Study of Molecular Response Adaptive Immuno-Chemotherapy in Patients With NSCLC

Official Title

A Biomarker-Directed, Open Label, Multi-Centre Phase II Study of Molecular Response Adaptive Immuno-Chemotherapy in Patients With Non-Small Cell Lung Cancer

Summary:

The purpose of stage 1 of the study is to find out if blood tests can be used to see how the cancer is responding to treatment with pembrolizumab.

Trial Description

Primary Outcome:

• Concordance rate between molecular response and radiologic response

Secondary Outcome:

• Time to molecular response
• Correlate molecular response to RECIST response based on changes in ctDNA levels
• Correlate molecular response to progression-free survival based on changes in ctDNA levels
• Correlate molecular response to overall survival based on changes in ctDNA levels
• Explore the degree of ctDNA reduction with clinical outcomes assessed by measuring changes in ctDNA levels in plasma

The standard or usual treatment for this disease is pembrolizumab given by needle every three weeks. This study will be done in two stages. The purpose of stage 1 of the study is to find out if we can use blood tests to see how the cancer is responding to treatment with pembrolizumab. A second stage of the study will take place once stage 1 is completed. In stage 2 blood tests will be used to help determine if patients whose cancer does not seem to be getting better on treatment with pembrolizumab, would do better on a different treatment.

View this trial on ClinicalTrials.gov