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

PHASE2RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

October 19, 2022

Primary Completion Date

October 31, 2026

Study Completion Date

October 31, 2026

Conditions
Lung CancerLung Cancer Stage IILung Cancer Stage III
Interventions
DRUG

Cisplatin

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.

DRUG

Pemetrexed

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

DRUG

Gemcitabine

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.

DRUG

Carboplatin

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

DRUG

Certolizumab

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

DRUG

Nivolumab

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.

Trial Locations (7)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York

10604

RECRUITING

Memorial Sloan Kettering Westchester (All Protocol Activities), Harrison

11553

RECRUITING

Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale

11725

RECRUITING

Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity), Commack

07920

RECRUITING

Memorial Sloan Kettering at Basking Ridge Limited Protocol Activities, Basking Ridge

07748

RECRUITING

Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown

07645

RECRUITING

Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale

All Listed Sponsors
lead

Memorial Sloan Kettering Cancer Center

OTHER