RecruitingPhase 2NCT04919382

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


Sponsor

Dwight Owen

Enrollment

56 participants

Start Date

Jan 26, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of temozolomide (a chemotherapy tablet) and atezolizumab (an immunotherapy drug) for people with small cell lung cancer that has spread and returned after previous treatment with chemotherapy and immunotherapy. **You may be eligible if:** - You are 18 or older with advanced or metastatic small cell lung cancer - Your cancer has progressed after platinum-based chemotherapy combined with immunotherapy - You have had no more than 3 prior lines of treatment - You have measurable cancer visible on imaging - Your blood counts, kidney, liver, and heart function are within acceptable ranges - You can swallow tablets **You may NOT be eligible if:** - You have received temozolomide before - Your cancer has spread to your brain and is causing symptoms - You have active autoimmune disease (like rheumatoid arthritis or inflammatory bowel disease) - You have active hepatitis B, hepatitis C, or HIV infection - You are pregnant or breastfeeding - You have a history of severe lung inflammation (interstitial lung disease) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAtezolizumab

Given IV

DRUGTemozolomide

Given PO


Locations(5)

University of Illinois Cancer Center

Chicago, Illinois, United States

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

University of Wisconsin

Madison, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT04919382


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