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Checkpoint Inhibitor

Nivolumab + Ipilimumab for Lung Cancer (CheckMate73L 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
Locally advanced stage IIIA, IIIB, or IIIC (T1-2 N2-3 M0, T3 N1-3 M0, or T4 N0-3 M0) pathologically-confirmed NSCLC, according to 8th TNM classification. Participants who are not planned for potential curative surgical resection are eligible.
Newly diagnosed and treatment-naïve, with no prior local or systemic anticancer therapy given as primary therapy for locally advanced disease
Must not have
History of organ or tissue transplant that requires systemic use of immune suppressive agents
Prior thoracic radiotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 years
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial will compare two different treatments for locally advanced non-small cell lung cancer.

Who is the study for?
This trial is for adults with untreated stage 3 non-small cell lung cancer that can't be removed by surgery. Participants should have a good performance status (ECOG ≤1), meaning they're fairly active and able to care for themselves. They must not have had any previous treatments for their lung cancer, no history of organ transplants requiring immune suppression, no prior chest radiotherapy, and no active infections needing treatment within the last two weeks.
What is being tested?
The study aims to compare two approaches: one group will receive nivolumab with chemoradiotherapy followed by nivolumab plus ipilimumab; another group gets chemoradiotherapy followed by durvalumab. The goal is to see which combination is more effective in treating locally advanced non-small cell lung cancer.
What are the potential side effects?
Nivolumab and ipilimumab may cause immune-related side effects like inflammation in various organs, skin rash, hormone gland problems (like thyroid or adrenal issues), digestive tract symptoms (diarrhea or colitis), liver inflammation, and potential infusion reactions. Durvalumab might also lead to similar immune-mediated side effects.

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 an advanced stage but hasn't spread beyond my lungs.
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I have not received any treatment for my advanced cancer.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had an organ or tissue transplant and take medication to suppress my immune system.
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I have had radiation therapy to the chest area before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Proportion of participants without symptom deterioration based on NSCLC-SAQ

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Arm C: CCRT + durvalumabExperimental Treatment1 Intervention
Concurrent chemoradiotherapy (CCRT)
Group II: Arm B: nivolumab + CCRTExperimental Treatment1 Intervention
Concurrent chemoradiotherapy (CCRT)
Group III: Arm A: nivolumab + CCRT + ipilimumabExperimental Treatment2 Interventions
Concurrent chemoradiotherapy (CCRT)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ipilimumab
2016
Completed Phase 3
~6380
nivolumab
2016
Completed Phase 3
~6290
durvalumab
2017
Completed Phase 3
~1210

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,696 Previous Clinical Trials
4,098,146 Total Patients Enrolled

Media Library

Ipilimumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04026412 — Phase 3
Non-Small Cell Lung Cancer Clinical Trial 2023: Ipilimumab Highlights & Side Effects. Trial Name: NCT04026412 — Phase 3
Ipilimumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04026412 — Phase 3
Non-Small Cell Lung Cancer Research Study Groups: Arm C: CCRT + durvalumab, Arm B: nivolumab + CCRT, Arm A: nivolumab + CCRT + ipilimumab
~148 spots leftby Jan 2026
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