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RecruitingPhase 2NCT04919382

Temozolomide and Atezolizumab for Subsequent Line for the Treatment of Metastatic or Recurrent Small Cell Lung Cancer

Trial Parameters

ConditionExtensive Stage Lung Small Cell Carcinoma
SponsorDwight Owen
Study TypeINTERVENTIONAL
PhasePhase 2
Enrollment56
SexALL
Min Age18 Years
Max AgeN/A
Start Date2022-01-26
Completion2026-12-31
Interventions
AtezolizumabTemozolomide

Eligibility Fast-Check

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Brief 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.

Eligibility Criteria

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-based chemotherapy with immunotherapy. Eligible patients will be defined as follows: * "Sensitive" Disease: Patients who had one previous line of chemotherapy and relapsed after \> 90 days of completion of treatment * "Resistant" Disease: Patients with no response to first-line chemo-immunotherapy or progression \< 90 days after completing treatment * Measurable disease according to Response Evaluation

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