Brief Summary

The purpose of this study is to show that Nivolumab will improve progression free survival in subjects with strongly Stage IV or Recurrent PD-L1+ non-small cell lung cancer when compared to chemotherapy

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

541

participants targeted

Target at P75+ for phase_3

Timeline

Completed

Started Mar 2014

Longer than P75 for phase_3

Geographic Reach

25 countries

139 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

8.2 years study duration

First Submitted

Initial submission to the registry

January 19, 2014

Completed

3 days until next milestone

First Posted

Study publicly available on registry

January 22, 2014

Completed

2 months until next milestone

Study Start

First participant enrolled

March 27, 2014

Completed

2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

July 26, 2017

Completed

4.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2022

Completed

Last Updated

March 2, 2023

Status Verified

February 1, 2023

Enrollment Period

2.3 years

First QC Date

January 19, 2014

Results QC Date

June 26, 2017

Last Update Submit

February 2, 2023

Conditions

Stage IV or Recurrent Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

Progression-Free Survival in Participants With PD-L1 Expression >= 5%
Progression-Free Survival (PFS) was defined as the time between the date of randomization and the first date of documented tumor progression, as determined by the Independent Radiology Review Committee (IRRC) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, or death due to any cause, whichever occurs first. Participants who die without a reported progression were considered to have progressed on the date of their death. Participants who did not progress or die were censored on the date of their last evaluable tumor assessment. Participants who did not have any on-study tumor assessments and did not die were censored on the day they were randomized. Participants who received subsequent anti-cancer therapy prior to documented progression were censored at the last evaluable tumor assessment prior to the initiation of new therapy.
From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)

Secondary Outcomes (5)

Progression-Free Survival in All Randomized Participants
From date of randomization until date of documented tumor progression (assessed up to August 2016, approximately 28 months)
Overall Survival in Participants With PD-L1 Expression >= 5%
From date of randomization to date of death (up to approximately 89 months)
Overall Survival in All Randomized Participants
From date of randomization to date of death (up to approximately 89 months)
Objective Response Rate (ORR) in Participants With PD-L1 Expression >= 5%
From date of randomization until date of documented tumor progression or subsequent anti-cancer therapy, whichever occurs first (assessed up to August 2016, approximately 28 months)
Disease-related Symptom Improvement Rate by Week 12
From date of randomization to week 12

Study Arms (2)

Arm A: Nivolumab subjects

EXPERIMENTAL

Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure

Biological: Nivolumab

Arm B: Investigator's Choice Chemotherapy

ACTIVE COMPARATOR

Investigator's Choice Chemotherapy administered in 3-week cycles up to a maximum of 6 cycles of Intravenous injection until disease progression, unacceptable toxicity or completion of the 6 cycles, whichever comes first Squamous subjects: * Gemcitabine 1250 mg/mg(2) administered on Day 1 and Day 8 with Cisplatin 75 mg/m(2) administered on Day 1 of each cycle; or * Gemcitabine 1000 mg/mg(2) administered on Day 1 and Day 8 with Carboplatin (AUC 5) administered on Day 1 of each cycle; or * Paclitaxel 200 mg/m(2) with Carboplatin (AUC 6) administered on Day 1 of each cycle Non-Squamous subjects: * Pemetrexed 500 mg/m(2) with Cisplatin 75 mg/m(2) administered on Day 1 of each cycle * Pemetrexed 500 mg/m(2) Carboplatin (AUC 6) administered on Day 1 of each cycle Optional crossover: * Nivolumab solution for Injection 3 mg/kg Intravenous every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent or study closure

Biological: NivolumabDrug: GemcitabineDrug: CisplatinDrug: CarboplatinDrug: PaclitaxelDrug: Pemetrexed

Interventions

NivolumabBIOLOGICAL

Also known as: BMS-936558, MDX-1106

Arm A: Nivolumab subjectsArm B: Investigator's Choice Chemotherapy

GemcitabineDRUG

Also known as: Gemzar