Immunotherapy + Chemotherapy for Lung Cancer (CheckMate 9LA Trial)

Phase 3

Waitlist Available

Research Sponsored by Bristol-Myers Squibb

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants with histologically confirmed Stage IV or recurrent NSCLC squamous or non-squamous histology, with no prior systemic anticancer therapy

Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1

Must not have

Participants with known epidermal growth factor receptor (EGFR) mutations which are sensitive to available targeted inhibitor therapy (including, but not limited to, deletions in exon 19 and exon 21 [L858R] substitution mutations) are excluded

Participants with known anaplastic lymphoma kinase (ALK) translocations which are sensitive to available targeted inhibitor therapy are excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of randomization to date of death (assessed up to october 2019, approximately 23 months)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare the effectiveness of two different treatment plans for stage IV NSCLC.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Nivolumab and Ipilimumab can cause immune-related side effects such as inflammation in various organs, skin rash, hormone gland problems, fatigue, and infusion reactions. Chemotherapy may lead to nausea, hair loss, blood cell count changes increasing infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I can carry out all my self-care but might not be able to do heavy physical work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I do not have ALK translocations sensitive to current treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to october 2019, approximately 23 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to october 2019, approximately 23 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to october 2019, approximately 23 months) for reporting.