NCT03215706|CompletedPhase 3ResultsDMCFDA Drug

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

CheckMate 9LA

A Phase 3, Randomized Study of Nivolumab Plus Ipilimumab in Combination With Chemotherapy vs Chemotherapy Alone as First Line Therapy in Stage IV Non-Small Cell Lung Cancer

Bristol-Myers Squibb ClinicalTrials.gov

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2 other identifiers

CA209-9LA2017-001195-35

Study Type

interventional

Target

719

Locations

19 countries

Sites

116

Timeline

RegisteredJul 2017

StartedAug 2017

CompletionOct 2024

Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

719

participants targeted

Target at P75+ for phase_3 nonsmall-cell-lung-cancer

Timeline

Completed

Started Aug 2017

Typical duration for phase_3 nonsmall-cell-lung-cancer

Geographic Reach

19 countries

116 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.2 years study duration

First Submitted

Initial submission to the registry

July 11, 2017

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 12, 2017

Completed

1 month until next milestone

Study Start

First participant enrolled

August 24, 2017

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2019

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

September 16, 2020

Completed

4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2024

Completed

Last Updated

December 17, 2025

Status Verified

December 1, 2025

Enrollment Period

2 years

First QC Date

July 11, 2017

Results QC Date

August 15, 2020

Last Update Submit

December 2, 2025

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

Overall Survival (OS)
OS was defined as the time from randomization to the date of death from any cause. OS was censored on the last date a subject was known to be alive. Survival follow-up was to be conducted every 3 months after participants's off-treatment date.
From date of randomization to date of death (assessed up to October 2019, approximately 23 months)

Secondary Outcomes (10)

Progression Free Survival (PFS) by BICR
From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)
Objective Response Rate (ORR) by BICR
From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)
Duration of Response (DoR)
From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)
Time to Response (TTR)
From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)
Objective Response Rate (ORR) by BICR by PD-LI Tumor Cell Expression
From date of randomization until date of documented tumor progression or death due to any cause, whichever occurs first (assessed up to October 2024, approximately 72 months)
+5 more secondary outcomes

Study Arms (2)

Module A

EXPERIMENTAL

Chemotherapy/Biologics combined

Biological: IpilimumabBiological: NivolumabDrug: CarboplatinDrug: PaclitaxelDrug: PemetrexedDrug: Cisplatin

Module B

ACTIVE COMPARATOR

Chemotherapy Combination

Drug: CarboplatinDrug: PaclitaxelDrug: PemetrexedDrug: Cisplatin