NCT02998528|CompletedPhase 3ResultsDMCFDA Drug

A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)

CheckMate 816

Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC

Bristol-Myers Squibb ClinicalTrials.gov

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2 other identifiers

CA209-8162016-003536-21

Study Type

interventional

Target

505

Locations

15 countries

Sites

138

Timeline

RegisteredDec 2016

StartedMar 2017

CompletionDec 2024

Brief Summary

The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus ipilimumab's safety and effectiveness in treating resectable NSCLC. This study has multiple primary endpoints.

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

505

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Mar 2017

Longer than P75 for phase_3

Geographic Reach

15 countries

138 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

7.8 years study duration

First Submitted

Initial submission to the registry

December 16, 2016

Completed

4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2016

Completed

2 months until next milestone

Study Start

First participant enrolled

March 4, 2017

Completed

4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2021

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

September 28, 2022

Completed

2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2024

Completed

Last Updated

January 6, 2026

Status Verified

January 1, 2026

Enrollment Period

4.5 years

First QC Date

December 16, 2016

Results QC Date

August 31, 2022

Last Update Submit

January 2, 2026

Conditions

Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

Event-Free Survival (EFS)
Event-free survival (EFS) is defined as the length of time from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on blinded independent central review (BICR) assessment per response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months)
Pathologic Complete Response (pCR) Rate
Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR).
From randomization up to a median of 30 months after randomization.

Secondary Outcomes (3)

Major Pathologic Response (MPR) Rate
From randomization up to a median of 30 months after randomization.
Overall Survival (OS)
From randomization to the date of death (Up to approximately 93 months)
Time to Death or Distant Metastases (TTDM)
From randomization to the first date of distant metastasis or the date of death in the absence of distant metastasis (Up to approximately 84 months)