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

NCT02864251 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 367

Last updated 2023-09-28

Study results available
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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.

Conditions

  • Non-Small-Cell Lung Carcinoma

Interventions

BIOLOGICAL

Nivolumab

Specified dose on specified days

BIOLOGICAL

Ipilimumab

Specified dose on specified days

DRUG

Pemetrexed

Specified dose on specified days

DRUG

Cisplatin

Specified dose on specified days

DRUG

Carboplatin

Specified dose on specified days

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-17
Primary Completion
2022-01-20
Completion
2022-10-17
FDA Drug
Yes

Countries

  • United States
  • Canada
  • China
  • France
  • Hong Kong
  • Japan
  • Singapore
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02864251 on ClinicalTrials.gov