A Randomized, Multi-Cohort Phase II Trial of Temozolomide and Atezolizumab for Subsequent Line Treatment for Small Cell Lung Cancer
Dwight Owen
Summary
This phase II trial studies the effects of temozolomide and atezolizumab as second or third line treatment for patients with small cell lung cancer that has spread to other places in the body (metastatic) or has come back (recurrent). Chemotherapy drugs, such as temozolomide, 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. 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 temozolomide and atezolizumab as second or third line treatment may help prolong survival in patients with small cell lung cancer.
Description
PRIMARY OBJECTIVE: I. To estimate the efficacy of atezolizumab and temozolomide in two dosing schedules for patients with metastatic small-cell lung cancer (SCLC) who progress after chemoimmunotherapy. SECONDARY OBJECTIVES: I. To evaluate the safety profile and toxicity of combination atezolizumab and temozolomide in two dosing schedules as per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. II. To evaluate the progression free survival (PFS) and overall survival (OS) of patients treated with combination atezolizumab and temozolomide. III. To evaluate the intracran…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information * NOTE: HIPAA authorization may be included in the informed consent or obtained separately * Age \>= 18 years at the time of consent * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 2 within 28 days prior to registration * Have histologically or cytologically-documented diagnosis of extensive stage (i.e. metastatic and/or recurrent) small cell lung cancer and have progressed or recurred after platinum-b…
Interventions
- BiologicalAtezolizumab
Given IV
- DrugTemozolomide
Given PO
Locations (5)
- University of Illinois Cancer CenterChicago, Illinois
- Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolis, Indiana
- University of Iowa Hospitals and ClinicsIowa City, Iowa
- Ohio State University Comprehensive Cancer CenterColumbus, Ohio
- University of WisconsinMadison, Wisconsin