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Anti-tumor antibiotic

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

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

CheckMate 9LA 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.Check my eligibility

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.See study design

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.

CheckMate 9LA 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 stage IV or recurrent and I haven't had cancer drugs before.

Select...

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

CheckMate 9LA Trial 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.

Treatment Details

Study Objectives

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

Primary outcome measures

Overall Survival (OS)

Secondary outcome measures

Duration of Response (DoR)

OS by PD-L1 Tumor Cell Expression

Objective Response Rate (ORR) by BICR

+4 more

CheckMate 9LA Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Module AExperimental Treatment6 Interventions

Chemotherapy/Biologics combined

Group II: Module BActive Control4 Interventions

Chemotherapy Combination

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ipilimumab

2014

Completed Phase 3

~2620

Carboplatin

2014

Completed Phase 3

~6670

Paclitaxel

2011

Completed Phase 4

~5380

Cisplatin

2013

Completed Phase 3

~1940

Nivolumab

2014

Completed Phase 3

~4750

Pemetrexed

2014

Completed Phase 3

~5250

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor

2,638 Previous Clinical Trials

4,127,795 Total Patients Enrolled

Media Library

Carboplatin (Anti-tumor antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT03215706 — Phase 3

Non-Small Cell Lung Cancer Research Study Groups: Module A, Module B

Non-Small Cell Lung Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT03215706 — Phase 3

Carboplatin (Anti-tumor antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03215706 — Phase 3

Frequently Asked Questions

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

How many people are included in this test group?

"Enrolment for this study is currently closed. The trial was originally posted on 8/24/2017, with the latest update being 11/11/2022. If you are looking for other studies, there are 2095 clinical trials actively admitting patients with lung cancer and 2335 studies for Ipilimumab searching for patients."

Answered by AI

Has Ipilimumab received regulatory approval from the FDA?

"Our team at Power estimates that Ipilimumab is safe enough to warrant a score of 3 on our scale. This is because there is some data supporting efficacy and multiple rounds of data supporting safety in Phase 3 trials."

Answered by AI

What does the current research say about Ipilimumab's effectiveness?

"Ipilimumab's first study was completed in 1997 at City of Hope Comprehensive Cancer Center. Since that time, there have been a total of 2722 studies involving ipilimumab with 2335 active trials currently being conducted; many of which are based out of Johnson City, New york."

Answered by AI

Are patients currently being accepted for this clinical trial?

"Although this trial is not presently looking for new candidates, 4430 other studies are. This specific study was posted on 8/24/2017 and last edited on 11/11/2022 according to the clinicaltrials.gov website."

Answered by AI

For what purpose is Ipilimumab most often given to patients?

"Ipilimumab is indicated for the treatment of malignant neoplasms. It has also shown to be effective in treating unresectable melanoma, squamous cell carcinoma, and locally advanced nonsquamous non-small cell lung cancer."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

First-line Nivolumab Plus Ipilimumab Combined with Two Cycles of Chemotherapy in Patients with Non-small-cell Lung Cancer (checkmate 9LA): An International, Randomised, Open-label, Phase 3 Trial

Paz-Ares, Luis, Tudor-Eliade Ciuleanu, Manuel Cobo, Michael Schenker, Bogdan Zurawski, Juliana Menezes, Eduardo Richardet, et al.. 2021. “First-line Nivolumab Plus Ipilimumab Combined with Two Cycles of Chemotherapy in Patients with Non-small-cell Lung Cancer (checkmate 9LA): An International, Randomised, Open-label, Phase 3 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(20)30641-0.

clinicaltrials.govStudy

A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC

2017. "A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03215706.