NCT02785952|Active Not RecruitingPhase 3Results

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

A Phase III Randomized Study of Nivolumab Plus Ipilimumab Versus Nivolumab for Previously Treated Patients With Stage IV Squamous Cell Lung Cancer and No Matching Biomarker (Lung-Map Sub-Study)

SWOG Cancer Research Network ClinicalTrials.gov

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3 other identifiers

S1400INCI-2016-00050U10CA180888

Study Type

interventional

Target

275

Locations

2 countries

Sites

1207

Timeline

RegisteredMay 2016

StartedDec 2015

CompletionApr 2026

Brief 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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

275

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Dec 2015

Longer than P75 for phase_3

Geographic Reach

2 countries

1207 active sites

Status

active not recruiting

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

10.3 years study duration

Study Start

First participant enrolled

December 29, 2015

Completed

5 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2016

Completed

5 days until next milestone

First Posted

Study publicly available on registry

May 30, 2016

Completed

3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2019

Completed

2.1 years until next milestone

Results Posted

Study results publicly available

January 11, 2022

Completed

4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed

Last Updated

May 21, 2025

Status Verified

May 1, 2025

Enrollment Period

4 years

First QC Date

May 25, 2016

Results QC Date

November 8, 2021

Last Update Submit

May 12, 2025

Conditions

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

Outcome Measures

Primary Outcomes (1)

Overall Survival
Duration from randomization to death due to any cause
From date of registration to maximum of 3 years or death

Secondary Outcomes (3)

Investigator-assessed Progression-free Survival (IA-PFS)
From date of registration to maximum of 3 years or death
Objective Response Rate
From date of registration to maximum of 3 years or death
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Duration of treatment and follow up until death or 3 years post registration

Study Arms (2)

Arm I (nivolumab, ipilimumab)

EXPERIMENTAL

Patients receive nivolumab IV over 30 minutes on day 1 and ipilimumab IV over 60 minutes on day 1 of every third course (every 42 days). Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Biological: IpilimumabOther: Laboratory Biomarker AnalysisBiological: NivolumabOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Arm II (nivolumab)

ACTIVE COMPARATOR

Patients receive nivolumab IV over 30 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.

Other: Laboratory Biomarker AnalysisBiological: NivolumabOther: Quality-of-Life AssessmentOther: Questionnaire Administration

Interventions

IpilimumabBIOLOGICAL

Given IV

Also known as: Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, MDX-010, MDX-CTLA4, Yervoy

Arm I (nivolumab, ipilimumab)

Laboratory Biomarker AnalysisOTHER

Correlative studies

Arm I (nivolumab, ipilimumab)Arm II (nivolumab)

NivolumabBIOLOGICAL

Given IV

Also known as: BMS-936558, MDX-1106, NIVO, ONO-4538, Opdivo

Arm I (nivolumab, ipilimumab)Arm II (nivolumab)

Quality-of-Life AssessmentOTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (nivolumab, ipilimumab)Arm II (nivolumab)

Questionnaire AdministrationOTHER

Ancillary studies

Arm I (nivolumab, ipilimumab)Arm II (nivolumab)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients must meet all SCREENING/PRE-SCREENING and SUB-STUDY REGISTRATION COMMON ELIGIBILITY CRITERIA as specified in S1400: Phase II/III Biomarker-Driven Master Protocol for Previously Treated Squamous Cell Lung Cancer (Lung-Map)
Patients must have been assigned to S1400I
Patients must not have had prior treatment with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-cytotoxic T-lymphocyte-associated protein (CTLA)-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways
Patients must not have an active, known, or suspected autoimmune disease; patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger
Patients must not have any known allergy or reaction to any component of the nivolumab and ipilimumab formulations
Patients must not have received systemic treatment with corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days prior to sub-study registration; inhaled or topical steroids, and adrenal replacement doses =\< 10 mg daily prednisone or equivalent are permitted in the absence of active autoimmune disease
Patients must not have a known positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection; patients with a positive hepatitis C antibody with a negative viral load are allowed
Patients must not have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
Patients must not have interstitial lung disease that is symptomatic or disease that may interfere with the detection or management of suspected drug-related pulmonary toxicity
Patients must also be offered participation in banking for future use of specimens
Patients must have a lipase, amylase, TSH with reflex free T3/T4 performed within 7 days prior to sub-study registration
Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, and myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
Patients with a history of congestive heart failure (CHF) or at risk because of underlying cardiovascular disease or exposure to cardiotoxic drug should have an electrocardiogram (EKG) and echocardiogram performed to evaluate cardiac function as clinically indicated
Patients with evidence of congestive heart failure (CHF), myocardial infarction (MI), cardiomyopathy, or myositis should have a cardiac evaluation including lab tests and cardiology consultations as clinically indicated including EKG, creatine phosphokinase (CPK), troponin, and echocardiogram
Patients who can complete Patient Reported Outcomes (PRO) forms in English are required to complete a pre-study S1400I Patient Reported Outcomes (PRO) Questionnaire and a pre-study S1400I European Quality of Life Five Dimension (EQ-5D) Questionnaire within 14 days prior to registration; NOTE: Patients enrolled to S1400I prior to 9/1/2016 are not eligible for the PRO study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

SWOG Cancer Research Networklead
National Cancer Institute (NCI)collaborator

Study Sites (1207)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

Location

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508, United States

Location

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504, United States

Location

Alaska Breast Care and Surgery LLC