Trial · NCT02766335

Lung-MAP: Durvalumab as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and No Matching Biomarkers

NCT02766335, Phase 2, Phase 3, Completed, SWOG Cancer Research Network; results first posted 2021-12-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Lung-MAP: Durvalumab as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and No Matching Biomarkers. Trials, record NCT02766335. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02766335

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Trial

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

Title: Lung-MAP: Durvalumab as Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer and No Matching Biomarkers
NCT number: NCT02766335
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 116 participants, actual
Lead sponsor: SWOG Cancer Research Network
Conditions: Recurrent Squamous Cell Lung Carcinoma, Stage IV Squamous Cell Lung Carcinoma AJCC v7
Interventions: Docetaxel, Durvalumab, Laboratory Biomarker Analysis
First posted: 2016-05-09
Last updated: 2023-05-25
Results first posted: 2021-12-30

Source ClinicalTrials.gov

Registered outcomes15

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

List	Outcome	Time frame	Description
Primary	Response Rate in MEDI4736-treated Participants	Up to 3 years post registration	The percentage of participants with confirmed and unconfirmed, partial response and complete response to treatment with MEDI4736 per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Primary	Overall Response Rate Among PD-L1 Positive Participants Treated With MEDI4736	Up to 3 years post registration	The percentage of PD-L1 positive participants with confirmed and unconfirmed, partial response and complete response to treatment with MEDI4736 per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Secondary	Investigator-assessed Progression-free Survival in Participants Treated With MEDI4736	Up to 3 years post registration	Duration from date of sub-study registration to date of first documentation of progression, per RECIST 1.1, assessed by local review or symptomatic deterioration, or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions or an absolute increase of \>= 0.5cm, or a measurable increase in a non-target lesion, or the appearance of new lesions or death due to disease without prior documentation of progression or symptomatic deterioration.
Secondary	Investigator-assessed Progression-free Survival in PD-L1 Positive Participants Treated With MEDI4736	up to 3 years post registration	Duration from date of sub-study registration to date of first documentation of progression, per RECIST 1.1, assessed by local review or symptomatic deterioration or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions or an absolute increase of \>= 0.5cm, or a measurable increase in a non-target lesion, or the appearance of new lesions or death due to disease without prior documentation of progression or symptomatic deterioration.
Secondary	Overall Survival in MEDI4736-treated Participants	Up to 3 years post-registration	Duration from date of sub-study registration (or date of screening/pre-screening registration if patient never enrolls in a sub-study) to date of death due to any cause.
Secondary	Overall Survival in PD-L1 Positive MEDI4736-treated Participants	up to 3 years post registration	Duration from date of sub-study registration (or date of screening/pre-screening registration if patient never enrolls in a sub-study) to date of death due to any cause.
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	Adverse Events (AEs) are reported by CTCAE Version 5.0 for serious adverse events only and CTCAE Version 4.0 for routine toxicity reporting. Only adverse events that are possibly, probably or definitely related to study drug are reported.
Secondary	Investigator-assessed Progression-free Survival Assessed Using a Modified Response Criteria Adapted for Immunotherapy in Participants Treated With MEDI4736	up to 3 years post registration	Duration from date of sub-study registration to date of first documentation of immune related response criteria-progression assessed by local review or symptomatic deterioration (as defined above), or death due to any cause
Secondary	Investigator-assessed Progression-free Survival Assessed Using a Modified Response Criteria Adapted for Immunotherapy in PD-L1 Positive Participants Treated With MEDI4736	up to 3 years post registration	Duration from date of sub-study registration to date of first documentation of immune related response criteria-progression assessed by local review or symptomatic deterioration (as defined above), or death due to any cause
Secondary	Overall Survival	Up to 3 years post registration	Duration from date of sub-study registration (or date of screening/pre-screening registration if participant never enrolls in a sub-study) to date of death due to any cause. Note: The docetaxel arm was closed early due to removal of docetaxel as standard of care treatment. The analyses has been restricted to participants randomized to both arms before the docetaxel arm closed.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Response Rate in MEDI4736-treated Participants	Up to 3 years post registration	Eligible and evaluable participants	percentage of participants	NUMBER
PRIMARY	Overall Response Rate Among PD-L1 Positive Participants Treated With MEDI4736	Up to 3 years post registration	PD-L1 positive participants treated with MEDI4736	percentage of participants	NUMBER
SECONDARY	Investigator-assessed Progression-free Survival in Participants Treated With MEDI4736	Up to 3 years post registration	Eligible and evaluable participants	months	MEDIAN
SECONDARY	Investigator-assessed Progression-free Survival in PD-L1 Positive Participants Treated With MEDI4736	up to 3 years post registration	Eligible and evaluable PD-L1 positive participants	months	MEDIAN
SECONDARY	Overall Survival in MEDI4736-treated Participants	Up to 3 years post-registration	Eligible and evaluable participants	months	MEDIAN
SECONDARY	Overall Survival in PD-L1 Positive MEDI4736-treated Participants	up to 3 years post registration	Eligible and evaluable PD-L1 positive participants	months	MEDIAN
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
SECONDARY	Investigator-assessed Progression-free Survival Assessed Using a Modified Response Criteria Adapted for Immunotherapy in Participants Treated With MEDI4736	up to 3 years post registration	No data collected for this outcome measure
SECONDARY	Investigator-assessed Progression-free Survival Assessed Using a Modified Response Criteria Adapted for Immunotherapy in PD-L1 Positive Participants Treated With MEDI4736	up to 3 years post registration	No data collected for this outcome measure
SECONDARY	Overall Survival	Up to 3 years post registration	Eligible and evaluable participants enrolled before docetaxel arm closed	months	MEDIAN

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group82

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

Outcome	Group	Category	Value	Spread	Units
Response Rate in MEDI4736-treated Participants	Arm I (MEDI4736 - Closed to Accrual 12/2015)		16	95% Confidence Interval 7 to 25	percentage of participants
Overall Response Rate Among PD-L1 Positive Participants Treated With MEDI4736	Arm I (MEDI4736 - Closed to Accrual 12/2015)		14	95% Confidence Interval 0 to 33	percentage of participants
Investigator-assessed Progression-free Survival in Participants Treated With MEDI4736	Arm I (MEDI4736 - Closed to Accrual 12/2015)		2.9	95% Confidence Interval 2.0 to 4.0	months
Investigator-assessed Progression-free Survival in PD-L1 Positive Participants Treated With MEDI4736	Arm I (MEDI4736 - Closed to Accrual 12/2015)		2.3	95% Confidence Interval 1.4 to 4.2	months
Overall Survival in MEDI4736-treated Participants	Arm I (MEDI4736 - Closed to Accrual 12/2015)		11.6	95% Confidence Interval 10.2 to 14.3	months
Overall Survival in PD-L1 Positive MEDI4736-treated Participants	Arm I (MEDI4736 - Closed to Accrual 12/2015)		10.7	95% Confidence Interval 9.2 to 14.3	months
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Arm I (MEDI4736 - Closed to Accrual 12/2015)	Abdominal pain	1		Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Arm II (Docetaxel - Closed to Accrual 4/2015)	Abdominal pain	0		Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Arm I (MEDI4736 - Closed to Accrual 12/2015)	Alanine aminotransferase increased	2		Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	Arm II (Docetaxel - Closed to Accrual 4/2015)	Alanine aminotransferase increased	1		Participants

1 to 10 of 82Source ClinicalTrials.gov

See all 82 results by group

Participant flow21

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

Period	Milestone	Group	Participants
Initial Registration	STARTED	Arm I (MEDI4736 - Closed to Accrual 12/2015)	68
Initial Registration	STARTED	Arm II (Docetaxel - Closed to Accrual 4/2015)	30
Initial Registration	STARTED	Arm III - MEDI4736 Retreatment	0
Initial Registration	Eligible Participants Enrolled Before Docetaxel Arm Closed	Arm I (MEDI4736 - Closed to Accrual 12/2015)	32
Initial Registration	Eligible Participants Enrolled Before Docetaxel Arm Closed	Arm II (Docetaxel - Closed to Accrual 4/2015)	30
Initial Registration	Eligible Participants Enrolled Before Docetaxel Arm Closed	Arm III - MEDI4736 Retreatment	0
Initial Registration	COMPLETED	Arm I (MEDI4736 - Closed to Accrual 12/2015)	10
Initial Registration	COMPLETED	Arm II (Docetaxel - Closed to Accrual 4/2015)	0
Initial Registration	COMPLETED	Arm III - MEDI4736 Retreatment	0
Initial Registration	NOT COMPLETED	Arm I (MEDI4736 - Closed to Accrual 12/2015)	58

1 to 10 of 21Source ClinicalTrials.gov

See all 21 participant flow

Adverse events488

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	Arm I & Arm III (Initial Treatment and Retreatment With MEDI4736)	22	68
other	Anemia	Blood and lymphatic system disorders	Arm II (Docetaxel - Closed to Accrual 4/2015)	19	30
other	Blood and lymphatic system disorders - Other	Blood and lymphatic system disorders	Arm I & Arm III (Initial Treatment and Retreatment With MEDI4736)	1	68
other	Blood and lymphatic system disorders - Other	Blood and lymphatic system disorders	Arm II (Docetaxel - Closed to Accrual 4/2015)	0	30
other	Febrile neutropenia	Blood and lymphatic system disorders	Arm I & Arm III (Initial Treatment and Retreatment With MEDI4736)	0	68
other	Febrile neutropenia	Blood and lymphatic system disorders	Arm II (Docetaxel - Closed to Accrual 4/2015)	4	30
other	Leukocytosis	Blood and lymphatic system disorders	Arm I & Arm III (Initial Treatment and Retreatment With MEDI4736)	1	68
other	Leukocytosis	Blood and lymphatic system disorders	Arm II (Docetaxel - Closed to Accrual 4/2015)	0	30
other	Atrial fibrillation	Cardiac disorders	Arm I & Arm III (Initial Treatment and Retreatment With MEDI4736)	1	68
other	Atrial fibrillation	Cardiac disorders	Arm II (Docetaxel - Closed to Accrual 4/2015)	0	30

1 to 10 of 488Source ClinicalTrials.gov

See all 488 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I & Arm III (Initial Treatment and Retreatment With MEDI4736)	58	68
Total, all-cause mortality	Arm II (Docetaxel - Closed to Accrual 4/2015)	26	30
Total, other adverse events	Arm I & Arm III (Initial Treatment and Retreatment With MEDI4736)	66	68
Total, other adverse events	Arm II (Docetaxel - Closed to Accrual 4/2015)	30	30
Total, serious adverse events	Arm I & Arm III (Initial Treatment and Retreatment With MEDI4736)	27	68
Total, serious adverse events	Arm II (Docetaxel - Closed to Accrual 4/2015)	3	30

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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
Arm I & Arm III (Initial Treatment and Retreatment With MEDI4736) vs Arm II (Docetaxel - Closed to Accrual 4/2015): deaths from any cause	Trial comparisons
Arm I & Arm III (Initial Treatment and Retreatment With MEDI4736) vs Arm II (Docetaxel - Closed to Accrual 4/2015): 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.

GET https://conductscience.org/api/trials/v1/NCT02766335

GET https://conductscience.org/api/trials/v1/NCT02766335/results?page=2

API reference For AI assistants