Actively Recruiting
A Randomized Phase II Trial of Temozolomide and Atezolizumab for Metastatic or Recurrent Small Cell Lung Cancer
Led by Dwight Owen · Updated on 2026-04-08
56
Participants Needed
5
Research Sites
52 weeks
Total Duration
On this page
Sponsors
D
Dwight Owen
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of temozolomide and atezolizumab as second or third line treatments for patients with metastatic or recurrent small cell lung cancer. This phase II trial aims to estimate the effectiveness of these drugs given in two different dosing schedules for patients whose cancer has progressed after chemoimmunotherapy. The study also explores safety, progression-free survival, overall survival, and biological markers related to treatment response. Participants are randomly assigned to one of two groups. In the first group, patients receive atezolizumab intravenously on day 1 and temozolomide orally once daily on days 1 to 5 of each 28-day cycle. In the second group, patients receive atezolizumab intravenously on day 1 and temozolomide orally once daily on days 1 to 14 during the first cycle and days 1 to 21 in following cycles. Treatment continues until disease progression or unacceptable side effects occur. After treatment ends, patients have a follow-up visit 30 days later and then every three months. During the study, participants undergo regular assessments including tumor measurements using RECIST criteria, safety monitoring for side effects, and blood tests to study immune cells and protein changes. The main outcome measured is the objective response rate over up to two years. Secondary outcomes include adverse events, progression-free survival, intracranial progression-free survival at six months, and overall survival. Participants provide archival tumor tissue and peripheral blood samples at specific times to help understand treatment effects.
CONDITIONS
Brief Title
Temozolomide and Atezolizumab for Subsequent Line for the Treatment of Metastatic or Recurrent Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent and HIPAA authorization for personal health information release
- Age 18 years or older at consent
- ECOG performance status of 0 to 2 within 28 days prior to registration
- Histologically or cytologically confirmed metastatic or recurrent small cell lung cancer progressed after platinum-based chemoimmunotherapy
- Measurable disease by RECIST v1.1 within 28 days prior to registration
- Maximum of 3 prior lines of systemic therapy for metastatic disease
- Adequate blood counts and organ function within 28 days prior to registration
- Negative pregnancy test for females of childbearing potential within 14 days prior to registration
- Agreement to use contraception or abstain during treatment and specified periods after
- Ability to understand and comply with study procedures
- Availability of archival tumor tissue preferably obtained within 1 year
- Willingness to provide peripheral blood samples during the study
- Life expectancy greater than 3 months
- Ability to swallow and retain oral medication
You will not qualify if you...
- Current participation or recent use of investigational agents within 4 weeks prior to treatment
- Prior temozolomide therapy
- Prior or concurrent malignancy interfering with trial assessment
- Symptomatic or untreated CNS metastases or progressing brain metastases
- Active infection requiring systemic therapy including tuberculosis, hepatitis B, hepatitis C, or HIV unless controlled
- Recent chemotherapy, immunotherapy, targeted therapy, or radiation within 2 weeks prior to treatment or unresolved adverse events
- Active or history of autoimmune or immune deficiency diseases except controlled conditions
- History of lung diseases such as idiopathic pulmonary fibrosis or pneumonitis
- Significant cardiovascular disease within 3 months prior to treatment
- Psychiatric or substance abuse disorders interfering with trial participation
- Recent live vaccine within 4 weeks prior to treatment
- Pregnant or breastfeeding
- Severe allergies to study drug components
- Uncontrolled fluid accumulations requiring frequent drainage
- Uncontrolled or symptomatic hypercalcemia
- History of leptomeningeal disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Repeated 28-day cycles until disease progression or unacceptable toxicity
Participants receive treatment with atezolizumab intravenously on day 1 and temozolomide orally in one of two dosing schedules, repeated every 28 days in the absence of disease progression or unacceptable toxicity.
1 visit per 28-day cycle (in-person)
Duration - 30 days and every 3 months thereafter
After completion of study treatment, participants are followed up to monitor their health and survival.
Visits at 30 days post treatment and every 3 months afterward
Trial Site Locations
Total: 5 locations
1
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612
Actively Recruiting
2
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
3
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
4
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
5
University of Wisconsin
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
D
Dwight Owen
A
Amber Ryba
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here