RecruitingPhase 2Phase 3NCT04093167

Study of CTDNA Response Adaptive Immuno-Chemotherapy in Lung Cancer

A Biomarker-Directed, Multi-Centre Phase II/III Study of CTDNA Response Adaptive Immuno-Chemotherapy in Lung Cancer


Sponsor

Canadian Cancer Trials Group

Enrollment

230 participants

Start Date

May 26, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

The standard or usual treatment for this disease is pembrolizumab given by needle into the veins (IV). Some cancers shed DNA (circulating tumour DNA or ctDNA) or genes (biomarkers) into the blood, and levels of these biomarkers may be able to tell researchers how people respond to treatment with pembrolizumab before they feel worse, or the cancer is worse on imaging tests. Researchers are studying how levels of these biomarkers can show how cancers are responding to treatment and whether adding chemotherapy to pembrolizumab based on detection of ctDNA can offer better results.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether patients with advanced non-small cell lung cancer (NSCLC) who have detectable cancer DNA in their blood after starting immunotherapy (pembrolizumab) would benefit from adding chemotherapy to their treatment. The study uses a blood test called ctDNA (circulating tumor DNA) to guide treatment decisions. **You may be eligible if...** - You are 18 or older - You have advanced or metastatic NSCLC with a PD-L1 score of 50% or higher (meaning your cancer is more likely to respond to immunotherapy) - Your cancer does NOT have EGFR or ALK mutations - You have recently started pembrolizumab (immunotherapy) as your first cancer treatment - You have detectable cancer DNA in your blood at 6 weeks into immunotherapy **You may NOT be eligible if...** - You have symptomatic brain metastases requiring high-dose steroids - You have an autoimmune condition requiring immunosuppressive drugs - You are pregnant or breastfeeding - You are receiving another cancer treatment at the same time 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

DRUGPembrolizumab

Per current Product Monograph/U.S. Drug Label and/or local guidelines.


Locations(10)

The University of Chicago Medical Center

Chicago, Illinois, United States

The Sidney Kimmel Comprehensive Cancer Centre

Baltimore, Maryland, United States

BCCA - Vancouver

Vancouver, British Columbia, Canada

Health Sciences North

Greater Sudbury, Ontario, Canada

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, Canada

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Algoma District Cancer Program

Sault Ste. Marie, Ontario, Canada

University Health Network

Toronto, Ontario, Canada

The Jewish General Hospital

Montreal, Quebec, Canada

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04093167


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