Immunotherapy + Chemotherapy for Lung Cancer

(CheckMate 9LA Trial)

Recruiting at 233 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Bristol-Myers Squibb

Must not be taking: EGFR inhibitors, ALK inhibitors

Disqualifiers: EGFR mutations, ALK translocations, untreated CNS metastases

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 23 months

719 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine whether Nivolumab, Ipilimumab combined with chemotherapy is more effective than chemotherapy by itself when treating stage IV NSCLC as the first treatment given for the disease

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for adults with Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC) who haven't had cancer treatment before. They should have measurable disease, be in good physical condition (ECOG ≤1), and not have certain gene mutations like EGFR or ALK that respond to other drugs. People with untreated brain metastases are excluded.

Inclusion Criteria

Your PD-L1 levels must be tested by a central lab before you can join the study.

Your disease can be measured using CT or MRI scans according to specific guidelines.

My lung cancer is at stage IV or recurrent and I haven't had cancer drugs before.

Exclusion Criteria

My brain metastases are treated, and I've been stable for 2 weeks.

My cancer does not have EGFR mutations treatable with targeted therapy.

I do not have ALK translocations sensitive to current treatments.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Nivolumab and Ipilimumab combined with chemotherapy or chemotherapy alone

23 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

23 months

Every 3 months

Treatment Details

Interventions

• Carboplatin
• Cisplatin
• Ipilimumab
• Nivolumab
• Paclitaxel
• Pemetrexed

Trial Overview The study is testing if a combination of the immune therapies Nivolumab and Ipilimumab with chemotherapy works better than chemotherapy alone as the first line of attack against advanced NSCLC. Participants will receive either the drug combo or just chemo to compare effectiveness.

Participant Groups

Group I: Module A Experimental Treatment 6 Interventions

Chemotherapy/Biologics combined

Group II: Module B Active Control 4 Interventions

Chemotherapy Combination

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

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

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania