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Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab
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
Exploratory Objectives
To collect biospecimens at baseline and multiple timepoints throughout treatment and follow up, to allow for future analyses
To characterize patient-reported symptomatic toxicities measured by the PRO-CTCAE
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
Exploratory Objectives
To collect biospecimens at baseline and multiple timepoints throughout treatment and follow up, to allow for future analyses
To characterize patient-reported symptomatic toxicities measured by the PRO-CTCAE
Recruitment Status
Past Studies