Immunotherapy for Lung Cancer
(NA_00092076 Trial)

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen byPatrick Forde, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The proposed study will evaluate the safety and feasibility of preoperative administration nivolumab +/- ipilimumab in patients with high-risk resectable NSCLC, and will facilitate a comprehensive exploratory characterization of the tumor immune milieu and circulating immune cells and soluble factors in these patients. Data obtained in this study will provide valuable information for planning further prospective clinical trials of anti-PD-1 and other immunotherapies in NSCLC, both in the peri-operative and advanced disease setting.

Eligibility Criteria

This trial is for adults with high-risk resectable non-small cell lung cancer (NSCLC), who have good organ function and performance status. They must not be incarcerated, pregnant, or have other serious health issues like active infections or autoimmune diseases. Participants need to agree to use contraception and provide tissue samples for research.

Inclusion Criteria

My lung cancer diagnosis was confirmed with a core biopsy.

Diagnostic core biopsy specimens must be reviewed by a faculty pathologist at SKCCC or MSKCC

I am fully active or can carry out light work.

+9 more

Exclusion Criteria

History of allergy to study drug components

I have tested positive for HIV/AIDS.

I have received cancer treatment before surgery.

+11 more

Participant Groups

The study tests the safety of giving Nivolumab alone or with Ipilimumab before surgery in NSCLC patients. It also looks at how these drugs affect immune cells in tumors and blood. The goal is to inform future trials on immunotherapies for both early-stage and advanced lung cancer.

3Treatment groups

Experimental Treatment

Group I: Arm C- Nivolumab, Carboplatin, & PaclitaxelExperimental Treatment3 Interventions

Nivolumab 360 mg IV, Carboplatin AUC 5 or 6 IV, and Paclitaxel 175 or 200 mg/m2 IV every 21 days for 3 cycles prior to planned surgery on Day 0.

Group II: Arm B- NivolumabExperimental Treatment1 Intervention

Nivolumab administration: Three doses of nivolumab will be administered to enrolled patients on Day -42, Day -28, and Day-14 (+/- two days) prior to planned surgery on Day 0 or up to +10 days.

Group III: Arm A- Nivolumab and IpilimumabExperimental Treatment2 Interventions

One dose of Nivolumab 3mg/kg IV \& Ipilimumab 1mg/kg will be administered to enrolled patients on Day-42, then 2 doses of Nivolumab 3mg/kg will be administered to enrolled patients on Day-28 and Day-14