Trial · NCT03373760

Durvalumab and Tremelimumab in Treating Patients With Recurrent Stage IV Lung Cancer

NCT03373760, Phase 2, Completed, SWOG Cancer Research Network; results first posted 2022-01-21

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Durvalumab and Tremelimumab in Treating Patients With Recurrent Stage IV Lung Cancer. Trials, record NCT03373760. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03373760

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Trial

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

Title: Durvalumab and Tremelimumab in Treating Patients With Recurrent Stage IV Lung Cancer
NCT number: NCT03373760
Status: Completed
Phases: Phase 2
Enrollment: 67 participants, actual
Lead sponsor: SWOG Cancer Research Network
Conditions: Recurrent Squamous Cell Lung Carcinoma, Stage IV Squamous Cell Lung Carcinoma AJCC v7
Interventions: Durvalumab, Laboratory Biomarker Analysis, Tremelimumab
First posted: 2017-12-14
Last updated: 2023-06-09
Results first posted: 2022-01-21

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Objective Response Rate	From date of registration to progression or treatment discontinuation, up to 2 years and 5.5 months.	Percentage of participants with confirmed or unconfirmed, complete or partial response to treatment with MEDI4736 (durvalumab) plus tremelimumab per Response Evaluation Criteria in Solid Tumors Criteria (RECIST 1.1). Complete Response (CR): 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 (PR): 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	Duration of Response (DoR) Among Patients Who Achieve a Complete Response (CR) or Partial Response (PR) (Confirmed and Unconfirmed) by RECIST 1.1.	From date of registration to maximum of 2 years and 5.5 months or death.	Time from date of first documentation of response (CR or PR) to date of first documentation of progression assessed by local review or symptomatic deterioration, or death from any cause among patients who achieve a response. Patients last known to be alive without report of progression are censored at date of last disease assessment. For patients with a missing scan (or consecutive missing scans) whose subsequent scan determines progression, the expected date of the first missing scan will be used as the date of progression. 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 and an absolute increase of at least 0.5 cm; Unequivocal progression of non-measurable disease in the opinion of the treating physician (explanation must be provided); Appearance of any new lesion/site; Death due to disease without prior documentation of progression and without symptomatic deterioration
Secondary	Duration of Response (DoR) Per Immune-related Response Criteria Among Patients Who Achieve a Complete Response (CR) or Partial Response (PR) (Confirmed and Unconfirmed) by RECIST 1.1	From date of registration to maximum of 2 years and 5.5 months or death	Time from date of first documentation of response (CR or PR) to date of first documentation of irRC-progression assessed by local review or symptomatic deterioration, or death due to any cause. Patients last known to be alive without report of irRC-progression are censored at date of last disease assessment. For patients with a missing scan (or consecutive missing scans) whose subsequent scan(s) determine irRC-progression, the date of irRCprogression will be the expected date of the first missing scan (as defined by the disease assessment schedule) or the date of the first scan documenting potential irRC-progression, whichever is earliest.
Secondary	Overall Survival (OS) Among Patients Treated With MEDI4736 (Durvalumab) Plus Tremelimumab	Date of registration to maximum of 2 years and 5.5 months or death.	Time from date of sub-study registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Secondary	Investigator-assessed Progression-free Survival (IA-PFS) Among Patients Treated With MEDI4736 (Durvalumab) Plus Tremelimumab.	From date of registration to maximum 2 years and 5.5 months or death.	Time from date of sub-study registration to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause. Patients last known to be alive without report of progression are censored at date of last disease assessment. For patients with a missing scan (or consecutive missing scans) whose subsequent scan determines progression, the expected date of the first missing scan (as defined by the disease assessment schedule) was used as the date of progression. 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 and 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	Investigator-assessed Progression-free Survival (IA-PFS) Assessed by Immune-related Response Criteria (irRC-IA-PFS) Among Patients Treated With MEDI4736 (Durvalumab) Plus Tremelimumab	Date of registration to maximum of 2 years and 5.5 months or death	Time from date of sub-study registration to date of first documentation of progression assessed by local review or symptomatic deterioration, or death due to any cause. Patients last known to be alive without report of progression are censored at date of last disease assessment. For patients with a missing scan (or consecutive missing scans) whose subsequent scan determines progression, the expected date of the first missing scan (as defined by the disease assessment schedule) will be used as the date of progression. irRC-progression is defined by progression per RECIST 1.1 except that progression determined by appearance of new lesions or by a 20% increase in the sum of diameters must be confirmed by a second consecutive determination of progression at least 28 days from the date of initial documentation of progression.
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 2 years and 5.5 months 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 serious adverse events (SAEs).

Source ClinicalTrials.gov

Outcomes7

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Objective Response Rate	From date of registration to progression or treatment discontinuation, up to 2 years and 5.5 months.	Eligible and evaluable participants	percentage of participants	NUMBER
SECONDARY	Duration of Response (DoR) Among Patients Who Achieve a Complete Response (CR) or Partial Response (PR) (Confirmed and Unconfirmed) by RECIST 1.1.	From date of registration to maximum of 2 years and 5.5 months or death.	Eligible and evaluable participants.	months	NUMBER
SECONDARY	Duration of Response (DoR) Per Immune-related Response Criteria Among Patients Who Achieve a Complete Response (CR) or Partial Response (PR) (Confirmed and Unconfirmed) by RECIST 1.1	From date of registration to maximum of 2 years and 5.5 months or death	Data were not collected for this outcome.
SECONDARY	Overall Survival (OS) Among Patients Treated With MEDI4736 (Durvalumab) Plus Tremelimumab	Date of registration to maximum of 2 years and 5.5 months or death.	Eligible and evaluable participants	months	MEDIAN
SECONDARY	Investigator-assessed Progression-free Survival (IA-PFS) Among Patients Treated With MEDI4736 (Durvalumab) Plus Tremelimumab.	From date of registration to maximum 2 years and 5.5 months or death.	Eligible and evaluable participants	months	MEDIAN
SECONDARY	Investigator-assessed Progression-free Survival (IA-PFS) Assessed by Immune-related Response Criteria (irRC-IA-PFS) Among Patients Treated With MEDI4736 (Durvalumab) Plus Tremelimumab	Date of registration to maximum of 2 years and 5.5 months or death	Data were not collected for this outcome.
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 2 years and 5.5 months post registration	Participants who received at least one dose of protocol treatment	Participants	NUMBER

Source ClinicalTrials.gov

Results by group32

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

Outcome	Group	Category	Value	Spread	Units
Objective Response Rate	Primary PD-(L)1 Resistance Cohort		7	95% Confidence Interval 0 to 17	percentage of participants
Objective Response Rate	Acquired PD-(L)1 Resistance Cohort		0	95% Confidence Interval NA to NA	percentage of participants
Duration of Response (DoR) Among Patients Who Achieve a Complete Response (CR) or Partial Response (PR) (Confirmed and Unconfirmed) by RECIST 1.1.	Treatment (Tremelimumab, Durvalumab)	Duration of response for the first responding patient in the primary resistance cohort	8.5		months
Duration of Response (DoR) Among Patients Who Achieve a Complete Response (CR) or Partial Response (PR) (Confirmed and Unconfirmed) by RECIST 1.1.	Treatment (Tremelimumab, Durvalumab)	Duration of response for the second responding patient in the primary resistance cohort	5.9		months
Overall Survival (OS) Among Patients Treated With MEDI4736 (Durvalumab) Plus Tremelimumab	Primary PD-(L)1 Resistance Cohort		7.7	95% Confidence Interval 4.0 to 12.0	months
Overall Survival (OS) Among Patients Treated With MEDI4736 (Durvalumab) Plus Tremelimumab	Acquired PD-(L)1 Resistance Cohort		7.6	95% Confidence Interval 5.3 to 10.2	months
Investigator-assessed Progression-free Survival (IA-PFS) Among Patients Treated With MEDI4736 (Durvalumab) Plus Tremelimumab.	Primary PD-(L)1 Resistance Cohort		2.0	95% Confidence Interval 1.6 to 3.0	months
Investigator-assessed Progression-free Survival (IA-PFS) Among Patients Treated With MEDI4736 (Durvalumab) Plus Tremelimumab.	Acquired PD-(L)1 Resistance Cohort		2.1	95% Confidence Interval 1.6 to 3.2	months
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	MEDI4736 + Tremelimumab	Atrial fibrillation	1		Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs	MEDI4736 + Tremelimumab	Atrial flutter	1		Participants

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Treatment (Tremelimumab, Durvalumab)	58
Overall Study	COMPLETED	Treatment (Tremelimumab, Durvalumab)	0
Overall Study	NOT COMPLETED	Treatment (Tremelimumab, Durvalumab)	58

Source ClinicalTrials.gov

Adverse events123

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	MEDI4736 + Tremelimumab	24	58
other	Atrial fibrillation	Cardiac disorders	MEDI4736 + Tremelimumab	3	58
other	Endocrine disorders-Other	Endocrine disorders	MEDI4736 + Tremelimumab	3	58
other	Hypothyroidism	Endocrine disorders	MEDI4736 + Tremelimumab	5	58
other	Abdominal pain	Gastrointestinal disorders	MEDI4736 + Tremelimumab	5	58
other	Constipation	Gastrointestinal disorders	MEDI4736 + Tremelimumab	7	58
other	Diarrhea	Gastrointestinal disorders	MEDI4736 + Tremelimumab	12	58
other	Dysphagia	Gastrointestinal disorders	MEDI4736 + Tremelimumab	5	58
other	Nausea	Gastrointestinal disorders	MEDI4736 + Tremelimumab	16	58
other	Vomiting	Gastrointestinal disorders	MEDI4736 + Tremelimumab	10	58

1 to 10 of 123Source ClinicalTrials.gov

See all 123 adverse events

Adverse event totals3

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	MEDI4736 + Tremelimumab	47	58
Total, other adverse events	MEDI4736 + Tremelimumab	58	58
Total, serious adverse events	MEDI4736 + Tremelimumab	36	58

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34429332	DERIVED

Source 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 comparisons0

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

None in this release.

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/NCT03373760

GET https://conductscience.org/api/trials/v1/NCT03373760/results?page=2

API reference For AI assistants