Actively Recruiting
Temozolomide and Atezolizumab for Subsequent Line for the Treatment of Metastatic or Recurrent Small Cell Lung Cancer
Led by Dwight Owen · Updated on 2026-04-08
56
Participants Needed
5
Research Sites
361 weeks
Total Duration
On this page
Sponsors
D
Dwight Owen
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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...
- Provide written informed consent and HIPAA authorization
- Be 18 years of age or older at consent
- Have ECOG performance status of 0 to 2 within 28 days before registration
- Have histologically or cytologically confirmed extensive stage (metastatic or recurrent) small cell lung cancer that progressed after platinum-based chemoimmunotherapy
- Have measurable disease based on RECIST v1.1 within 28 days before registration
- Have had no more than 3 prior lines of systemic therapy for metastatic disease
- Have absolute neutrophil count (ANC) at least 1.5 K/mm3 within 28 days before registration
- Have platelets at least 100,000/mcL within 28 days before registration
- Have serum creatinine ≤ 2.0 times upper limit of normal or creatinine clearance ≥ 50 mL/min within 28 days before registration
- Have bilirubin ≤ 1.5 times upper limit of normal or direct bilirubin ≤ upper limit of normal if total bilirubin > 1.5 times normal
- Have AST and ALT ≤ 3 times upper limit of normal or ≤ 5 times with liver metastases within 28 days before registration
- Have albumin > 2.5 g/dL within 28 days before registration
- Have INR or PT ≤ 1.5 times upper limit of normal if not on therapeutic anticoagulation, or stable anticoagulant regimen if on therapy
- Have aPTT ≤ 1.5 times upper limit of normal if not on therapeutic anticoagulation, or stable anticoagulant regimen if on therapy
- Female participants of childbearing potential must have negative pregnancy test within 14 days before registration
- Agree to remain abstinent or use effective contraception during treatment and for specified months after last dose (women for 5 months, men for 3 months)
- Be able to understand and comply with study procedures
- Provide archival tumor tissue preferably obtained within 1 year before screening, or deemed eligible without it
- Be willing to provide peripheral blood samples during the study
- Have life expectancy greater than 3 months
- Be able to swallow and retain oral medication
You will not qualify if you...
- Currently participating in another investigational study or received investigational therapy or device within 4 weeks before starting treatment
- Have received prior temozolomide therapy
- Have prior or concurrent malignancy that may interfere with safety or efficacy assessments
- Have symptomatic, untreated, or actively progressing central nervous system metastases
- Have clinically significant acute infections including active tuberculosis, hepatitis B or C, or uncontrolled HIV
- Have received chemotherapy, immunotherapy, targeted therapy, or radiation within 2 weeks before study day 1 or have not recovered from side effects
- Have active or history of autoimmune disease or immune deficiency with some exceptions for controlled conditions
- Have history of certain lung diseases like idiopathic pulmonary fibrosis or active pneumonitis
- Have significant cardiovascular disease within 3 months prior to treatment
- Have psychiatric or substance abuse disorders interfering with study participation
- Have received live attenuated vaccines within 4 weeks prior to treatment
- Are pregnant or breastfeeding
- Have history of severe allergic reactions to antibodies or components of atezolizumab
- Have uncontrolled pleural, pericardial effusions, or ascites needing frequent drainage
- Have uncontrolled or symptomatic high calcium levels
- Have history of leptomeningeal disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
A
Amber Ryba
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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