RecruitingPhase 2NCT04991025

Adding Certolizumab to Chemotherapy + Nivolumab in People Who Have Lung Cancer That Can Be Treated With Surgery

Phase 2 Trial of Neoadjuvant Nivolumab + Platinum-based Chemotherapy + Certolizumab in Patients With Resectable Stages II-III Lung Cancers

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

60 participants

Start Date

Oct 19, 2022

Study Type

INTERVENTIONAL

Conditions

Lung Cancer Lung Cancer Stage II Lung Cancer Stage III

Summary

The purpose of the study is to explore adding the study drug certolizumab to standard chemotherapy as it may reduce the inflammation caused by the cancer and make the chemotherapy more effective in shrinking the cancer. This study will examine whether adding certolizumab to the usual treatment approach is better than, the same as, or worse than the usual approach alone.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding certolizumab (a drug that calms inflammation) to the standard combination of chemotherapy and the immunotherapy drug nivolumab before lung cancer surgery can improve outcomes in patients with operable non-small cell lung cancer. **You may be eligible if...** - You have stage II or III non-small cell lung cancer that can be surgically removed - Your disease is confirmed at the study institution - You are 18 or older with good performance status (Karnofsky ≥70) - You have adequate blood, liver, and kidney function - You tested negative for tuberculosis, HIV, and hepatitis B - You have not had prior immunotherapy or TNF-blocking drugs **You may NOT be eligible if...** - Your cancer has a specific gene mutation for which there is an FDA-approved targeted therapy - You are allergic to platinum chemotherapy - You have an active autoimmune disease or immune deficiency - You have had significant heart problems (heart attack, unstable angina) in the past year - You have had prior allogeneic stem cell or solid organ transplant - You are pregnant or breastfeeding - You received another investigational treatment in the last 28 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCisplatin

Participants with lung adenocarcinoma will receive standard of care neoadjuvant cisplatin 75mg/m2 + pemetrexed 500mg/m2 intravenously on day 1 of a 21 day cycle. Participants with squamous cell lung carcinoma will receive cisplatin 75mg/m2 IV on day 8 of a 21 day cycle + gemcitabine 1000mg/m2 IV days 1 and 8 of a 21 day cycle.

DRUGPemetrexed

Participants with lung adenocarcinoma will receive standard of care neoadjuvant cisplatin 75mg/m2 + pemetrexed 500mg/m2 intravenously on day 1 of a 21 day cycle

DRUGGemcitabine

Participants with squamous cell lung carcinoma will receive cisplatin 75mg/m2 IV on day 8 of a 21 day cycle + gemcitabine 1000mg/m2 IV days 1 and 8 of a 21 day cycle.

DRUGCarboplatin

Participants not eligible for cisplatin (per treating physician discretion) may receive carboplatin at AUC = 5 instead of cisplatin.

DRUGCertolizumab

Certolizumab 400mg subq will be administered in clinic within 1 hour before the start of chemotherapy on day 1 of a 21 day cycle.

DRUGNivolumab

Participants with lung adenocarcinoma will receive standard of care neoadjuvant cisplatin 75mg/m2 + pemetrexed 500mg/m2 + nivolumab 360mg intravenously on day 1 of a 21 day cycle Participants with squamous cell lung carcinoma will receive cisplatin 75mg/m2 IV on day 8 of a 21 day cycle + gemcitabine 1000mg/m2 IV days 1 and 8 of 21 day cycle + nivolumab 360mg IV on day 1 of 21 day cycle.