AzTrials
AzTrials

Extensive Stage Lung Small Cell CarcinomaPhase 2/3NCT04402788

Testing the Addition of Radiation Therapy to the Usual Immune Therapy Treatment (Atezolizumab) for Extensive Stage Small Cell Lung Cancer, The RAPTOR Trial

A Phase 2/3 study testing Atezolizumab, Biospecimen Collection and Computed Tomography in people with Extensive Stage Lung Small Cell Carcinoma, run by National Cancer Institute (NCI) at 411 sites in United States.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

This phase II/III trial compares the effect of adding radiation therapy to the usual maintenance therapy with atezolizumab versus atezolizumab alone in patients who have already received atezolizumab plus chemotherapy for the treatment of small cell lung cancer that has spread outside of the lung or to other parts of… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Atezolizumab, Biospecimen Collection and Computed Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
411 sitesUnited States
Study dates
7 Jan 2021to 30 Apr 2027
Phase
Phase 2/3
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

  • Any confirmation (cytologic, histologic, or pathologic) of extensive stage small cell lung cancer at any site, either primary or metastases
  • Partial response (PR) or stable disease (SD) after 4-6 cycles of etoposide/platinum (E/P) doublet plus atezolizumab by re-staging scans (positron emission tomography [PET]/computed tomography [CT] scan, diagnostic CT scan, magnetic resonance imaging [MRI] optional per treating physician); atezolizumab should continue through randomization. Patients must be randomized within 9 weeks of last dose of etoposide/platinum (if not receiving PCI) or 6 weeks from completion of prophylactic cranial irradiation (PCI)
  • NOTE: Patients must have at least 3 cycles of E/P plus atezolizumab. They can have one cycle of induction E/P without concurrent atezolizumab if unable to receive concurrent E/P combined with atezolizumab for all cycles of induction therapy
  • Patients must have measurable disease (per Response Evaluation Criteria in Solid Tumors [RECIST]) and 3 or fewer observable liver metastases and no evidence of progressive disease (per RECIST) at time of enrollment
  • At time of enrollment after induction E/P chemotherapy and atezolizumab, if there is a pleural effusion, patients will be eligible if thoracentesis is cytologically negative 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
  • Appropriate stage for study entry based on the following diagnostic workup:
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  • History/physical examination within 14 days prior to registration;
  • Imaging within 42 days prior to registration to include:
  • MRI brain with contrast or CT brain with contrast
  • CT chest, abdomen and pelvis or whole body PET/CT scan any time after the fourth cycle of chemotherapy and prior to registration
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 14 days prior to registration
  • Absolute neutrophil count (ANC) >= 1,000/cells/mm^3 (within 14 days prior to registration)
  • Platelets >= 75,000 cells/mm^3 (within 14 days prior to registration)
  • Hemoglobin >= 8 g/dL (within 14 days prior to registration)
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) (within 14 days prior to registration)
  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x ULN (AST and/or ALT =< 5 ULN for patients with liver involvement) (within 14 days prior to registration)
  • Alkaline phosphatase =< 2.5 x ULN (=< 5 ULN for patients with documented liver involvement or bone metastases) (within 14 days prior to registration)
  • Adequate renal function = Creatinine clearance >=40 mL/min by the Cockcroft-Gault (C-G) equation: (within 14 days prior to registration)
  • Upfront radiation therapy of symptomatic metastatic site is permissible if causing symptoms such as pain or impending fracture
  • Patients with brain metastases are eligible after receiving whole brain radiation before enrollment (anytime during induction systemic therapy). Whole brain radiation can be delivered with hippocampal sparing or 3-D conformal technique. Patients with irradiated brain metastases are eligible if they are clinically stable from a neurological standpoint after completing radiotherapy (e.g. not having uncontrolled seizures) and do not require use of steroids above a dose of 10 mg of prednisone daily
  • For women of childbearing potential, a negative serum or urine pregnancy test within 14 days prior to registration.
  • Note: Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
  • Women < 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy)
  • Women >= 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses > 1 year ago, had chemotherapy-induced menopause with last menses > 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy)
  • Patients positive for human immunodeficiency virus (HIV) on effective anti-retroviral therapy with undetectable viral load within 6 months and a stable regimen of highly active anti-retroviral (HAART) HIV-positive patients must have no requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry

Who cannot join

  • Metastatic disease invading the liver (> 3 metastases), heart or > 10 metastatic sites detectable after induction systemic therapy. Each visible bone metastasis on radiographic scan counts as one site
  • Patients with a concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen with atezolizumab or radiation
  • Prior radiotherapy in the thorax that would result in overlapping RT fields, unless the overlapping fields meet acceptable dose constraints for normal tissue
  • Active autoimmune disease, including, but not limited to: systemic lupus erythematosus; rheumatoid arthritis; inflammatory bowel disease (e.g. Crohn's, ulcerative colitis); vascular thrombosis associated with antiphospholipid syndrome; Wegener's granulomatosis; Sjogren's syndrome; Guillain-Barre syndrome; multiple sclerosis; vasculitis; or glomerulonephritis.
  • If the autoimmune disease is not active for over 3 years and the patient is not receiving immunosuppressive treatment such as methotrexate or steroids above a dose equivalent to 10 mg prednisone daily, the patient is eligible.
  • Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible
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  • Patients with controlled type 1 diabetes mellitus on a stable insulin regimen are eligible
  • Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations are excluded only if they have active disease with acute exacerbation and on immunosuppressive medications within the 12 months prior to enrollment. They are eligible otherwise.
  • Severe, active co-morbidity defined as follows:
  • 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;
  • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease
  • Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) 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;
  • History of recent myocardial infarction within 6 months prior to registration.
  • Clinically significant interstitial lung disease
  • Pregnancy: Administration of atezolizumab may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study treatment, and for 5 months (150 days) after the last dose of study agent. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
  • Women who are breastfeeding and unwilling to discontinue
  • History of allogeneic organ transplant
  • Patients who have had immunotherapy-induced pneumonitis

Trial locations and contacts

411 sites in 1 country.

300 sites in 1 country

United States300 sites

  • Hawaii Cancer Care - Westridge

    ‘Aiea, Hawaii, 96701

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • Cleveland Clinic Akron General

    Akron, Ohio, 44307

  • Atrium Health Stanly/LCI-Albemarle

    Albemarle, North Carolina, 28002

  • Lovelace Medical Center-Saint Joseph Square

    Albuquerque, New Mexico, 87102

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • Lovelace Radiation Oncology

    Albuquerque, New Mexico, 87109

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • Saint Luke's Cancer Center - Allentown

    Allentown, Pennsylvania, 18104

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

  • UI Health Care Mission Cancer and Blood - Ankeny Clinic

    Ankeny, Iowa, 50023

  • Aspirus Cancer Care-Antigo-Volm Cancer Center

    Antigo, Wisconsin, 54409

  • Grady Health System

    Atlanta, Georgia, 30303

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

  • Mount Sinai Comprehensive Cancer Center at Aventura

    Aventura, Florida, 33180

  • University of Maryland/Greenebaum Cancer Center

    Baltimore, Maryland, 21201

  • MaineHealth Coastal Cancer Treatment Center

    Bath, Maine, 04530

  • UPMC-Heritage Valley Health System Beaver

    Beaver, Pennsylvania, 15009

  • UM Upper Chesapeake Medical Center

    Bel Air, Maryland, 21014

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Sanford Joe Lueken Cancer Center

    Bemidji, Minnesota, 56601

  • Central Vermont Medical Center/National Life Cancer Treatment

    Berlin Corners, Vermont, 05602

  • Saint Luke's University Hospital-Bethlehem Campus

    Bethlehem, Pennsylvania, 18015

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

  • 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

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Saint Luke's Cancer Institute - Boise

    Boise, Idaho, 83712

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

  • Crozer-Keystone Regional Cancer Center at Broomall

    Broomall, Pennsylvania, 19008

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • University of Vermont Medical Center

    Burlington, Vermont, 05401

  • University of Vermont and State Agricultural College

    Burlington, Vermont, 05405

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Hematology Oncology Associates of CNY at Camillus

    Camillus, New York, 13031

  • Sands Cancer Center

    Canandaigua, New York, 14424

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

  • Aultman Health Foundation

    Canton, Ohio, 44710

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Carlisle Regional Cancer Center

    Carlisle, Pennsylvania, 17015

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Physicians' Clinic of Iowa PC

    Cedar Rapids, Iowa, 52402

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Christiana Care Health System-Concord Health Center

    Chadds Ford, Pennsylvania, 19317

  • Chambersburg Hospital

    Chambersburg, Pennsylvania, 17201

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Vandalia Health/CAMC Institute for Academic Medicine

    Charleston, West Virginia, 25304

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • 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

  • Chelsea Hospital

    Chelsea, Michigan, 48118

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

  • University of Illinois

    Chicago, Illinois, 60612

  • University of Cincinnati Cancer Center-UC Medical Center

    Cincinnati, Ohio, 45219

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Providence Cancer Institute Clackamas Clinic

    Clackamas, Oregon, 97015

  • McLaren Cancer Institute-Clarkston

    Clarkston, Michigan, 48346

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Cancer Center/Fairview Hospital

    Cleveland, Ohio, 44111

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

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

    Clive, Iowa, 50325

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Centers-Penrose

    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

  • MU Health - University Hospital/Ellis Fischel Cancer Center

    Columbia, Missouri, 65212

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

  • Mount Carmel East Hospital

    Columbus, Ohio, 43213

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Mount Carmel Health Center West

    Columbus, Ohio, 43222

  • 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

  • Heartland Oncology and Hematology LLP

    Council Bluffs, Iowa, 51503

  • Methodist Jennie Edmundson Hospital

    Council Bluffs, Iowa, 51503

  • Greater Regional Medical Center

    Creston, Iowa, 50801

  • Northwest Cancer Center - Crown Point

    Crown Point, Indiana, 46307

  • Carle at The Riverfront

    Danville, Illinois, 61832

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Premier Blood and Cancer Center

    Dayton, Ohio, 45409

  • Dayton Physician LLC - Englewood

    Dayton, Ohio, 45415

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach

    Deerfield Beach, Florida, 33442

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

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

    Des Moines, Iowa, 50309

  • Broadlawns Medical Center

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • UI Health Care Mission Cancer and Blood - Laurel Clinic

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Geisinger Cancer Center Dickson City

    Dickson City, Pennsylvania, 18519

  • Saint Luke's Hospital of Duluth

    Duluth, Minnesota, 55805

  • Northwest Oncology LLC

    Dyer, Indiana, 46311

  • Hematology Oncology Associates of Central New York-East Syracuse

    East Syracuse, New York, 13057

  • Saint Luke's Hospital-Anderson Campus

    Easton, Pennsylvania, 18045

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Elmhurst Memorial Hospital

    Elmhurst, Illinois, 60126

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • Ephrata Cancer Center

    Ephrata, Pennsylvania, 17522

  • UPMC Hillman Cancer Center Erie

    Erie, Pennsylvania, 16505

  • Saint Vincent Hospital

    Erie, Pennsylvania, 16544

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Inova Schar Cancer Institute

    Fairfax, Virginia, 22031

  • Smilow Cancer Hospital Care Center-Fairfield

    Fairfield, Connecticut, 06824

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Parkland Health Center - Farmington

    Farmington, Missouri, 63640

  • Farmington Health Center

    Farmington, Utah, 84025

  • Weisberg Cancer Treatment Center

    Farmington Hills, Michigan, 48334

  • UPMC Cancer Center at UPMC Horizon

    Farrell, Pennsylvania, 16121

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • McLaren Cancer Institute-Flint

    Flint, Michigan, 48532

  • Texas Oncology-Flower Mound

    Flower Mound, Texas, 75028

  • Levine Cancer Institute - Rutherford

    Forest City, North Carolina, 28043

  • Poudre Valley Hospital

    Fort Collins, Colorado, 80524

  • Cancer Care and Hematology-Fort Collins

    Fort Collins, Colorado, 80528

  • Texas Oncology - Fort Worth Cancer Center

    Fort Worth, Texas, 76104

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Saint Luke's Cancer Institute - Fruitland

    Fruitland, Idaho, 83619

  • Gibbs Cancer Center-Gaffney

    Gaffney, South Carolina, 29341

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • Levine Cancer Institute-Gaston

    Gastonia, North Carolina, 28054

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • UM Baltimore Washington Medical Center/Tate Cancer Center

    Glen Burnie, Maryland, 21061

  • Crozer Regional Cancer Center at Brinton Lake

    Glen Mills, Pennsylvania, 19342

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • UCHealth Greeley Hospital

    Greeley, Colorado, 80631

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • UPMC Cancer Centers - Arnold Palmer Pavilion

    Greensburg, Pennsylvania, 15601

  • Miami Valley Cancer Care and Infusion

    Greenville, Ohio, 45331

  • UPMC Hillman Cancer Center in Greenville/UPMC Horizon

    Greenville, Pennsylvania, 16125

  • 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

  • Smilow Cancer Hospital Care Center at Greenwich

    Greenwich, Connecticut, 06830

  • Self Regional Healthcare

    Greenwood, South Carolina, 29646

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Smilow Cancer Hospital Care Center - Guilford

    Guilford, Connecticut, 06437

  • Smilow Cancer Hospital-Hamden Care Center

    Hamden, Connecticut, 06518

  • UPMC Pinnacle Cancer Center/Community Osteopathic Campus

    Harrisburg, Pennsylvania, 17109

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Northwest Cancer Center - Hobart

    Hobart, Indiana, 46342

  • Saint Mary Medical Center

    Hobart, Indiana, 46342

  • 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

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Hawaii Cancer Care Inc-Liliha

    Honolulu, Hawaii, 96817

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • UT MD Anderson Cancer Center

    Houston, Texas, 77030

  • UT MD Anderson - West Houston

    Houston, Texas, 77079

  • Cleveland Clinic Cancer Center Independence

    Independence, Ohio, 44131

  • IRMC Cancer Center

    Indiana, Pennsylvania, 15701

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

    Irvine, California, 92612

  • Jefferson Hospital

    Jefferson Hills, Pennsylvania, 15025

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

    Jonesboro, Arkansas, 72401

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Beacon Kalamazoo

    Kalamazoo, Michigan, 49048

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Karmanos Cancer Institute at McLaren Greater Lansing

    Lansing, Michigan, 48910

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

  • McLaren Cancer Institute-Lapeer Region

    Lapeer, Michigan, 48446

  • 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

  • Geisinger Medical Oncology-Lewisburg

    Lewisburg, Pennsylvania, 17837

  • CommonSpirit Saint Joseph Medical Center - East Lexington

    Lexington, Kentucky, 40509

  • Wilcox Memorial Hospital and Kauai Medical Clinic

    Lihue, Hawaii, 96766

  • Atrium Health Lincoln/LCI-Lincolnton

    Lincolnton, North Carolina, 28092

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • 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

  • UofL Health Medical Center Northeast

    Louisville, Kentucky, 40245

  • Medical Center of the Rockies

    Loveland, Colorado, 80538

  • Lowell General Hospital

    Lowell, Massachusetts, 01854

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • Cleveland Clinic Cancer Center Mansfield

    Mansfield, Ohio, 44906

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Levine Cancer Institute - Union West

    Matthews, North Carolina, 28104

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Hillcrest Hospital Cancer Center

    Mayfield Heights, Ohio, 44124

  • Texas Oncology-McKinney

    McKinney, Texas, 75071

  • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion

    Mechanicsburg, Pennsylvania, 17050

  • Riddle Memorial Hospital

    Media, Pennsylvania, 19063

  • Baptist Memorial Hospital and Cancer Center-Memphis

    Memphis, Tennessee, 38120

  • Froedtert Menomonee Falls Hospital

    Menomonee Falls, Wisconsin, 53051

  • Saint Luke's Cancer Institute - Meridian

    Meridian, Idaho, 83642

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140

  • MyMichigan Medical Center Midland

    Midland, Michigan, 48670

  • Beebe South Coastal Health Campus

    Millville, Delaware, 19967

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin, 54548

  • Atrium Health Union/LCI-Union

    Monroe, North Carolina, 28112

  • Forbes Hospital

    Monroeville, Pennsylvania, 15146

  • UPMC Cancer Center - Monroeville

    Monroeville, Pennsylvania, 15146

  • UPMC Hillman Cancer Center - Monroeville

    Monroeville, Pennsylvania, 15146

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506

  • McLaren Cancer Institute-Macomb

    Mount Clemens, Michigan, 48043

  • The Community Hospital

    Munster, Indiana, 46321

  • Women's Diagnostic Center - Munster

    Munster, Indiana, 46321

  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho, 83687

  • Saint Luke's Cancer Institute - Nampa

    Nampa, Idaho, 83687

  • Edward Hospital/Cancer Center

    Naperville, Illinois, 60540

  • Allegheny Valley Hospital

    Natrona Heights, Pennsylvania, 15065

  • Baptist Health Floyd

    New Albany, Indiana, 47150

  • UPMC Hillman Cancer Center - New Castle

    New Castle, Pennsylvania, 16105

  • Yale University

    New Haven, Connecticut, 06520

  • Mount Sinai Chelsea

    New York, New York, 10011

  • Mount Sinai West

    New York, New York, 10019

  • Mount Sinai Hospital

    New York, New York, 10029

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

  • CTCA at Southeastern Regional Medical Center

    Newnan, Georgia, 30265

  • Yale-New Haven Hospital North Haven Medical Center

    North Haven, Connecticut, 06473

  • Henry Ford Health Providence Novi Hospital

    Novi, Michigan, 48374

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269

  • HSHS Saint Elizabeth's Hospital

    O'Fallon, Illinois, 62269

  • Drexel Town Square Health Center

    Oak Creek, Wisconsin, 53154

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Mercy Hospital Oklahoma City

    Oklahoma City, Oklahoma, 73120

  • Nebraska Cancer Specialists/Oncology Hematology West PC - MECC

    Omaha, Nebraska, 68114

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Orlando Health Cancer Institute

    Orlando, Florida, 32806

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Palo Alto Medical Foundation Health Care

    Palo Alto, California, 94301

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

  • Capital Health Medical Center-Hopewell

    Pennington, New Jersey, 08534

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • McLaren Cancer Institute-Northern Michigan

    Petoskey, Michigan, 49770

  • University of Pennsylvania/Abramson Cancer Center

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Jefferson Torresdale Hospital

    Philadelphia, Pennsylvania, 19114

  • Cancer Center at Saint Joseph's

    Phoenix, Arizona, 85004

  • Mayo Clinic Hospital in Arizona

    Phoenix, Arizona, 85054

  • Avera Cancer Institute at Pierre

    Pierre, South Dakota, 57501

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • UPMC-Saint Margaret

    Pittsburgh, Pennsylvania, 15215

  • West Penn Hospital

    Pittsburgh, Pennsylvania, 15224

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • UPMC-Shadyside Hospital

    Pittsburgh, Pennsylvania, 15232

  • UPMC-Passavant Hospital

    Pittsburgh, Pennsylvania, 15237

  • UPMC-Saint Clair Hospital Cancer Center

    Pittsburgh, Pennsylvania, 15243

  • Edward Hospital/Cancer Center?Plainfield

    Plainfield, Illinois, 60585

  • Texas Oncology-Plano West

    Plano, Texas, 75093

  • McLaren-Port Huron

    Port Huron, Michigan, 48060

  • MaineHealth Maine Medical Center - Portland

    Portland, Maine, 04102

  • Legacy Good Samaritan Hospital and Medical Center

    Portland, Oregon, 97210

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • Saint Luke's Hospital - Upper Bucks Campus

    Quakertown, Pennsylvania, 18951

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

  • Renown Regional Medical Center

    Reno, Nevada, 89502

Other trials in United States

About this study

Official title: RAndomized Phase II/III Trial of Consolidation Radiation + Immunotherapy for ES-SCLC: RAPTOR Trial

This phase II/III trial compares the effect of adding radiation therapy to the usual maintenance therapy with atezolizumab versus atezolizumab alone in patients who have already received atezolizumab plus chemotherapy for the treatment of small cell lung cancer that has spread outside of the lung or to other parts of the body (extensive stage). 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. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy in addition to atezolizumab may extend the time without extensive small cell lung cancer growing or spreading compared to atezolizumab alone.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To compare investigator-assessed progression free survival (PFS) between atezolizumab plus radiotherapy and atezolizumab alone. (Phase II) II. To compare overall survival (OS) between atezolizumab plus radiotherapy and atezolizumab alone. (Phase III)

SECONDARY OBJECTIVES:

  1. To assess the toxicity between the atezolizumab plus radiotherapy arm and the atezolizumab arm.

II. To assess the impact of adding radiotherapy on PFS and OS in patients with 1-3 visible tumors and > 3 visible tumors.

III. To assess the impact of adding radiotherapy on PFS and OS in patients receiving consolidation radiotherapy to all visible disease ("complete consolidation") and patients who do not receive consolidation radiation to all visible disease ("incomplete consolidation").

EXPLORATORY OBJECTIVE:

  1. To assess the association between pre-treatment tumor burden (determined by central radiographic assessment, using both tumor number and tumor volume), and PFS and OS benefit.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive atezolizumab intravenously (IV) over 30 minutes +/- 10 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive atezolizumab IV over 30 minutes +/- 10 minutes. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo radiation therapy once daily (QD) on days 1-5 during weeks 1-5 only.

Patients undergo positron emission tomography and computed tomography (PET/CT) scan, computed tomography (CT), and magnetic resonance imaging (MRI) throughout the trial. Patients also undergo blood and tissue collection throughout the trial.

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

Being tested
Atezolizumab, Biospecimen Collection, Computed Tomography, Magnetic Resonance Imaging, Positron Emission Tomography

What participants receive

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

  • 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

    Undergo blood and tissue collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Magnetic Resonance ImagingProcedure or surgery

    Also called Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan

    Undergo MRI

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)

    Undergo PET

  • Radiation TherapyRadiation

    Also called Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate

    Undergo radiation therapy

Study groups in NCT04402788
Study groupRoleWhat they receive
Arm I (atezolizumab)Active comparatorPatients receive atezolizumab IV over 30 minutes +/- 10 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT scan, CT, and MRI throughout the trial. Patients also undergo blood and tissue collection throughout the trial.
Receives: Drug: Atezolizumab; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography
Arm II (atezolizumab, radiation therapy)ExperimentalPatients receive atezolizumab IV over 30 minutes +/- 10 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo radiation therapy QD on days 1-5 during weeks 1-5 only. Patients undergo PET/CT scan, CT, and MRI throughout the trial. Patients also undergo blood and tissue collection throughout the trial.
Receives: Drug: Atezolizumab; Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Radiation: Radiation Therapy

What is being measured

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

  1. Progression-free survival (PFS) (Phase II)

    Will compare the distributions of PFS between treatment arms using a one-sided stratified log-rank test in all randomized eligible patients. The rates at various timepoints (e.g., every 6 months after randomization) and medians of PFS for each arm will be estimated using the Kaplan-Meier method. The associated 95% confidence interval (CI) will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. Results from an unstratified analysis will also be provided.

    Measured: From randomization to any documented progression or death due to any cause, whichever occurs first, assessed up to 6 years

  2. Overall survival (OS) (Phase III)

    Will compare arm I to arm 2 based on OS using a stratified log-rank test. Hazard ratios will be estimated using a stratified Cox regression model. Event rates over time will be estimated within each treatment group using the Kaplan-Meier method.

    Measured: From randomization to the date of death due to any cause, assessed up to 6 years

Secondary outcomes (6)

  1. Incidence of adverse events

    For each patient, the maximum severity reported for both immune mediated and non-immune mediated adverse events will be used in the summaries. Adverse events will be summarized regardless of relationship to protocol treatment as assessed by the investigator. All adverse events, adverse events leading to withdrawal, interruption or modification of protocol treatment, grade >= 3 adverse events, and serious adverse events will be summarized. Deaths and cause of death will be summarized. The rate of treatment-related adverse events using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, version [v.]5.0) will be reported with the frequency and severity (e.g., type, grade, and attribution) by arm, the analysis will be performed at the time of both phase II and phase III (if applicable) primary endpoint analyses. All adverse events will be classified as either immune or non-immune mediated.

    Measured: Up to 6 years

  2. PFS (Phase III)

    Assessed per Response Evaluation Criteria in Solid Tumors (RECIST). Will compare the distributions of PFS between treatment arms using a one-sided stratified log-rank test in all randomized eligible patients at 0.025 level. The rates at various timepoints (e.g., every 6 months after randomization) and medians of PFS for each arm will be estimated using the Kaplan-Meier method. The associated 95% CI will be calculated using Greenwood's formula and based on a log-log transformation applied on the survival function. If one stratum has less than 10 events, the stratification factor which contains the level with the smallest number of patients will be removed from the stratified analyses.

    Measured: Up to 6 years

  3. PFS in patients with 1-3 distinct visible tumors and > 3 distinct visible tumors

    Will be similarly summarized and compared between experimental and control. The interaction between the treatment groups and tumor number groups will also be explored in Cox regression model.

    Measured: Up to 6 years

  4. OS in patients with 1-3 distinct visible tumors and > 3 distinct visible tumors

    Will be similarly summarized and compared between experimental and control. The interaction between the treatment groups and tumor number groups will also be explored in Cox regression model.

    Measured: Up to 6 years

  5. PFS in patients receiving consolidation radiotherapy to all visible disease and patients who do not receive consolidation radiotherapy to all visible disease

    Measured: Up to 6 years

  6. OS in patients receiving consolidation radiotherapy to all visible disease and patients who do not receive consolidation radiotherapy to all visible disease

    Measured: Up to 6 years

Timeline

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

  1. First posted27 May 2020
  2. Study start7 Jan 2021
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Apr 2027 (estimated)

Why it stopped: Scheduled Interim Monitoring

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
138 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04402788
Sponsor's protocol ID
NCI-2020-03472
Other IDs
NCI-2020-03472, NRG-LU007, NRG-LU007, U10CA180868
Status last verified
Sep 2026
First submitted
22 May 2020
Last updated
29 Oct 2026
Results posted
No
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

  • Ganti AKP, Loo BW Jr, Badiyan S, Bassetti M, Bestvina C, Chiang A, Choudhury N, D'Avella CA, Daly M, Dowlati A, Edelman M, Florsheim C, Gold KA, Goldman JW, Grecula JC, Hann C, Khalil M, Lee R, Malhotra J, Merritt RE, Mohindra N, Molina JR, Moran C, Mulvey C, Osmundson EC, Patel S, Patil T, Pokharel S, Puri S, Qin A, Sands J, Shields M, Tailor TD, Waqar SN, Cassara CJ, Ramakrishnan S. NCCN Guidelines(R) Insights: Small Cell Lung Cancer, Version 2.2026. J Natl Compr Canc Netw. 2026 Jan;24(1):e260002. doi: 10.6004/jnccn.2026.0002.

    PubMed 41671459

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Atezolizumab, Biospecimen Collection and Computed Tomography in people with Extensive Stage Lung Small Cell Carcinoma, run by National Cancer Institute (NCI) at 411 sites in United States.

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 26 inclusion and 23 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: paused, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 411 sites in United States. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Results are not available in the source record.

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?

Progression-free survival (PFS) (Phase II) (time frame: From randomization to any documented progression or death due to any cause, whichever occurs first, assessed up to 6 years). 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 NCT04402788, which also lists 1 linked publication.

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 29 Oct 2026.

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