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

• ClinicalTrials.gov Identifier: NCT03373760
• Recruitment Status: Completed
• First Posted: December 14, 2017
• Results First Posted: January 21, 2022
• Last Update Posted: June 9, 2023
• Sponsor: SWOG Cancer Research Network
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): SWOG Cancer Research Network

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Recurrent Squamous Cell Lung Carcinoma; Stage IV Squamous Cell Lung Carcinoma AJCC v7
• Interventions: Biological: Durvalumab; Other: Laboratory Biomarker Analysis; Biological: Tremelimumab
• Enrollment: 67

Participant Flow

Recruitment Details

Pre-assignment Details

67 patients were initially enrolled. 7 patients were ineligible for study; 6 did not receive anti-PD-L1 monotherapy as their most recent line of treatment and 1 had inadequate documentation of measurable disease. Another 2 patients were ineligible for analysis, as 1 expired prior to receiving any treatment and 1 withdrew consent prior to treatment. In all, 58 eligible patients received protocol therapy, 28 in the primary resistance cohort and 30 in the acquired resistance cohort.

Arm/Group Title	Treatment (Tremelimumab, Durvalumab)
Arm/Group Description	Patients receive tremelimumab IV over 60 minutes on day 1 for courses 1-4 and durvalumab IV over 60 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies Tremelimumab: Given IV
Period Title: Overall Study
Started	58
Completed	0
Not Completed	58
Reason Not Completed
Adverse Event	8
Disease Progression	46
Death	4

Baseline Characteristics

Arm/Group Title		Primary PD-(L)1 Resistance Cohort	Acquired PD-(L)1 Resistance Cohort	Total
Arm/Group Description		Prior response to immune checkpoint inhibitor monotherapy included disease progression within 24 weeks of initiation of single agent anti-PD-1/PD-L1 therapy.	Prior response to immune checkpoint inhibitor monotherapy included 24 weeks or more of disease control (complete response, partial response, or stable disease) after initiation of single agent anti-PD-1/PD-L1 therapy that had subsequently progressed after 24 weeks.	Total of all reporting groups
Overall Number of Baseline Participants		28	30	58
Baseline Analysis Population Description		Eligible and evaluable participants
Age, Continuous; Median (Full Range); Unit of measure: Years
	Number Analyzed	28 participants	30 participants	58 participants
		67.6; (49.7 to 89.8)	67.8; (46.6 to 84.0)	67.7; (46.6 to 89.8)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	28 participants	30 participants	58 participants
	Female	10 35.7%	12 40.0%	22 37.9%
	Male	18 64.3%	18 60.0%	36 62.1%
Race/Ethnicity, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	28 participants	30 participants	58 participants
Race : White		24	26	50
Race : Black		3	3	6
Race : Native American		1	0	1
Race : Not reported		0	1	1
Hispanic ethnicity		1	3	4
Number of prior lines of therapy for stage IV disease; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	28 participants	30 participants	58 participants
	<2	9 32.1%	12 40.0%	21 36.2%
	≥2 (max 4)	19 67.9%	18 60.0%	37 63.8%
Progression-free survival on prior anti-PD- ( L)1 therapy; Median (Full Range); Unit of measure: Months
	Number Analyzed	28 participants	30 participants	58 participants
		3.0; (1.4 to 5.5)	10.0; (5.6 to 30.4)	5.5; (1.4 to 30.4)
Best response to prior anti-PD- ( L)1 therapy; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	28 participants	30 participants	58 participants
	Complete response	0 0.0%	3 10.0%	3 5.2%
	Partial response	2 7.1%	7 23.3%	9 15.5%
	Stable disease	11 39.3%	20 66.7%	31 53.4%
	Progressive disease	15 53.6%	0 0.0%	15 25.9%
Performance status [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	28 participants	30 participants	58 participants
	0	7 25.0%	10 33.3%	17 29.3%
	1	21 75.0%	20 66.7%	41 70.7%
		[1] Measure Description: Participants were graded according to the Zubrod Performance Status Scale. 0 - Fully active, able to carry out on all pre-disease performance without restriction. 1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light housework, office work.
Smoking status; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	28 participants	30 participants	58 participants
	Current smoker	10 35.7%	10 33.3%	20 34.5%
	Former smoker	17 60.7%	19 63.3%	36 62.1%
	Never smoker	1 3.6%	1 3.3%	2 3.4%
Weight loss ≥10% in the 6 months prior to baseline; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	28 participants	30 participants	58 participants
		2 7.1%	2 6.7%	4 6.9%
PD-L1 expression (TPS (%)) [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	28 participants	30 participants	58 participants
	<1%	10 35.7%	3 10.0%	13 22.4%
	1%-49%	5 17.9%	9 30.0%	14 24.1%
	50%	5 17.9%	2 6.7%	7 12.1%
	Unknown	8 28.6%	16 53.3%	24 41.4%
		[1] Measure Description: PD-L1 expression was assessed by immunohistochemistry on tumor samples using 22C3 pharmDx assay (Agilent Technologies, Santa Clara, California, USA). PD-L1: programmed death ligand 1, TPS: Tumor Proportion Score.
Tumor mutational burden; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	28 participants	30 participants	58 participants
	<10 mt/Mb	8 28.6%	11 36.7%	19 32.8%
	≥10 mt/Mb	17 60.7%	17 56.7%	34 58.6%
	Not evaluable	3 10.7%	2 6.7%	5 8.6%

Outcome Measures

1. Primary Outcome

Title	Objective Response Rate
Description	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.
Time Frame	From date of registration to progression or treatment discontinuation, up to 2 years and 5.5 months.

Outcome Measure Data

Analysis Population Description

Eligible and evaluable participants

Arm/Group Title	Primary PD-(L)1 Resistance Cohort	Acquired PD-(L)1 Resistance Cohort
Arm/Group Description:	Prior response to immune checkpoint inhibitor monotherapy included disease progression within 24 weeks of initiation of single agent anti-PD-1/PD-L1 therapy.	Prior response to immune checkpoint inhibitor monotherapy included 24 weeks or more of disease control (complete response, partial response, or stable disease) after initiation of single agent anti-PD-1/PD-L1 therapy that had subsequently progressed after 24 weeks.
Overall Number of Participants Analyzed	28	30
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	7; (0 to 17)	0 [1]; (NA to NA)

[1]

There were 0 responses in the acquired resistance cohort so 95% confidence interval is not applicable here.

2. Secondary Outcome

Title	Duration of Response (DoR) Among Patients Who Achieve a Complete Response (CR) or Partial Response (PR) (Confirmed and Unconfirmed) by RECIST 1.1.
Description	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
Time Frame	From date of registration to maximum of 2 years and 5.5 months or death.

Outcome Measure Data

Analysis Population Description

Eligible and evaluable participants.

Arm/Group Title	Treatment (Tremelimumab, Durvalumab)
Arm/Group Description:	Patients receive tremelimumab IV over 60 minutes on day 1 for courses 1-4 and durvalumab IV over 60 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies Tremelimumab: Given IV
Overall Number of Participants Analyzed	2
Measure Type: Number; Unit of Measure: months
Duration of response for the first responding patient in the primary resistance cohort	8.5
Duration of response for the second responding patient in the primary resistance cohort	5.9

3. Secondary Outcome

Title	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
Description	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.
Time Frame	From date of registration to maximum of 2 years and 5.5 months or death

Outcome Measure Data

Analysis Population Description

Data were not collected for this outcome.

Arm/Group Title	Treatment (Tremelimumab, Durvalumab)
Arm/Group Description:	Patients receive tremelimumab IV over 60 minutes on day 1 for courses 1-4 and durvalumab IV over 60 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies Tremelimumab: Given IV
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

4. Secondary Outcome

Title	Overall Survival (OS) Among Patients Treated With MEDI4736 (Durvalumab) Plus Tremelimumab
Description	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.
Time Frame	Date of registration to maximum of 2 years and 5.5 months or death.

Outcome Measure Data

Analysis Population Description

Eligible and evaluable participants

Arm/Group Title	Primary PD-(L)1 Resistance Cohort	Acquired PD-(L)1 Resistance Cohort
Arm/Group Description:	Prior response to immune checkpoint inhibitor monotherapy included disease progression within 24 weeks of initiation of single agent anti-PD-1/PD-L1 therapy.	Prior response to immune checkpoint inhibitor monotherapy included 24 weeks or more of disease control (complete response, partial response, or stable disease) after initiation of single agent anti-PD-1/PD-L1 therapy that had subsequently progressed after 24 weeks.
Overall Number of Participants Analyzed	28	30
Median (95% Confidence Interval); Unit of Measure: months
	7.7; (4.0 to 12.0)	7.6; (5.3 to 10.2)

5. Secondary Outcome

Title	Investigator-assessed Progression-free Survival (IA-PFS) Among Patients Treated With MEDI4736 (Durvalumab) Plus Tremelimumab.
Description	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.
Time Frame	From date of registration to maximum 2 years and 5.5 months or death.

Outcome Measure Data

Analysis Population Description

Eligible and evaluable participants

Arm/Group Title	Primary PD-(L)1 Resistance Cohort	Acquired PD-(L)1 Resistance Cohort
Arm/Group Description:	Prior response to immune checkpoint inhibitor monotherapy included disease progression within 24 weeks of initiation of single agent anti-PD-1/PD-L1 therapy.	Prior response to immune checkpoint inhibitor monotherapy included 24 weeks or more of disease control (complete response, partial response, or stable disease) after initiation of single agent anti-PD-1/PD-L1 therapy that had subsequently progressed after 24 weeks.
Overall Number of Participants Analyzed	28	30
Median (95% Confidence Interval); Unit of Measure: months
	2.0; (1.6 to 3.0)	2.1; (1.6 to 3.2)

6. Secondary Outcome

Title	Investigator-assessed Progression-free Survival (IA-PFS) Assessed by Immune-related Response Criteria (irRC-IA-PFS) Among Patients Treated With MEDI4736 (Durvalumab) Plus Tremelimumab
Description	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.
Time Frame	Date of registration to maximum of 2 years and 5.5 months or death

Outcome Measure Data

Analysis Population Description

Data were not collected for this outcome.

Arm/Group Title	Treatment (Tremelimumab, Durvalumab)
Arm/Group Description:	Patients receive tremelimumab IV over 60 minutes on day 1 for courses 1-4 and durvalumab IV over 60 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Durvalumab: Given IV Laboratory Biomarker Analysis: Correlative studies Tremelimumab: Given IV
Overall Number of Participants Analyzed	0

No data displayed because Outcome Measure has zero total analyzed.

7. Secondary Outcome

Title	Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
Description	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).
Time Frame	Duration of treatment and follow up until death or 2 years and 5.5 months post registration

Outcome Measure Data

Analysis Population Description

Participants who received at least one dose of protocol treatment

Arm/Group Title	MEDI4736 + Tremelimumab
Arm/Group Description:	Participants receive tremelimumab and durvalumab on day 1 of each 28-day cycle for four cycles. Starting at cycle 5, participants receive durvalumab on day 1 of each cycle until disease progression or unacceptable toxicity. Tremelimumab: Given IV Durvalumab: Given IV
Overall Number of Participants Analyzed	58
Measure Type: Number; Unit of Measure: Participants
Atrial fibrillation	1
Atrial flutter	1
Chills	1
Confusion	1
Creatinine increased	1
Death NOS	1
Dehydration	3
Diarrhea	4
Dyspnea	5
Encephalopathy	1
Fatigue	1
Febrile neutropenia	1
Generalized muscle weakness	1
Hyperglycemia	1
Hypoxia	2
Lung infection	1
Lymphocyte count decreased	3
Nausea	1
Neutrophil count decreased	1
Platelet count decreased	3
Pneumonitis	2
Rash maculo-papular	1
Vomiting	1
White blood cell decreased	1

Adverse Events

Time Frame	Duration of treatment and follow-up until death or 3 years post registration
Adverse Event Reporting Description	CTCAE Version 4.0 was used for routine toxicity reporting and CTCAE Version 5.0 was used for Serious Adverse Event (SAE) reporting. 58 participants were assessed for AEs: 28 in the primary PD-L1 resistance cohort and 30 in the acquired PD-L1 resistance cohort.
Arm/Group Title	MEDI4736 + Tremelimumab
Arm/Group Description	Participants receive tremelimumab and durvalumab on day 1 of each 28-day cycle for four cycles. Starting at cycle 5, participants receive durvalumab on day 1 of each cycle until disease progression or unacceptable toxicity. Tremelimumab: Given IV Durvalumab: Given IV
All-Cause Mortality
	MEDI4736 + Tremelimumab
	Affected / at Risk (%)
Total	47/58 (81.03%)
Serious Adverse Events
	MEDI4736 + Tremelimumab
	Affected / at Risk (%)
Total	36/58 (62.07%)
Blood and lymphatic system disorders
Anemia †	2/58 (3.45%)
Febrile neutropenia †	1/58 (1.72%)
Cardiac disorders
Atrial fibrillation †	1/58 (1.72%)
Atrial flutter †	1/58 (1.72%)
Cardiac arrest †	1/58 (1.72%)
Heart failure †	1/58 (1.72%)
Gastrointestinal disorders
Colitis †	2/58 (3.45%)
Diarrhea †	9/58 (15.52%)
Esophageal obstruction †	1/58 (1.72%)
Esophagitis †	1/58 (1.72%)
Nausea †	2/58 (3.45%)
Vomiting †	3/58 (5.17%)
General disorders
Chills †	1/58 (1.72%)
Death NOS †	3/58 (5.17%)
Fatigue †	1/58 (1.72%)
Infections and infestations
Lung infection †	4/58 (6.90%)
Skin infection †	1/58 (1.72%)
Injury, poisoning and procedural complications
Fall †	1/58 (1.72%)
Hip fracture †	1/58 (1.72%)
Investigations
Alanine aminotransferase increased †	2/58 (3.45%)
Aspartate aminotransferase increased †	2/58 (3.45%)
Blood bilirubin increased †	1/58 (1.72%)
Creatinine increased †	3/58 (5.17%)
Electrocardiogram QT corrected interval prolonged †	1/58 (1.72%)
Fibrinogen decreased †	1/58 (1.72%)
Lymphocyte count decreased †	2/58 (3.45%)
Neutrophil count decreased †	1/58 (1.72%)
Platelet count decreased †	2/58 (3.45%)
Serum amylase increased †	1/58 (1.72%)
White blood cell decreased †	1/58 (1.72%)
Metabolism and nutrition disorders
Anorexia †	3/58 (5.17%)
Dehydration †	3/58 (5.17%)
Hypokalemia †	2/58 (3.45%)
Hyponatremia †	1/58 (1.72%)
Musculoskeletal and connective tissue disorders
Generalized muscle weakness †	1/58 (1.72%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified - Other †	5/58 (8.62%)
Nervous system disorders
Dizziness †	2/58 (3.45%)
Encephalopathy †	1/58 (1.72%)
Peripheral sensory neuropathy †	2/58 (3.45%)
Syncope †	1/58 (1.72%)
Psychiatric disorders
Confusion †	1/58 (1.72%)
Renal and urinary disorders
Hematuria †	1/58 (1.72%)
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage †	1/58 (1.72%)
Cough †	1/58 (1.72%)
Dyspnea †	7/58 (12.07%)
Hypoxia †	3/58 (5.17%)
Pleural effusion †	2/58 (3.45%)
Pneumonitis †	3/58 (5.17%)
Pneumothorax †	1/58 (1.72%)
Resp, thoracic and mediastinal disorders - Other †	1/58 (1.72%)
Respiratory failure †	2/58 (3.45%)
Skin and subcutaneous tissue disorders
Bullous dermatitis †	1/58 (1.72%)
Rash maculo-papular †	2/58 (3.45%)
Skin and subcutaneous tissue disorders - Other †	1/58 (1.72%)
Vascular disorders
Hematoma †	1/58 (1.72%)
Thromboembolic event †	1/58 (1.72%)
† Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	MEDI4736 + Tremelimumab
	Affected / at Risk (%)
Total	58/58 (100.00%)
Blood and lymphatic system disorders
Anemia †	24/58 (41.38%)
Cardiac disorders
Atrial fibrillation †	3/58 (5.17%)
Endocrine disorders
Endocrine disorders-Other †	3/58 (5.17%)
Hypothyroidism †	5/58 (8.62%)
Gastrointestinal disorders
Abdominal pain †	5/58 (8.62%)
Constipation †	7/58 (12.07%)
Diarrhea †	12/58 (20.69%)
Dysphagia †	5/58 (8.62%)
Nausea †	16/58 (27.59%)
Vomiting †	10/58 (17.24%)
General disorders
Chills †	6/58 (10.34%)
Edema limbs †	4/58 (6.90%)
Fatigue †	24/58 (41.38%)
Fever †	5/58 (8.62%)
Non-cardiac chest pain †	4/58 (6.90%)
Pain †	7/58 (12.07%)
Infections and infestations
Bronchial infection †	3/58 (5.17%)
Infections and infestations-Other †	3/58 (5.17%)
Lung infection †	3/58 (5.17%)
Urinary tract infection †	4/58 (6.90%)
Investigations
Alanine aminotransferase increased †	5/58 (8.62%)
Alkaline phosphatase increased †	9/58 (15.52%)
Aspartate aminotransferase increased †	6/58 (10.34%)
Creatinine increased †	7/58 (12.07%)
Investigations-Other †	6/58 (10.34%)
Lymphocyte count decreased †	15/58 (25.86%)
Platelet count decreased †	4/58 (6.90%)
Weight loss †	13/58 (22.41%)
White blood cell decreased †	3/58 (5.17%)
Metabolism and nutrition disorders
Anorexia †	16/58 (27.59%)
Dehydration †	7/58 (12.07%)
Hypercalcemia †	8/58 (13.79%)
Hyperglycemia †	12/58 (20.69%)
Hyperkalemia †	4/58 (6.90%)
Hypernatremia †	4/58 (6.90%)
Hypoalbuminemia †	20/58 (34.48%)
Hypocalcemia †	4/58 (6.90%)
Hypokalemia †	12/58 (20.69%)
Hypomagnesemia †	7/58 (12.07%)
Hyponatremia †	18/58 (31.03%)
Hypophosphatemia †	3/58 (5.17%)
Musculoskeletal and connective tissue disorders
Arthralgia †	3/58 (5.17%)
Back pain †	4/58 (6.90%)
Bone pain †	4/58 (6.90%)
Generalized muscle weakness †	7/58 (12.07%)
Myalgia †	4/58 (6.90%)
Pain in extremity †	5/58 (8.62%)
Nervous system disorders
Dizziness †	3/58 (5.17%)
Dysgeusia †	4/58 (6.90%)
Headache †	4/58 (6.90%)
Peripheral sensory neuropathy †	4/58 (6.90%)
Psychiatric disorders
Anxiety †	3/58 (5.17%)
Depression †	3/58 (5.17%)
Insomnia †	4/58 (6.90%)
Renal and urinary disorders
Urinary incontinence †	3/58 (5.17%)
Respiratory, thoracic and mediastinal disorders
Cough †	14/58 (24.14%)
Dyspnea †	25/58 (43.10%)
Hoarseness †	3/58 (5.17%)
Hypoxia †	3/58 (5.17%)
Productive cough †	4/58 (6.90%)
Resp, thoracic and mediastinal disorders - Other †	5/58 (8.62%)
Sore throat †	3/58 (5.17%)
Skin and subcutaneous tissue disorders
Dry skin †	3/58 (5.17%)
Pruritus †	14/58 (24.14%)
Rash maculo-papular †	5/58 (8.62%)
Vascular disorders
Hypertension †	5/58 (8.62%)
Hypotension †	4/58 (6.90%)
† Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Lung Committee Statistician
• Organization: SWOG Statistics and Data Management Center
• Phone: 2066674623
• EMail: kmini@fredhutch.org

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Leighl NB, Redman MW, Rizvi N, Hirsch FR, Mack PC, Schwartz LH, Wade JL, Irvin WJ, Reddy SC, Crawford J, Bradley JD, Stinchcombe TE, Ramalingam SS, Miao J, Minichiello K, Herbst RS, Papadimitrakopoulou VA, Kelly K, Gandara DR. Phase II study of durvalumab plus tremelimumab as therapy for patients with previously treated anti-PD-1/PD-L1 resistant stage IV squamous cell lung cancer (Lung-MAP substudy S1400F, NCT03373760). J Immunother Cancer. 2021 Aug;9(8):e002973. doi: 10.1136/jitc-2021-002973.

• Responsible Party: SWOG Cancer Research Network
• ClinicalTrials.gov Identifier: NCT03373760
• Other Study ID Numbers: S1400F; NCI-2016-01597 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ); S1400F; S1400F ( Other Identifier: SWOG ); S1400F ( Other Identifier: CTEP ); U10CA180888 ( U.S. NIH Grant/Contract )
• First Submitted: December 11, 2017
• First Posted: December 14, 2017
• Results First Submitted: November 8, 2021
• Results First Posted: January 21, 2022
• Last Update Posted: June 9, 2023