Phase 2 N=341 Randomized Treatment

A Study of Nivolumab in Advanced Non-Small Cell Lung Cancer (NSCLC)

Non-Small Cell Lung Cancer

Bottom Line

View on ClinicalTrials.gov: NCT02574078 ↗

Enrolled (actual)

341

Serious AEs

45.6%

Results posted

May 2021

Primary outcome: Primary: Progression-Free Survival (PFS), Groups A-D Only — 15.0; 6.7; 6.0; 5.9 Months — p=0.5050

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Nivolumab (Drug); Bevacizumab (Drug); Pemetrexed (Drug); Best Supportive Care (Other); nab-Paclitaxel (Drug); Paclitaxel (Drug); Docetaxel (Drug); Gemcitabine (Drug); Erlotinib (Drug); Crizotinib (Drug); Carboplatin (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Bristol-Myers Squibb
Primary completion: Apr 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Progression-Free Survival (PFS), Groups A-D Only	15.0; 6.7; 6.0; 5.9; 8.1; 5.0	0.5050
PRIMARY Overall Survival (OS), Groups A-C Only	20.0; 30.8; 18.1; 28.9; 17.4; 18.4	0.9951
PRIMARY Percentage of Participants With Treatment-related Adverse Events (AEs) Leading to Both Study Drugs Discontinuation, Group E Only	38.5	—
SECONDARY Duration of Response (DOR), Groups A-D Only	12.780; NA; 17.084; 12.912; 8.542; 14.982	—
SECONDARY Objective Response Rate (ORR), Groups A-E	23.1; 16.7; 12.5; 29.4; 21.2; 3.1	—
SECONDARY Overall Survival (OS), Group D Only	NA; 34.8	0.2862
SECONDARY Progression-Free Survival (PFS), Group E Only	9.63	—

Summary

The purpose of this study is to determine whether nivolumab monotherapy or in combination with Standard of care (SOC) therapies will provide clinical benefit (i.e., PFS, OS, and DOR) without unacceptable toxicity in advanced Non-Small Cell Lung Cancer patients.

Eligibility Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria

Histologically confirmed locally advanced or stage IV NSCLC
Eastern Cooperative Oncology Group (ECOG) Performance status (PS) 0-2
Tumor tissue sections must be available for biomarker evaluation

Exclusion Criteria

Untreated or active/progressing Central Nervous system (CNS) metastases
Active, known or suspected autoimmune disease
Known history of testing positive for HIV or AIDS
Active or chronic infection of hepatitis B virus or hepatitis C

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02574078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.