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Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III randomized study of chemoradiation versus chemoradiation plus Atezolizumab
This phase II/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.
Primary Objective Phase II: To compare progression free survival (PFS) for patients with limited stage small cell lung cancer (LS-SCLC) treated with chemoradiation +/- atezolizumab. Phase III: To compare overall survival (OS) for patients with LS-SCLC treated with chemoradiation +/- atezolizumab. Secondary Objectives To compare progression free survival (PFS) for patients with limited stage small cell lung cancer (LS-SCLC) treated with chemoradiation +/- atezolizumab. (phase III) To determine overall response rate (ORR), rates of local control, and distant metastases free survival with chemoradiation +/- atezolizumab To characterize immune mediated and non-immune mediated toxicity from chemoradiotherapy plus atezolizumab To compare quality of life, as measured by the FACT-TOI, for patients undergoing chemoradiation +/- atezolizumab To evaluate the quality-adjusted survival, using scores from the EQ-5D-5L, of chemoradiation +/- atezolizumab for patients with LS-SCLC To characterize fatigue, as measured by the PROMIS, following chemoradiation +/- atezolizumab To determine the association of blood based tumor mutational burden (bTMB) and tissue-based tumor mutational burden (tTMB) with clinical outcome
Atezolizumab (Tecentriq); Paraplatin (carboplatin); Radiotherapy (); carboplatin (); cisplatin (); etoposide ()