Study of Nivolumab-Ipilimumab and cfDNA in Lung Cancer

Official Title

Beyond Chemotherapy: Nivolumab-Ipilimumab With cfDNA-guided Treatment Intensification as a Chemotherapy-sparing Strategy in Metastatic Non-small Cell Lung Cancer

Summary:

The purpose of this research study is to look at how effective two drugs, nivolumab and ipilimumab, are for people with non-small lung cancer that has metastasized (has spread to other parts of the body) and to see what effects these drugs have on these tumours.

Trial Description

Primary Outcome:

• Percentage of participants whose disease does not worsen (progression-free survival rate) at 6 months

Secondary Outcome:

• Average percentage of tumour cfDNA detected in the blood (tumour cfDNA clearance rate) at 3 weeks
• Average percentage of tumour cfDNA detected in the blood (tumour cfDNA clearance rate) at 12 weeks
• Number participants with adverse events
• Average time from the date of study enrolment until death (overall survival)

The study will use a special blood test to evaluate the response of the cancer to treatment. This blood test will analyze tumour DNA present in the blood (deoxyribonucleic acid, molecules that contain instructions for the development and function of cells). Patients that do not have evidence of a good response using this blood test will also undergo a short course of chemotherapy in addition to nivolumab and ipilimumab.

View this trial on ClinicalTrials.gov