Clinical Trials/NCT04026412

NCT04026412

Completed

Phase 3

A Phase 3, Randomized, Open Label Study to Compare Nivolumab Plus Concurrent Chemoradiotherapy (CCRT) Followed by Nivolumab Plus Ipilimumab or Nivolumab Plus CCRT Followed by Nivolumab vs CCRT Followed by Durvalumab in Previously Untreated, Locally Advanced Non-small Cell Lung Cancer (LA NSCLC)

Bristol-Myers Squibb179 sites in 7 countries925 target enrollmentOctober 8, 2019

ConditionsNon-Small Cell Lung Cancer (NSCLC)

Interventionsnivolumab ipilimumab durvalumab

Drugsnivolumab ipilimumab durvalumab

Overview

Phase: Phase 3
Intervention: nivolumab
Conditions: Non-Small Cell Lung Cancer (NSCLC)
Sponsor: Bristol-Myers Squibb
Enrollment: 925
Locations: 179
Primary Endpoint: Arm A Vs Arm C - Progression-Free Survival (PFS) by RECIST 1.1 Per Blinded Independent Central Review (BICR)
Status: Completed
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary purpose of the study is to compare the effectiveness of nivolumab plus concurrent chemoradiotherapy (CCRT) followed by nivolumab plus ipilimumab vs CCRT followed by durvalumab in participants with untreated Locally Advanced Non-small Cell Lung Cancer (LA NSCLC).

Registry

clinicaltrials.gov

Start Date

October 8, 2019

End Date

November 26, 2024

Last Updated

9 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Eastern Cooperative Oncology Group (ECOG) performance status ≤1
•Locally advanced stage IIIA, IIIB, or IIIC (T1-2 N2-3 M0, T3 N1-3 M0, or T4 N0-3 M0) pathologically-confirmed NSCLC, according to 8th TNM classification. Participants who are not planned for potential curative surgical resection are eligible.
•Newly diagnosed and treatment-naïve, with no prior local or systemic anticancer therapy given as primary therapy for locally advanced disease

Exclusion Criteria

•Any condition including medical, emotional, psychiatric, or logistical that, in the opinion of the Investigator would preclude the participant from adhering to the protocol or would increase the risk associated with study participation
•Active infection requiring systemic therapy within 14 days prior to randomization
•History of organ or tissue transplant that requires systemic use of immune suppressive agents
•Prior thoracic radiotherapy
•Other protocol-defined inclusion/exclusion criteria apply

Arms & Interventions

Arm A: nivolumab + CCRT + ipilimumab

Concurrent chemoradiotherapy (CCRT)

Intervention: nivolumab

Arm A: nivolumab + CCRT + ipilimumab

Concurrent chemoradiotherapy (CCRT)

Intervention: ipilimumab

Arm B: nivolumab + CCRT

Concurrent chemoradiotherapy (CCRT)

Intervention: nivolumab

Arm C: CCRT + durvalumab

Concurrent chemoradiotherapy (CCRT)

Intervention: durvalumab

Outcomes

Primary Outcomes

Arm A Vs Arm C - Progression-Free Survival (PFS) by RECIST 1.1 Per Blinded Independent Central Review (BICR)

Time Frame: From randomization untill disease progression or death, whichever occurs first (up to approximately 53 months)

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.

Secondary Outcomes

Overall Survival (OS)(From randomization untill death (up to approximately 61 months))
Arm B Vs Arm C and Arm A Vs Arm B- Progression-Free Survival (Irrespective of Subsequent Therapy) by RECIST 1.1 Per Blinded Independent Central Review (BICR)(From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months))
Objective Response Rate (ORR) by BICR(From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months))
Duration of Response (DoR) by RECIST 1.1 Per BICR(From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months))
Time to Response (TTR) by RECIST 1.1 Per BICR(From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months))
Progression Free Survival (PFS) by RECIST 1.1 Per Investigator Assessment(From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months))
Objective Response Rate (ORR) by RECIST 1.1 Per Investigator Assessment(From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months))
Duration of Response (DOR) by RECIST 1.1 Per Investigator Assessment(From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months))
Time to Response (TTR) by RECIST 1.1 Per Investigator Assessment(From randomization untill disease progression or death, whichever occurs first (up to approximately 61 months))
Time to Death or Distant Metastases (TDDM)(From randomization until metastases or death, whichever occurs first (up to approximately 61 months))
Number of Participants With Adverse Events (AEs), Serious AEs and Select AEs(From first dose (Day 1) till 30 days after the last dose (up to approximately 19 months))
Change From Baseline in Non-small Cell Lung Cancer (NSCLC)-Symptom Assessment Questionnaire (SAQ) Total Score at Week 48(Baseline (Day 1) and Week 48)