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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 7 years

Awards & highlights

CheckMate73L Trial 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.Check my eligibility

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.See study design

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.

CheckMate73L Trial 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.

CheckMate73L Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 7 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free survival (PFS) by RECIST 1.1 per Blinded Independent Central Review (BICR) for Arm A vs Arm C

Secondary outcome measures

DoR by RECIST 1.1 per Investigator assessment

Duration of Response (DoR) by RECIST 1.1 per BICR

Incidence of Adverse Events (AEs)

+14 more

CheckMate73L 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

nivolumab

2016

Completed Phase 3

~4960

durvalumab

2017

Completed Phase 2

~400

ipilimumab

2016

Completed Phase 3

~5520

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,638 Previous Clinical Trials

4,127,626 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there a lot of different places where this trial is taking place?

"Currently, this trial is looking for participants at the Local Institution - 0188 in Cincinnati, Ohio, Local Institution - 0130 in Dallas, Texas, Local Institution - 0125 in Atlanta, Georgia as well as 62 other medical centres."

Answered by AI

Does nivolumab have a history of being studied in medical trials?

"Nivolumab was first trialled in 2009 at Texas Children's Hospital. Since then, there have been 455 completed studies with 1127 live studies. A large portion of these nivolumab trials are being conducted in Cincinnati, Ohio."

Answered by AI

What are the primary diseases that nivolumab has been shown to mitigate?

"Nivolumab is an effective treatment for unresectable melanoma, squamous cell carcinoma, and cases where there is a high risk of cancer recurrence."

Answered by AI

What is the nivolumab FDA approval process?

"There is some evidence from previous trials to support nivolumab's efficacy, and it has received multiple rounds of safety testing. Therefore, our team rates its safety as a 3."

Answered by AI

Recent research and studies

Clinical Lung CancerJournal

Checkmate 73L: A Phase 3 Study Comparing Nivolumab Plus Concurrent Chemoradiotherapy Followed by Nivolumab with or Without Ipilimumab Versus Concurrent Chemoradiotherapy Followed by Durvalumab for Previously Untreated, Locally Advanced Stage III Non-small-cell Lung Cancer

De Ruysscher, Dirk, Suresh Ramalingam, James Urbanic, David E Gerber, Daniel S.W. Tan, Junliang Cai, Ang Li, and Solange Peters. 2022. “Checkmate 73L: A Phase 3 Study Comparing Nivolumab Plus Concurrent Chemoradiotherapy Followed by Nivolumab with or Without Ipilimumab Versus Concurrent Chemoradiotherapy Followed by Durvalumab for Previously Untreated, Locally Advanced Stage III Non-small-cell Lung Cancer”. Clinical Lung Cancer. Elsevier BV. doi:10.1016/j.cllc.2021.07.005.

clinicaltrials.govStudy

A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery

2019. "A Study of Nivolumab and Ipilimumab in Untreated Participants With Stage 3 Non-small Cell Lung Cancer (NSCLC) That is Unable or Not Planned to be Removed by Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04026412.

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