NCT02864251|CompletedPhase 3ResultsDMCFDA Drug

A Study of Nivolumab + Chemotherapy or Nivolumab + Ipilimumab Versus Chemotherapy in Non-Small Cell Lung Cancer (NSCLC) Participants With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor (TKI) Therapy

CheckMate722

Open-Label, Randomized Trial of Nivolumab (BMS-936558) Plus Pemetrexed/Platinum or Nivolumab Plus Ipilimumab (BMS-734016) vs Pemetrexed Plus Platinum in Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) Subjects With Epidermal Growth Factor Receptor (EGFR) Mutation Who Failed 1L or 2L EGFR Tyrosine Kinase Inhibitor Therapy

Bristol-Myers Squibb ClinicalTrials.gov

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2 other identifiers

CA209-7222017-002672-38

Study Type

interventional

Target

367

Locations

10 countries

Sites

109

Timeline

RegisteredAug 2016

StartedMar 2017

CompletionOct 2022

Brief Summary

The main purpose of this study is to determine whether nivolumab + chemotherapy is effective as compared to chemotherapy in the treatment of patients with EGFR mutation, NSCLC who failed first line (1L) or second-line (2L) EGFR TKI therapy.

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

367

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Mar 2017

Longer than P75 for phase_3

Geographic Reach

10 countries

109 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

5.6 years study duration

First Submitted

Initial submission to the registry

August 9, 2016

Completed

2 days until next milestone

First Posted

Study publicly available on registry

August 11, 2016

Completed

7 months until next milestone

Study Start

First participant enrolled

March 17, 2017

Completed

4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2022

Completed

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2022

Completed

4 months until next milestone

Results Posted

Study results publicly available

February 6, 2023

Completed

Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

4.8 years

First QC Date

August 9, 2016

Results QC Date

January 10, 2023

Last Update Submit

September 6, 2023

Conditions

Non-Small-Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

Progression Free Survival (PFS) by Blinded Independent Centralized Review (BICR)
PFS is defined as the time between the date of randomization and the date of first documented tumor progression, as determined by BICR (per RECIST v1.1 criteria), or death due to any cause, whichever occurs first. Participants who died without reported progression will be considered to have progressed on the date of their death. Subsequent therapy was accounted for by censoring at the last evaluable tumor assessment on or prior to the date of subsequent therapy. Progression is the appearance of one or more new lesions. RECIST - "response evaluation criteria in solid tumors" is a standard system to measure tumor response to treatment. Based on Kaplan-Meier estimates
From randomization to the date of first documented tumor progression or death (approximately 58 months)

Secondary Outcomes (5)

Overall Survival (OS)
From randomization to the date of death due to any cause (up to approximately 67 months)
Objective Response Rate (ORR) by Blinded Independent Centralized Review (BICR)
From randomization to the date of objectively documented progression, date of death, or the date of subsequent therapy (up to approximately 67 months)
Duration of Response (DOR) by Blinded Independent Centralized Review (BICR)
From randomization to the date of first documented disease progression or death due to any cause (approximately 67 months)
9 Month Progression Free Survival Rates (PFSR) by Blinded Independent Centralized Review (BICR)
9 months after first treatment dose
12 Month Progression Free Survival Rates (PFSR) by Blinded Independent Centralized Review (BICR)
12 Months after first treatment dose

Study Arms (3)

Nivolumab+Platinum doublet chemotherapy

EXPERIMENTAL

Biological: NivolumabDrug: PemetrexedDrug: CisplatinDrug: Carboplatin

Nivolumab + Ipilimumab

EXPERIMENTAL

Enrollment is closed for this arm

Biological: NivolumabBiological: Ipilimumab

Platinum doublet chemotherapy

ACTIVE COMPARATOR

Drug: PemetrexedDrug: CisplatinDrug: Carboplatin