An Open Label, Randomized Study of Neoadjuvant Nivolumab and Chemotherapy, With or Without Sub-ablative Stereotactic Body Radiation Therapy, for Resectable Stage IIA to IIIB Non-small Cell Lung Cancer

PHASE2RecruitingINTERVENTIONAL
Enrollment

52

Participants

Timeline

Start Date

January 25, 2023

Primary Completion Date

July 31, 2025

Study Completion Date

July 31, 2025

Conditions
Resectable Stage IIA to IIIB Non-small Cell Lung Cancer
Interventions
DRUG

Nivolumab

Patients randomized to the Nivolumab + Platinum Doublet Chemotherapy only arm will receive three cycles of nivolumab at a dose of 360 mg every three weeks along with a platinum-based chemotherapy doublet (cisplatin or carboplatin plus pemetrexed for adenocarcinoma, cisplatin or carboplatin plus docetaxel, paclitaxel, or gemcitabine for squamous NSCLC) with sub-ablative stereotactic radiation therapy (8 Gy x 3) directed at the primary lung tumor

RADIATION

(8gy x 3)

sub-ablative stereotactic radiation therapy (8 Gy x 3) directed at the primary lung tumor

DRUG

Platinum Doublet

Standard of care doublet platinum therapy

Trial Locations (1)

10461

RECRUITING

Montefiore Medical Center-Albert Einstein College of Medicine, The Bronx

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Montefiore Medical Center

OTHER