Immunotherapy + Chemotherapy for Lung Cancer (CheckMate 816 Trial)

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Bristol-Myers Squibb

Stay on your current meds

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC. This study has multiple primary endpoints.

Eligibility Criteria

This trial is for people with early-stage IB-IIIA operable non-small cell lung cancer (NSCLC) who have good lung function and can handle surgery. They should be relatively healthy, which means having an ECOG Performance Status of 0-1. Those with advanced inoperable or metastatic disease, autoimmune diseases, or previous treatments targeting T cell pathways cannot join.

Inclusion Criteria

My lungs are strong enough for surgery.

I have a sample of my lung tumor available.

I am fully active or can carry out light work.

My lung cancer is in early stage IB-IIIA and can be operated on.

Exclusion Criteria

I have been treated with drugs that boost the immune system.

My cancer cannot be removed by surgery and may have spread.

Treatment Details

The study tests the safety and effectiveness of adding Nivolumab to chemotherapy before surgery compared to just chemotherapy alone. It also examines how safe and effective it is to combine Nivolumab with Ipilimumab versus the standard treatment for resectable NSCLC.

3Treatment groups

Experimental Treatment

Active Control

Group I: Nivolumab plus platinum doublet chemotherapyExperimental Treatment6 Interventions

Specified dose on specified days

Group II: Nivolumab plus IpilimumabExperimental Treatment2 Interventions

Specified dose on specified days

Group III: Platinum doublet chemotherapyActive Control7 Interventions

Specified dose on specified days

Carboplatin is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Paraplatin for: