2022 World Conference on Lung Cancer (ePosters)-EP14.05-004. Temozolomide and Atezolizumab as Second Line Treatment for Extensive Stage Small Cell Lung Cancer: A Randomized, Multi-Cohort Phase 2 Trial

EP14.05-004. Temozolomide and Atezolizumab as Second Line Treatment for Extensive Stage Small Cell Lung Cancer: A Randomized, Multi-Cohort Phase 2 Trial

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A randomized, multi-cohort Phase 2 trial is currently underway to study the efficacy of Temozolomide (TMZ) and Atezolizumab as second-line treatment for patients with extensive stage small cell lung cancer (ES-SCLC) who have experienced progression after first-line chemo-immunotherapy. The trial aims to determine the objective response rate of patients treated with two different dosing regimens of TMZ after first-line treatment. TMZ has been found to be active in ES-SCLC and has shown immunomodulatory effects on myeloid derived suppressor cells (MDSCs) and regulatory T cells (Tregs). The combination of TMZ and immune checkpoint inhibitors (ICI) has also shown activity in patients with neuroendocrine neoplasms and SCLC.<br /><br />The trial is open-label and consists of two cohorts. Cohort 1 receives TMZ 150 mg/m2 for days 1-5, while Cohort 2 receives TMZ 75 mg/m2 for days 1-21, both in 28-day cycles. Patients in each cohort will be randomized and stratified based on the presence of brain metastases and platinum sensitive/resistant disease. The primary endpoint is disease response rate, and secondary endpoints include progression-free survival (PFS), overall survival (OS), safety, and tolerability. Exploratory analyses will evaluate changes in immune subsets induced by the different dosing of TMZ. The trial requires 28 evaluable patients in each cohort.<br /><br />Correlative studies will be conducted to assess peripheral blood immune cells and evaluate changes in immune subsets, including MDSCs and Tregs, using mass cytometry. The gut microbiome will also be evaluated for microbial diversity. The trial is supported by Genentech, Inc. and is currently enrolling patients at The Ohio State University Comprehensive Cancer Center. It will soon be opening at other sites in the Big 10 Cancer Research Consortium.<br /><br />Overall, this Phase 2 trial aims to assess the efficacy of atezolizumab and two different dosing regimens of TMZ as second-line therapy for refractory/recurrent ES-SCLC. The results of this trial will provide valuable insights into the treatment options for patients with limited treatment options after first-line chemo-immunotherapy.

Asset Subtitle

Dwight H Owen

Meta Tag

Speaker Dwight H Owen

Topic Small Cell Lung Cancer and Neuro-endocrine Tumours - RW/SOC

Keywords

Phase 2 trial

Temozolomide

Atezolizumab

second-line treatment

extensive stage small cell lung cancer

chemo-immunotherapy

dosing regimens

immune subsets

mass cytometry

refractory