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RAndomized Phase II/III Trial Of Consolidation Radiation + Immuno-therapy for ES-SCLC (PSCI# 20-118) (NRG-LU007)
The purpose of this study is to compare the usual treatment of the immune therapy drug atezolizumab alone, to using radiation therapy plus the usual treatment. The addition of radiation to the usual treatment could shrink your cancer or prevent it from returning. This study will help the study doctors find out if this different approach is better, the same or worse than the usual approach. To decide if it is better, the study doctors will be looking to see if the study approach increases the life of patients or extends your time without disease compared to the usual approach.
The purpose of this study is to compare the usual treatment of the immune therapy drug atezolizumab alone, to using radiation therapy plus the usual treatment.
Yes
Medicine: Hematology and Medical Oncology (HERSHEY)
All
18 year(s) or older
NCT04402788
SITE00000901
Inclusion Criteria:
Pathologically proven diagnosis of extensive stage small cell lung cancermeasurable disease (per RECIST) and 3 or fewer observable liver metastases and no evidence of progressive disease at enrollment
Patients presenting with a pleural effusion will be eligible if thoracentesis is cytologically negative and non-bloody
ECOG Performance Status of 0-2 at the time of registration
Age ≥ 18
Exclusion Criteria:
Metastatic disease invading the liver (>3 metastases), heart or >10 metastatic sitesPrior invasive malignancy (except non-melanomatous skin cancer) unless disease free for 5 years prior to randomization
Chronic obstructive pulmonary disease (COPD) requiring chronic oral steroid therapy of > 10 mg prednisone daily or equivalent at the time of registration
Patients who have had immunotherapy-induced pneumonitis
History of recent myocardial infarction within 6 months prior to registration
Cancer