Title: A randomized, multi-cohort phase II trial of temozolomide and atezolizumab as second or third line treatment for small cell lung cancer
Principal Investigator: Dwight Owen, MD, of Ohio State University Comprehensive Cancer Center in Columbus
Description: Researchers are conducting a phase 2 study to evaluate atezolizumab and temozolomide in patients with extensive-stage small cell lung cancer (ES-SCLC) that progressed after chemoimmunotherapy.
Patients will receive 1 of 2 dosing regimens. In cohort 1, patients will receive atezolizumab intravenously over 30-60 minutes on day 1 and temozolomide orally once daily on days 1-5 of each 28-day cycle.
In cohort 2, patients will receive atezolizumab intravenously over 30-60 minutes on day 1. They will also receive temozolomide orally once daily on days 1-14 of cycle 1, and then on days 1-21 of subsequent cycles.
The primary outcome is the investigator-assessed objective response rate. Secondary outcomes include treatment-related adverse events, progression-free survival, intracranial progression-free survival, and overall survival.
To be eligible for this study, patients must be 18 years of age or older. They must have ES-SCLC that has progressed or recurred after platinum-based chemotherapy and immunotherapy. Patients must not have received more than 2 prior lines of systemic therapy in the metastatic setting. For a complete list of eligibility criteria, please see the reference.
This study is sponsored by Dwight Owen in collaboration with Genentech, Inc.
ClinicalTrials.gov. Temozolomide and atezolizumab as second or third line for the treatment of metastatic or recurrent small cell lung cancer. NCT04919382. Accessed May 21, 2023.