follow-up or two years, whichever occurs first.

  8. Change From Baseline in the 7 Item Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Short Form Score

    The PROMIS fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible scores range from 29.4 to 83.2, with higher scores indicating more fatigue. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased fatigue.

    Measured: Baseline and 15 months after completion of chemoradiation (approximately 18 months after randomization)

  9. Molecular Subtyping

    Measured: Up to 5 years

Timeline

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

  1. First posted22 Jan 2019
  2. Study start26 Jul 2019
  3. Primary completion21 Apr 2024
  4. Study completion21 Feb 2029 (estimated)

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
544 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03811002
Sponsor's protocol ID
NCI-2019-00178
Other IDs
NCI-2019-00178, NRG-LU005, NRG-LU005, U10CA180868
Status last verified
Aug 2026
First submitted
18 Jan 2019
Last updated
27 Aug 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page

Publications

  • Movsas B, Hu C, Higgins KA, Ross HJ, Jabbour SK, Kozono D, Owonikoko TK, Xiao C, Shoji T, Faller BA, Mohindra P, Dib EG, Brownstein J, Chun SG, Kuzma CS, Kotecha R, Onitilo A, Mulford D, Paulus R, Bradley JD, Bruner DW. Comprehensive Patient-Reported Outcomes from NRG Oncology/Alliance LU005: A Randomized Trial of Chemoradiation With or Without Atezolizumab in Limited-Stage SCLC. J Thorac Oncol. 2026 Jul 30:104117. doi: 10.1016/j.jtho.2026.104117. Online ahead of print.

    PubMed 42532339

  • Higgins KA, Hu C, Ross HJ, Jabbour SK, Kozono DE, Owonikoko TK, Ritter TA, Williams TM, Welsh J, Simko JP, Movsas B, Xiao C, Kaira K, Gupta AK, Mohindra P, Dib EG, Brownstein J, Chun S, Kuzma CS, Kotecha R, Onitilo AA, Chen Y, Stinchcombe TE, Wang X, Paulus R, Bradley JD. Chemoradiation +/- Atezolizumab in Limited-Stage Small Cell Lung Cancer: Results of NRG Oncology/Alliance LU005. J Clin Oncol. 2026 Mar 10;44(8):630-640. doi: 10.1200/JCO-25-01569. Epub 2026 Jan 13.

    PubMed 41529214

  • Higgins KA, Thomas A, Soto N, Paulus R, George TJ, Julian TB, Hartson Stine S, Markham MJ, Werner-Wasik M. Creating and Implementing a Principal Investigator Tool Kit for Enhancing Accrual to Late Phase Clinical Trials: Development and Usability Study. JMIR Cancer. 2022 Aug 25;8(3):e38514. doi: 10.2196/38514.

    PubMed 36006678

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 3-Dimensional Conformal Radiation Therapy, Atezolizumab and Biospecimen Collection in people with Limited Stage Lung Small Cell Carcinoma and Stage I Lung Cancer AJCC v8, run by National Cancer Institute (NCI) at 542 sites in 2 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 22 inclusion and 25 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: under way, not looking for participants, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 542 sites in United States, Japan. 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?

Yes. Results are posted in the registry (first posted 12 Jun 2025). 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?

Overall Survival (time frame: Randomization to date of death due or last follow-up. Median follow-up at the time of analysis was 23.8 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 NCT03811002, 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 27 Aug 2026.

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