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)

Recruitment & Eligibility

Status: Active, not recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

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 stero

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)

Secondary Outcome Measures

Name	Time	Method
Progression free survival (PFS);Incidence of adverse events;Objective response rate (ORR);Time to progression;Distant metastases-free survival (DMFS);Quality of life (QoL);Quality-adjusted survival;Level of fatigue;Molecular subtyping