Study on Reduced Chemotherapy and Immunotherapy for Older Adults with Advanced Non-Small Cell Lung Cancer
Sponsor: Virginia Commonwealth University
ClinicalTrials ID:NCT06731413
This clinical trial is testing a combination of lower-dose chemotherapy and immunotherapy as a first treatment option for older adults with advanced non-small cell lung cancer (NSCLC) that has a PD-L1 score of less than 50%. The study aims to see how often side effects lead to stopping chemotherapy.
Patient Parameters
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Program Overview
The purpose of this study is to evaluate the safety and tolerability of a reduced dose of chemotherapy combined with immunotherapy in older adults (aged 70 and above) with advanced non-small cell lung cancer (NSCLC) that has returned or spread. The study focuses on patients whose cancer does not have certain genetic mutations that can be targeted by specific drugs and who have a PD-L1 score of less than 50%.
Description
This study is being conducted at a single institution and involves a single group of participants. It is an open-label phase 2 trial, meaning all participants will receive the same treatment, and both the researchers and participants know what treatment is being given. The study is designed for older adults (aged 70 and above) or those who meet certain frailty criteria, who have advanced or recurrent non-small cell lung cancer (NSCLC) without specific genetic mutations. The goal is to assess the safety and tolerability of a reduced dose of chemotherapy combined with immunotherapy. Participants will be monitored for any side effects that may lead to stopping chemotherapy.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with non-small cell lung cancer (NSCLC), either squamous or non-squamous type.
- Have advanced (Stage IV) or recurrent cancer that cannot be treated with curative methods like combined chemo-radiation.
- Have not received any previous treatment for advanced or recurrent cancer, except for treatments given more than 6 months before joining the study.
- Aged 70 or older, or meet certain frailty criteria.
- Cancer does not have specific genetic mutations that can be treated with FDA-approved targeted therapies.
- PD-L1 tumor proportion score (TPS) is less than 50%.
- Have a performance status score of 0 to 3, indicating varying levels of activity and ability to care for oneself.
- Have measurable cancer based on standard criteria.
- Have adequate blood cell counts and liver function as determined by specific tests.
- Able to understand and willing to sign a consent form to participate in the study.
Exclusion Criteria
- Life expectancy of less than 3 months.
- Have an active autoimmune disease that required treatment in the past 2 years.
- Diagnosed with interstitial lung disease.
- Have poor kidney function with creatinine clearance less than 30 mL/min.
- Have untreated or symptomatic cancer that has spread to the brain or spinal cord, unless it is asymptomatic or treated.
- Require ongoing use of immunosuppressive medications, except for certain low-dose or short-term steroids, or specific types of inhaled or topical steroids.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Virginia Commonwealth University | 23298 | Richmond | Virginia |
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