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Lung-MAP: Nivolumab With or Without Ipilimumab as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and No Matching Biomarkers

NCT02785952 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2025-05-21

Study results available
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Summary

This randomized phase III trial compares nivolumab with ipilimumab and nivolumab alone in treating patients with stage IV squamous cell lung cancer that has come back after previous treatment. This is a "non-match" sub-study that includes all screened patients not eligible for a biomarker-driven sub-study. Monoclonal antibodies, such as nivolumab and ipilimumab, may be able to shrink tumors. It is not yet known whether nivolumab works better with or without ipilimumab in treating patients with squamous cell lung cancer.

Conditions

  • Recurrent Squamous Cell Lung Carcinoma
  • Stage IV Squamous Cell Lung Carcinoma AJCC v7

Interventions

BIOLOGICAL

Ipilimumab

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Nivolumab

Given IV

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • SWOG Cancer Research Network

    lead NETWORK

Principal Investigators

  • Vassiliki Papadimitrakopoulou · SWOG Cancer Research Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-12-29
Primary Completion
2019-12-19
Completion
2026-04-01

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs

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 NCT02785952 on ClinicalTrials.gov