Trial · NCT02785952

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, Phase 3, Active not recruiting, SWOG Cancer Research Network; results first posted 2022-01-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT02785952. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02785952

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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
NCT number: NCT02785952
Status: Active not recruiting
Phases: Phase 3
Enrollment: 275 participants, actual
Lead sponsor: SWOG Cancer Research Network
Conditions: Recurrent Squamous Cell Lung Carcinoma, Stage IV Squamous Cell Lung Carcinoma AJCC v7
Interventions: Ipilimumab, Laboratory Biomarker Analysis, Nivolumab, Quality-of-Life Assessment, Questionnaire Administration
First posted: 2016-05-30
Last updated: 2026-06-09
Results first posted: 2022-01-11

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Survival	From date of registration to maximum of 3 years or death	Duration from randomization to death due to any cause
Secondary	Investigator-assessed Progression-free Survival (IA-PFS)	From date of registration to maximum of 3 years or death	Duration from randomization to first occurrence of progression by RECIST 1.1, symptomatic deterioration, or death due to any cause. The IA-PFS for patients last known to be alive and free of progression or symptomatic deterioration was censored at the date of last disease assessment. Progression is defined as one or more of the following: 20% increase in the sum of appropriate diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline as well as an absolute increase of at least 0.5 cm; Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided); Appearance of any new lesion/site; Death due to disease without prior documentation of progression and without symptomatic deterioration
Secondary	Objective Response Rate	From date of registration to maximum of 3 years or death	Response was defined as the occurrence of a complete or partial response, confirmed or unconfirmed per RECIST 1.1 criteria. Response for patients not known to have a response was coded as nonresponse. Complete response: Complete disappearance of all target and non-target lesions. No new lesions. No disease related symptoms. Any lymph nodes (whether target or non-target) must have reduction in short axis to \< 1.0 cm. All disease must be assessed using the same technique as baseline. Partial response: Applies only to patients with at least one measurable lesion. Greater than or equal to 30% decrease under baseline of the sum of appropriate diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. All target measurable lesions must be assessed using the same techniques as baseline.
Secondary	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	Only adverse events that are possibly, probably or definitely related to study drug are reported. CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for reporting SAEs.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival	From date of registration to maximum of 3 years or death	Eligible and evaluable participants	months	MEDIAN
SECONDARY	Investigator-assessed Progression-free Survival (IA-PFS)	From date of registration to maximum of 3 years or death	Eligible and evaluable participants	months	MEDIAN
SECONDARY	Objective Response Rate	From date of registration to maximum of 3 years or death	Eligible and evaluable participants	percentage of participants	NUMBER
SECONDARY	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	Participants who received at least one dose of protocol treatment	Participants	NUMBER

Source ClinicalTrials.gov

Results by group154

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Overall Survival	Arm I (Nivolumab, Ipilimumab)		10	95% Confidence Interval 8.0 to 14.4	months
Overall Survival	Arm II (Nivolumab)		11	95% Confidence Interval 8.6 to 13.7	months
Investigator-assessed Progression-free Survival (IA-PFS)	Arm I (Nivolumab, Ipilimumab)		3.8	95% Confidence Interval 2.7 to 4.4	months
Investigator-assessed Progression-free Survival (IA-PFS)	Arm II (Nivolumab)		2.9	95% Confidence Interval 1.8 to 4.0	months
Objective Response Rate	Arm I (Nivolumab, Ipilimumab)		18	95% Confidence Interval 12 to 25	percentage of participants
Objective Response Rate	Arm II (Nivolumab)		17	95% Confidence Interval 10 to 23	percentage of participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Nivolumab + Ipilimumab	Abdominal pain	1		Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Nivolumab	Abdominal pain	0		Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Nivolumab + Ipilimumab	Acute kidney injury	1		Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Nivolumab	Acute kidney injury	1		Participants

1 to 10 of 154Source ClinicalTrials.gov

See all 154 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I (Nivolumab, Ipilimumab)	125
Overall Study	STARTED	Arm II (Nivolumab)	127
Overall Study	COMPLETED	Arm I (Nivolumab, Ipilimumab)	0
Overall Study	COMPLETED	Arm II (Nivolumab)	0
Overall Study	NOT COMPLETED	Arm I (Nivolumab, Ipilimumab)	125
Overall Study	NOT COMPLETED	Arm II (Nivolumab)	127

Source ClinicalTrials.gov

Adverse events440

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anemia	Blood and lymphatic system disorders	Nivolumab + Ipilimumab	58	124
other	Anemia	Blood and lymphatic system disorders	Nivolumab	48	123
other	Sinus tachycardia	Cardiac disorders	Nivolumab + Ipilimumab	11	124
other	Sinus tachycardia	Cardiac disorders	Nivolumab	6	123
other	Hyperthyroidism	Endocrine disorders	Nivolumab + Ipilimumab	14	124
other	Hyperthyroidism	Endocrine disorders	Nivolumab	10	123
other	Hypothyroidism	Endocrine disorders	Nivolumab + Ipilimumab	23	124
other	Hypothyroidism	Endocrine disorders	Nivolumab	18	123
other	Blurred vision	Eye disorders	Nivolumab + Ipilimumab	9	124
other	Blurred vision	Eye disorders	Nivolumab	5	123

1 to 10 of 440Source ClinicalTrials.gov

See all 440 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nivolumab + Ipilimumab	92	125
Total, all-cause mortality	Nivolumab	105	127
Total, other adverse events	Nivolumab + Ipilimumab	122	124
Total, other adverse events	Nivolumab	123	123
Total, serious adverse events	Nivolumab + Ipilimumab	78	124
Total, serious adverse events	Nivolumab	58	123

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
34264316	DERIVED	PubMed
37084329	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA180888	SWOG Network Group Operations Center of the NCTN	LARA, PRIMO N.; HERSHMAN, DAWN	UNIVERSITY OF CALIFORNIA AT DAVIS	NATIONAL CANCER INSTITUTE	2014 to 2026

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Nivolumab + Ipilimumab vs Nivolumab: deaths from any cause	Trial comparisons
Nivolumab + Ipilimumab vs Nivolumab: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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