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Compensation: Varies

Number of Visits: Unknown

Duration: Up to 30 months

505 Participants Needed

Immunotherapy + Chemotherapy for Lung Cancer
(CheckMate 816 Trial)

Recruiting at 253 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bristol-Myers Squibb

Must not be taking: Checkpoint inhibitors

Disqualifiers: Metastatic disease, Autoimmune disease, others

Stay on Your Current MedsYou can continue your current medications while participating

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval

Prior Safety DataThis treatment has passed at least one previous human trial

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.

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

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.

See 1 more

Exclusion Criteria

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

You have a known autoimmune disease that is currently active or suspected.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either nivolumab plus ipilimumab, nivolumab plus platinum doublet chemotherapy, or platinum doublet chemotherapy alone

Up to 30 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 30 months

Treatment Details

Interventions

Carboplatin
Ipilimumab
Nivolumab
Paclitaxel
Pemetrexed

Trial Overview 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.

Participant Groups

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:

Ovarian cancer
Testicular cancer
Lung cancer
Head and neck cancer
Brain cancer

Approved in European Union as Carboplatin for:

Ovarian cancer
Small cell lung cancer

Approved in Canada as Carboplatin for:

Ovarian cancer
Small cell lung cancer
Testicular cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

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