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.
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
Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment
Has received prior temozolomide therapy
Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are not eligible for this trial
Symptomatic central nervous system (CNS) metastases or untreated or actively progressing CNS metastases. Subjects with asymptomatic CNS metastases (treated or untreated) will be eligible provided all of the following criteria are met.
Parallel
Atezolizumab
Biological/VaccineGiven IV
Temozolomide
DrugGiven PO
Investigator-assessed objective response rate (ORR)
Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Response will be defined by a confirmed complete response (CR) or confirmed partial response (PR). Response will be defined for patients with measurable disease and who receive at least one dose of combination treatment. ORR rate will be calculated as the proportion of patients with RECIST-based PR or CR divided by the total number of evaluable patients. Exact binomial 90% and 95% confidence intervals for the true PR+CR response rate will be calculated.
Treatment related adverse events
Defined by the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.
Progression free survival (PFS)
Will be estimated with Kaplan-Meier method. Median with 95% confidence interval will be calculated.
Intracranial PFS
Defined as the percentage of patients without intracranial disease progression (including patients with and without intracranial disease at baseline), including development of new lesions, development of symptomatic lesions or leptomeningeal disease, or intervention required for disease control (such as radiation or surgery). Will be estimated with Kaplan-Meier method. Median with 95% confidence interval will be calculated.
Overall survival
Will be estimated with Kaplan-Meier method. Median with 95% confidence interval will be calculated.
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Dwight Owen
Lead sponsor
Big Ten Cancer Research Consortium
Sponsor institution
Genentech, Inc.
Collaborator
