NCT04919382

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

A Randomized, Multi-Cohort Phase II Trial of Temozolomide and Atezolizumab for Subsequent Line Treatment for Small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 56 (estimated)
• Sponsor: Dwight Owen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 intracranial PFS rate at 6 months (icPFS6) of patients with SCLC treated with atezolizumab and temozolomide. CORRELATIVE/EXPLORATORY OBJECTIVES: I. Explore association of myeloid-derived suppressor cell (MDSC) levels at baseline biomarker status from tumor biopsy samples and peripheral blood and correlate these with clinical parameters (including overall response rate \[ORR\], OS and toxicity). II. To evaluate changes in MDSC induced by different dosing of temozolomide. III. To explore post-translational modifications of PD-L1 by mass spectrometry. OUTLINE: Patients are randomized to 1 of 2 cohorts. COHORT I: Patients receive atezolizumab intravenously (IV) over 30-60 minutes on day 1 and temozolomide orally (PO) once daily (QD) on days 1-5. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. COHORT II: Patients receive atezolizumab IV over 30-60 minutes on day 1. Patients also receive temozolomide PO QD on days 1-14 of cycle 1 and days 1-21 of subsequent cycles. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up at 30 days and every 3 months thereafter.

Conditions

• Extensive Stage Lung Small Cell Carcinoma
• Metastatic Lung Small Cell Carcinoma
• Recurrent Lung Small Cell Carcinoma
• Stage IV Lung Cancer AJCC v8
• Stage IVA Lung Cancer AJCC v8
• Stage IVB Lung Cancer AJCC v8

Interventions

Type	Name	Description
BIOLOGICAL	Atezolizumab	Given IV
DRUG	Temozolomide	Given PO

Timeline

• Start date: 2022-01-26
• Primary completion: 2027-12-30
• Completion: 2028-12-30
• First posted: 2021-06-09
• Last updated: 2026-04-08

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study