NCT04093167

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: Canadian Cancer Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is being done in two stages. Participants are being invited to participate in stage 2. The purpose of stage 1 of the study was to find out how soon ctDNA disappears from blood in patients with lung cancer treated with pembrolizumab and whether ctDNA disappearance or continued detection related to how well people did. In stage 2 the study will use the blood tests to figure out if patients on treatment with pembrolizumab with ctDNA that is still detected in the blood after 6 weeks of pembrolizumab could do better by adding standard chemotherapy treatment before the cancer is worse compared to continuing on standard pembrolizumab without added chemotherapy.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Per current Product Monograph/U.S. Drug Label and/or local guidelines.

Timeline

• Start date: 2020-05-26
• Primary completion: 2026-12-31
• Completion: 2027-07-30
• First posted: 2019-09-17
• Last updated: 2026-03-11

Locations

10 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study