NCT02477826|CompletedPhase 3ResultsDMCFDA Drug

An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)

CheckMate 227

An Open-Label, Randomized Phase 3 Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Subjects With Chemotherapy-Naïve Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)

Bristol-Myers Squibb ClinicalTrials.gov

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2 other identifiers

CA209-2272014-003630-23

Study Type

interventional

Target

2,747

Locations

32 countries

Sites

280

Timeline

RegisteredJun 2015

StartedAug 2015

CompletionOct 2024

Brief Summary

The purpose of this study is to show that Nivolumab, or Nivolumab plus Ipilimumab, or Nivolumab plus Platinum-Doublet Chemotherapy improves progression free survival and/or overall survival compared with chemotherapy in patients with advanced lung cancer.

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

2,747

participants targeted

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

Timeline

Completed

Started Aug 2015

Longer than P75 for phase_3 nonsmall-cell-lung-cancer

Geographic Reach

32 countries

280 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

9.2 years study duration

First Submitted

Initial submission to the registry

June 18, 2015

Completed

5 days until next milestone

First Posted

Study publicly available on registry

June 23, 2015

Completed

1 month until next milestone

Study Start

First participant enrolled

August 5, 2015

Completed

9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2024

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2024

Completed

1 year until next milestone

Results Posted

Study results publicly available

October 30, 2025

Completed

Last Updated

October 30, 2025

Status Verified

October 1, 2025

Enrollment Period

9.2 years

First QC Date

June 18, 2015

Results QC Date

October 21, 2025

Last Update Submit

October 21, 2025

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

Progression-Free Survival Per BICR
Progression-Free Survival then (PFS) is defined as the time between the date of randomization and the date of first documented disease progression, based on BICR assessments (per RECIST v1.1), or death due to any cause, whichever occurs first based on Kaplan-Meier estimates. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum during the study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks)
Overall Survival
OS for all randomized participants is the time between randomization date and the date of death from any cause.
From randomization untill death or last follow up whichever occurs first (up to approximately 481 weeks)

Secondary Outcomes (2)

Objective Response Rate (ORR) Per BICR
From randomization untill disease progression or death, whichever occurs first (up to approximately 481 weeks)
Percentage of Participants With Symptom Deterioration at Week 12 Assessed Via Lung Cancer Symptom Scale
Week 12

Study Arms (4)

Arm A: Nivolumab

EXPERIMENTAL

Nivolumab intravenously (IV) as specified

Drug: Nivolumab

Arm B: Nivolumab + Ipilimumab

EXPERIMENTAL

Nivolumab + Ipilimumab IV as specified

Drug: NivolumabDrug: Ipilimumab

Arm C: Nivolumab + Platinum doublet chemotherapy

EXPERIMENTAL

Nivolumab + Platinum doublet chemotherapy (IV) dose as specified

Drug: NivolumabDrug: CarboplatinDrug: CisplatinDrug: GemcitabineDrug: PemetrexedDrug: Paclitaxel

Arm D: Platinum doublet chemotherapy

EXPERIMENTAL

Chemotherapy administered on specified days of IV chemotherapy

Drug: CarboplatinDrug: CisplatinDrug: GemcitabineDrug: PemetrexedDrug: Paclitaxel

Interventions

NivolumabDRUG

Also known as: Opdivo

Arm A: NivolumabArm B: Nivolumab + IpilimumabArm C: Nivolumab + Platinum doublet chemotherapy

IpilimumabDRUG

Also known as: Yervoy

Arm B: Nivolumab + Ipilimumab

CarboplatinDRUG