NCT04919382 · Dwight Owen
Temozolomide and Atezolizumab as Second or Third Line for the Treatment of Metastatic or Recurrent Small Cell Lung Cancer
What this study 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).
View original scientific description
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.
Interventions
BIOLOGICAL
Atezolizumab
Given IV
DRUG
Temozolomide
Given PO
Primary outcome measures
Investigator-assessed objective response rate (ORR)
Time frame: Up to 2 years
Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Response will be defined by a confirmed complete response (CR) or confirmed partial response (PR). Response will be defined for patients with measurable disease and who receive at least one dose of combination treatment. ORR rate will be calculated as the proportion of patients with RECIST-based PR or CR divided by the total number of evaluable patients. Exact binomial 90% and 95% confidence intervals for the true PR+CR response rate will be calculated.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 E
Where
- Chicago, Illinois
- Indianapolis, Indiana
- Iowa City, Iowa
- Columbus, Ohio
- Madison, Wisconsin
Collaborators
Genentech, Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 8, 2026 · Source of record for eligibility and locations