Study on Tailoring Immunotherapy Based on ctDNA Response in Non-Small Cell Lung Cancer (NSCLC)

Sponsor: Canadian Cancer Trials Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04093167

Provider View

This clinical trial is exploring whether adjusting immunotherapy treatment based on ctDNA levels can improve outcomes for patients with non-small cell lung cancer (NSCLC).

Patient Parameters

Program Overview

The BR36 study is an international trial that looks at how changing immunotherapy treatment based on ctDNA (circulating tumor DNA) response can benefit patients with advanced non-small cell lung cancer (NSCLC) who have not received prior immunotherapy or chemotherapy. The trial will test if adding chemotherapy to the drug pembrolizumab for patients with persistent ctDNA after 6 weeks of treatment can lead to better survival outcomes compared to continuing pembrolizumab alone until the cancer progresses.

Description

The BR36 trial is a large, international study that aims to see if adjusting treatment based on ctDNA levels can help patients with advanced non-small cell lung cancer (NSCLC). This study is for patients who have not had chemotherapy or immunotherapy before and have a high level of a protein called PD-L1 in their cancer cells. The trial will compare two groups: one group will continue with the immunotherapy drug pembrolizumab, and the other group will add chemotherapy to pembrolizumab if ctDNA is still present after 6 weeks of treatment. The goal is to see if this approach can improve how long patients live without their cancer getting worse and their overall survival.

Participants must have a confirmed diagnosis of metastatic NSCLC and meet specific health criteria. They will need to provide a blood sample for ctDNA testing and agree to follow the study's treatment plan and visits. The study will monitor participants' health and response to treatment closely.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC) that cannot be removed by surgery or treated with radiation.
  • Do not have a specific type of lung cancer called Large Cell Neuroendocrine Carcinoma (LCNEC).
  • Have cancer that does not have certain genetic mutations (EGFR and ALK negative).
  • Have a high level of PD-L1 protein (≥ 50%) in cancer cells.
  • Have started treatment with pembrolizumab and received a specific number of doses.
  • Have not had chemotherapy or immunotherapy for metastatic cancer in the last 6 months.
  • Be in good overall health with a performance status score of 0 to 2.
  • Have detectable ctDNA in a blood test.
  • Have adequate blood cell counts and organ function.
  • Be 18 years or older.
  • Agree to provide a tumor tissue sample if available.
  • Agree to use effective birth control if of childbearing potential.
  • Be willing to follow the study's treatment plan and attend follow-up visits.

Exclusion Criteria

  • Have another type of cancer that could interfere with the study.
  • Have active or untreated brain metastases requiring high doses of steroids.
  • Have conditions that make pembrolizumab treatment unsuitable, such as active infections or autoimmune diseases.
  • Have a history of severe immune-related side effects from similar treatments.
  • Have significant mental health issues that affect consent or compliance.
  • Be receiving other cancer treatments or investigational drugs.
  • Be pregnant or breastfeeding.

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