Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT03811002

PHASE3

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)

Sponsor: National Cancer Institute (NCI)

View on ClinicalTrials.gov

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. 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

544

Start Date

2019-07-26

Completion Date

2029-02-21

Last Updated

2026-04-09

Healthy Volunteers

Conditions

Limited Stage Lung Small Cell Carcinoma Stage I Lung Cancer AJCC v8 Stage II Lung Cancer AJCC v8 Stage III Lung Cancer AJCC v8

Interventions

RADIATION

3-Dimensional Conformal Radiation Therapy

Undergo 3D-CRT

DRUG

Atezolizumab

Given IV

PROCEDURE

Biospecimen Collection

Correlative studies

DRUG

Carboplatin

Given IV

DRUG

Cisplatin

Given IV

DRUG

Etoposide

Given IV

RADIATION

Intensity-Modulated Radiation Therapy

Undergo IMRT

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Inclusion Criteria: * 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 * 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 Exclusion Criteria: * 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) * 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.

Locations (543)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

CTCA at Western Regional Medical Center

Goodyear, Arizona, United States

Banner University Medical Center - Tucson

Tucson, Arizona, United States

University of Arizona Cancer Center-North Campus

Tucson, Arizona, United States

NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro

Jonesboro, Arkansas, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Sutter Auburn Faith Hospital

Auburn, California, United States

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Los Angeles General Medical Center

Los Angeles, California, United States

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States

Memorial Medical Center

Modesto, California, United States

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Sutter Roseville Medical Center

Roseville, California, United States

Sutter Medical Center Sacramento

Sacramento, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

California Pacific Medical Center-Pacific Campus

San Francisco, California, United States

Gene Upshaw Memorial Tahoe Forest Cancer Center

Truckee, California, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

UCHealth Memorial Hospital Central

Colorado Springs, Colorado, United States

Memorial Hospital North

Colorado Springs, Colorado, United States

AdventHealth Porter

Denver, Colorado, United States

Poudre Valley Hospital

Fort Collins, Colorado, United States

Cancer Care and Hematology-Fort Collins

Fort Collins, Colorado, United States

UCHealth Greeley Hospital

Greeley, Colorado, United States

AdventHealth Littleton

Littleton, Colorado, United States

Medical Center of the Rockies

Loveland, Colorado, United States

AdventHealth Parker

Parker, Colorado, United States

Beebe South Coastal Health Campus

Millville, Delaware, United States

Helen F Graham Cancer Center

Newark, Delaware, United States

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Beebe Health Campus

Rehoboth Beach, Delaware, United States

GenesisCare USA - Aventura FP

Aventura, Florida, United States

GenesisCare USA - Aventura

Aventura, Florida, United States

Boca Raton Regional Hospital

Boca Raton, Florida, United States

UM Sylvester Comprehensive Cancer Center at Coral Gables

Coral Gables, Florida, United States

UM Sylvester Comprehensive Cancer Center at Deerfield Beach

Deerfield Beach, Florida, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

Lee Memorial Health System

Fort Myers, Florida, United States

Regional Cancer Center-Lee Memorial Health System

Fort Myers, Florida, United States

UF Health Cancer Institute - Gainesville

Gainesville, Florida, United States

The Watson Clinic

Lakeland, Florida, United States

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Miami Cancer Institute

Miami, Florida, United States

Orlando Health Cancer Institute

Orlando, Florida, United States

Sacred Heart Hospital

Pensacola, Florida, United States

UM Sylvester Comprehensive Cancer Center at Plantation

Plantation, Florida, United States

Moffitt Cancer Center

Tampa, Florida, United States

Grady Health System

Atlanta, Georgia, United States

Emory University Hospital Midtown

Atlanta, Georgia, United States

Piedmont Hospital

Atlanta, Georgia, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Emory Saint Joseph's Hospital

Atlanta, Georgia, United States

Piedmont Fayette Hospital

Fayetteville, Georgia, United States

CTCA at Southeastern Regional Medical Center

Newnan, Georgia, United States

Piedmont Newnan Hospital

Newnan, Georgia, United States

Memorial Health University Medical Center

Savannah, Georgia, United States

Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

Savannah, Georgia, United States

Hawaii Cancer Care Inc - Waterfront Plaza