NCT04966676

Study of Nivolumab-Ipilimumab and cfDNA in Lung Cancer

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 tumors.

Detailed description

The study will use a special blood test to evaluate the response of the cancer to treatment. This blood test will analyze tumor 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.

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	cfDNA blood test	Blood sample will be taken for cfDNA testing
DRUG	Nivolumab	Antineoplastic agent
DRUG	Ipilimumab	Antineoplastic agent
COMBINATION_PRODUCT	Platinum-based Chemotherapy	May include carboplatin with gemcitabine, or paclitaxel or pemetrexed

Timeline

• Start date: 2022-01-24
• Primary completion: 2025-02-19
• Completion: 2025-02-19
• First posted: 2021-07-19
• Last updated: 2026-01-08

Locations

1 site across 1 country: Canada