ClinicalTrials.gg
CompletedNCT03373760Updated Jun 9, 2023Results posted

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

A Phase 2 interventional study of Durvalumab and Laboratory Biomarker Analysis in Recurrent Squamous Cell Lung Carcinoma and Stage IV Squamous Cell Lung Carcinoma AJCC v7, sponsored by SWOG Cancer Research Network. Completed at 1,021 sites in United States. Per ClinicalTrials.gov, last updated 2023-06-09.

Sponsored by SWOG Cancer Research Network · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
67
Allocation
Not applicable
Sex
All
01

Study summary

This phase II trial studies how well durvalumab and tremelimumab works in treating patients with stage IV lung cancer that has come back after previous treatment. Monoclonal antibodies, such as durvalumab and tremelimumab, may interfere with the ability of tumor cells to grow and spread.

Read the detailed description

PRIMARY OBJECTIVES:

I. To evaluate the objective response rate (confirmed and unconfirmed, complete and partial) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 among patients treated with durvalumab (MEDI4736) plus tremelimumab.

SECONDARY OBJECTIVES:

I. To estimate the duration of response (DoR) among patients who achieve a complete response (CR) or partial response (PR) (confirmed and unconfirmed) by RECIST 1.1.

II. To estimate the 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.

III. To evaluate overall survival (OS) among patients treated with durvalumab (MEDI4736) plus tremelimumab.

IV. To evaluate investigator-assessed progression-free survival (IA-PFS) among patients treated with durvalumab (MEDI4736) plus tremelimumab.

V. To evaluate IA-PFS assessed by immune-related response criteria (irRC-IA-PFS) among patients treated with durvalumab (MEDI4736) plus tremelimumab.

VI. To evaluate the frequency and severity of toxicities associated with durvalumab (MEDI4736) plus tremelimumab.

TERTIARY OBJECTIVES:

I. To explore the association of potential predictive markers identified in S1400A, with response and progression-free survival (PFS).

II. To explore the association of PD-L1 expression status with response and PFS.

III. To contribute to an ongoing serum and tumor bank in S1400.

OUTLINE:

Patients receive tremelimumab intravenously (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.

After completion of study treatment, patients are followed up every 6 months for 2 years, and then at the end of year 3.

02

Conditions studied

  • Recurrent Squamous Cell Lung Carcinoma
  • Stage IV Squamous Cell Lung Carcinoma AJCC v7
03

In context

Lead sponsor

SWOG Cancer Research Network is the lead sponsor of 339 studies on the registry; 37 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria:

  • Patients must have been assigned to S1400F
  • Patients must have progressed during or after prior platinum-based chemotherapy; patients whose only prior platinum-based chemotherapy regimen was for stage I-III disease (i.e. patient has not received any platinum-based chemotherapy for stage IV or recurrent disease), disease progression on platinum-based chemotherapy must have occurred within one year from the last date that patient received that therapy; patients must have experienced disease progression during or after prior or anti-PD-L1 antibody monotherapy as their most recent ; prior PD-1/PD-L1 combination therapy is not permitted
  • Prior exposure to CTLA-4 inhibitors (ipilimumab and tremelimumab) is not permitted; prior exposure to the following is allowed: attenuated vaccines, anti-EGFR agents, and granulocyte-macrophage colony-stimulating factor (GM-CSF)
  • Patients must not have received nitrosoureas or mitomycin-C within 42 days prior to sub-study registration
  • Patients must not have any prior documented or inflammatory disease (including inflammatory bowel disease, diverticulitis with the exception of diverticulosis, celiac disease, irritable bowel disease; Wegner syndrome; Hashimoto syndrome) within 3 years prior to sub-study registration; patients with vitiligo, immune-mediated alopecia, Grave?s disease, or psoriasis requiring systemic treatment within the past 2 years are not eligible; patients with hypothyroidism (e.g. post Hashimoto syndrome) who are stable on hormone replacement therapy are eligible
  • Patients must not have any history of primary immunodeficiency
  • Patients must not have received any medication within 28 days prior to sub-study registration and must not be planning to receive these medications while on protocol therapy; systemic must be stopped at least 24 hours prior to sub-study registration; however, intranasal and inhaled corticosteroids are allowed at any time before and during protocol therapy
  • Patients must not have experienced a grade 3 or worse immune-related adverse event (irAE) (except asymptomatic nonbullous/nonexfoliative rash) or any unresolved irAE grade 2, nor have experienced a toxicity that led to permanent discontinuation of prior anti-PD-1/PD-L1 immunotherapy
  • Patients must not have any history of organ transplant that requires use of immunosuppressives
  • Patients must not have any known allergy or reaction to any component of the durvalumab (MEDI4736) and/or tremelimumab formulation
  • Patients must not have clinical signs or symptoms of active tuberculosis infection
  • Patients must not have received a within 28 days prior to sub-study registration
  • Patients must not have known (HIV), or a known positive test for virus surface antigen (HBV sAg), or virus ribonucleic acid (HCV antibody) indicating current acute or chronic infection; patients with a positive hepatitis C antibody with a negative viral load are allowed
  • Patients must have a thyroid-stimulating hormone (TSH) with reflex free T3/free T4 (if TSH is out of normal range) and (EKG) obtained within 7 days prior to sub-study registration
  • Patients must also be offered participation in banking and in the correlative studies for collection and future use of specimens
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

PD-1, PD-L1 and checkpoint inhibitors

PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.

PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
67 participants (actual)

Study arms

  • Experimental
    Treatment (tremelimumab, durvalumab)

    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.

    Biological: Durvalumab · Other: Laboratory Biomarker Analysis · Biological: Tremelimumab

Interventions

  • BiologicalDurvalumab

    Given IV

    Also known as: Imfinzi, Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI-4736, MEDI4736

  • OtherLaboratory Biomarker Analysis

    Correlative studies

  • BiologicalTremelimumab

    Given IV

    Also known as: Anti-CTLA4 Human Monoclonal Antibody CP-675,206, CP-675, CP-675,206, CP-675206, ticilimumab

06

What researchers measure

Primary outcomes

  1. Objective Response Rate

    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.

Secondary outcomes

  1. Duration of Response (DoR) Among Patients Who Achieve a Complete Response (CR) or Partial Response (PR) (Confirmed and Unconfirmed) by RECIST 1.1.

    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.

  2. 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

    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

  3. Overall Survival (OS) Among Patients Treated With MEDI4736 (Durvalumab) Plus Tremelimumab

    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.

  4. Investigator-assessed Progression-free Survival (IA-PFS) Among Patients Treated With MEDI4736 (Durvalumab) Plus Tremelimumab.

    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.

  5. Investigator-assessed Progression-free Survival (IA-PFS) Assessed by Immune-related Response Criteria (irRC-IA-PFS) Among Patients Treated With MEDI4736 (Durvalumab) Plus Tremelimumab

    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

  6. Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

    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

07

Results

Posted Jan 21, 2022

Participant flow

Participant flow — Overall Study
MilestoneTreatment (Tremelimumab, Durvalumab)
Started58
Completed0
Not completed58
Withdrew: Adverse event8
Withdrew: Disease progression46
Withdrew: Death4

Outcome measures

PrimaryObjective Response Rate

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.
Reported as:
Number · percentage of participants
Objective Response Rate
percentage of participantsPrimary PD-(L)1 Resistance CohortAcquired PD-(L)1 Resistance Cohort
Objective Response Rate7 (0 to 17)0 (NA to NA)
SecondaryDuration of Response (DoR) Among Patients Who Achieve a Complete Response (CR) or Partial Response (PR) (Confirmed and Unconfirmed) by RECIST 1.1.

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.
Reported as:
Number · months
Duration of Response (DoR) Among Patients Who Achieve a Complete Response (CR) or Partial Response (PR) (Confirmed and Unconfirmed) by RECIST 1.1.
monthsTreatment (Tremelimumab, Durvalumab)
Duration of response for the first responding patient in the primary resistance cohort8.5
Duration of response for the second responding patient in the primary resistance cohort5.9
SecondaryDuration 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

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

No measurements were reported for this outcome.

SecondaryOverall Survival (OS) Among Patients Treated With MEDI4736 (Durvalumab) Plus Tremelimumab

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.
Reported as:
Median · months
Overall Survival (OS) Among Patients Treated With MEDI4736 (Durvalumab) Plus Tremelimumab
monthsPrimary PD-(L)1 Resistance CohortAcquired PD-(L)1 Resistance Cohort
Overall Survival (OS) Among Patients Treated With MEDI4736 (Durvalumab) Plus Tremelimumab7.7 (4.0 to 12.0)7.6 (5.3 to 10.2)
SecondaryInvestigator-assessed Progression-free Survival (IA-PFS) Among Patients Treated With MEDI4736 (Durvalumab) Plus Tremelimumab.

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.
Reported as:
Median · months
Investigator-assessed Progression-free Survival (IA-PFS) Among Patients Treated With MEDI4736 (Durvalumab) Plus Tremelimumab.
monthsPrimary PD-(L)1 Resistance CohortAcquired PD-(L)1 Resistance Cohort
Investigator-assessed Progression-free Survival (IA-PFS) Among Patients Treated With MEDI4736 (Durvalumab) Plus Tremelimumab.2.0 (1.6 to 3.0)2.1 (1.6 to 3.2)
SecondaryInvestigator-assessed Progression-free Survival (IA-PFS) Assessed by Immune-related Response Criteria (irRC-IA-PFS) Among Patients Treated With MEDI4736 (Durvalumab) Plus Tremelimumab

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

No measurements were reported for this outcome.

SecondaryNumber of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs

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
Reported as:
Number · Participants
Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs
ParticipantsMEDI4736 + Tremelimumab
Atrial fibrillation1
Atrial flutter1
Chills1
Confusion1
Creatinine increased1
Death NOS1
Dehydration3
Diarrhea4
Dyspnea5
Encephalopathy1
Fatigue1
Febrile neutropenia1
Generalized muscle weakness1
Hyperglycemia1
Hypoxia2
Lung infection1
Lymphocyte count decreased3
Nausea1
Neutrophil count decreased1
Platelet count decreased3
Pneumonitis2
Rash maculo-papular1
Vomiting1
White blood cell decreased1

Adverse events

Collected over Duration of treatment and follow-up until death or 3 years post registration. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
MEDI4736 + Tremelimumab47/58 (81%)36/58 (62.1%)58/58 (100%)
Most frequent serious events
Showing 10 of 56
Most frequent serious events
EventMEDI4736 + Tremelimumab
DiarrheaGastrointestinal disorders9/58
DyspneaRespiratory, thoracic and mediastinal disorders7/58
Neoplasms benign, malignant and unspecified - OtherNeoplasms benign, malignant and unspecified (incl cysts and polyps)5/58
Lung infectionInfections and infestations4/58
VomitingGastrointestinal disorders3/58
Death NOSGeneral disorders3/58
Creatinine increasedInvestigations3/58
AnorexiaMetabolism and nutrition disorders3/58
DehydrationMetabolism and nutrition disorders3/58
HypoxiaRespiratory, thoracic and mediastinal disorders3/58
Most frequent other events
Showing 10 of 67
Most frequent other events
EventMEDI4736 + Tremelimumab
DyspneaRespiratory, thoracic and mediastinal disorders25/58
AnemiaBlood and lymphatic system disorders24/58
FatigueGeneral disorders24/58
HypoalbuminemiaMetabolism and nutrition disorders20/58
HyponatremiaMetabolism and nutrition disorders18/58
NauseaGastrointestinal disorders16/58
AnorexiaMetabolism and nutrition disorders16/58
Lymphocyte count decreasedInvestigations15/58
CoughRespiratory, thoracic and mediastinal disorders14/58
PruritusSkin and subcutaneous tissue disorders14/58

Baseline characteristics

Eligible and evaluable participants

Age, Continuous
Age, Continuous(years)Primary PD-(L)1 Resistance CohortAcquired PD-(L)1 Resistance CohortTotal
Median67.6 (49.7 to 89.8)67.8 (46.6 to 84.0)67.7 (46.6 to 89.8)
Sex: Female, Male
Sex: Female, Male(Participants)Primary PD-(L)1 Resistance CohortAcquired PD-(L)1 Resistance CohortTotal
Female101222
Male181836
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Primary PD-(L)1 Resistance CohortAcquired PD-(L)1 Resistance CohortTotal
Race : White242650
Race : Black336
Race : Native American101
Race : Not reported011
Hispanic ethnicity134
Number of prior lines of therapy for stage IV disease
Number of prior lines of therapy for stage IV disease(Participants)Primary PD-(L)1 Resistance CohortAcquired PD-(L)1 Resistance CohortTotal
<291221
≥2 (max 4)191837
Progression-free survival on prior anti-PD- ( L)1 therapy
Progression-free survival on prior anti-PD- ( L)1 therapy(months)Primary PD-(L)1 Resistance CohortAcquired PD-(L)1 Resistance CohortTotal
Median3.0 (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
Best response to prior anti-PD- ( L)1 therapy(Participants)Primary PD-(L)1 Resistance CohortAcquired PD-(L)1 Resistance CohortTotal
Complete response033
Partial response279
Stable disease112031
Progressive disease15015
Performance status
Performance status(Participants)Primary PD-(L)1 Resistance CohortAcquired PD-(L)1 Resistance CohortTotal
071017
1212041
Smoking status
Smoking status(Participants)Primary PD-(L)1 Resistance CohortAcquired PD-(L)1 Resistance CohortTotal
Current smoker101020
Former smoker171936
Never smoker112

3 further baseline measures are reported on the registry.

08

Study locations

1,021 sites
  • University of Alabama at Birmingham Cancer Center
    Birmingham, Alabama 35233, United States
  • Anchorage Associates in Radiation Medicine
    Anchorage, Alaska 98508, United States
  • Alaska Breast Care and Surgery LLC
    Anchorage, Alaska 99508, United States
  • Alaska Oncology and Hematology LLC
    Anchorage, Alaska 99508, United States
  • Alaska Women's Cancer Care
    Anchorage, Alaska 99508, United States
  • Anchorage Oncology Centre
    Anchorage, Alaska 99508, United States
  • Katmai Oncology Group
    Anchorage, Alaska 99508, United States
  • Providence Alaska Medical Center
    Anchorage, Alaska 99508, United States
  • Fairbanks Memorial Hospital
    Fairbanks, Alaska 99701, United States
  • University of Arizona Cancer Center-North Campus
    Tucson, Arizona 85719, United States
  • The University of Arizona Medical Center-University Campus
    Tucson, Arizona 85724, United States
  • Mercy Cancer Center-Hot Springs
    Hot Springs, Arkansas 71913, United States
  • Fowler Family Center for Cancer Care
    Jonesboro, Arkansas 72401, United States
  • Kaiser Permanente-Anaheim
    Anaheim, California 92807, United States
  • Kaiser Permanente-Deer Valley Medical Center
    Antioch, California 94531, United States
  • Sutter Auburn Faith Hospital
    Auburn, California 95602, United States
  • Sutter Cancer Centers Radiation Oncology Services-Auburn
    Auburn, California 95603, United States
  • AIS Cancer Center at San Joaquin Community Hospital
    Bakersfield, California 93301, United States
  • Kaiser Permanente-Baldwin Park
    Baldwin Park, California 91706, United States
  • Kaiser Permanente-Bellflower
    Bellflower, California 90706, United States
  • Alta Bates Summit Medical Center-Herrick Campus
    Berkeley, California 94704, United States
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
    Burbank, California 91505, United States
  • Mills-Peninsula Medical Center
    Burlingame, California 94010, United States
  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park
    Cameron Park, California 95682, United States
  • Eden Hospital Medical Center
    Castro Valley, California 94546, United States
  • City of Hope Corona
    Corona, California 92879, United States
  • Sutter Davis Hospital
    Davis, California 95616, United States
  • City of Hope Comprehensive Cancer Center
    Duarte, California 91010, United States
  • Kaiser Permanente Hospital
    Fontana, California 92335, United States
  • Kaiser Permanente-Fremont
    Fremont, California 94538, United States
  • Palo Alto Medical Foundation-Fremont
    Fremont, California 94538, United States
  • Kaiser Permanente
    Fresno, California 93720, United States
  • Saint Jude Medical Center
    Fullerton, California 92835, United States
  • Kaiser Permanente - Harbor City
    Harbor City, California 90710, United States
  • Kaiser Permanente-Irvine
    Irvine, California 92618, United States
  • UC San Diego Moores Cancer Center
    La Jolla, California 92093, United States
  • City of Hope Antelope Valley
    Lancaster, California 93534, United States
  • Kaiser Permanente Los Angeles Medical Center
    Los Angeles, California 90027, United States
  • Kaiser Permanente-Cadillac
    Los Angeles, California 90034, United States
  • Fremont - Rideout Cancer Center
    Marysville, California 95901, United States
  • City of Hope Mission Hills
    Mission Hills, California 91345, United States
  • Memorial Medical Center
    Modesto, California 95355, United States
  • Kaiser Permanente-Modesto
    Modesto, California 95356, United States
  • Palo Alto Medical Foundation-Camino Division
    Mountain View, California 94040, United States
  • Palo Alto Medical Foundation-Gynecologic Oncology
    Mountain View, California 94040, United States
  • Sutter Cancer Research Consortium
    Novato, California 94945, United States
  • Kaiser Permanente-Oakland
    Oakland, California 94611, United States
  • Saint Joseph Hospital - Orange
    Orange, California 92868, United States
  • Palo Alto Medical Foundation Health Care
    Palo Alto, California 94301, United States
  • Kaiser Permanente - Panorama City
    Panorama City, California 91402, United States
  • Feather River Cancer Center
    Paradise, California 95969, United States
  • PCR Oncology
    Pismo Beach, California 93449, United States
  • City of Hope Rancho Cucamonga
    Rancho Cucamonga, California 91730, United States
  • Eisenhower Medical Center
    Rancho Mirage, California 92270, United States
  • Kaiser Permanente-Redwood City
    Redwood City, California 94063, United States
  • Kaiser Permanente-Richmond
    Richmond, California 94801, United States
  • Kaiser Permanente-Riverside
    Riverside, California 92505, United States
  • Kaiser Permanente-Roseville
    Roseville, California 95661, United States
  • Sutter Cancer Centers Radiation Oncology Services-Roseville
    Roseville, California 95661, United States
  • Sutter Roseville Medical Center
    Roseville, California 95661, United States
  • Sutter Medical Center Sacramento
    Sacramento, California 95816, United States
  • University of California Davis Comprehensive Cancer Center
    Sacramento, California 95817, United States
  • Kaiser Permanente-South Sacramento
    Sacramento, California 95823, United States
  • Kaiser Permanente - Sacramento
    Sacramento, California 95825, United States
  • Saint Helena Hospital
    Saint Helena, California 94574, United States
  • Kaiser Permanente-San Diego Mission
    San Diego, California 92108, United States
  • Kaiser Permanente-San Diego Zion
    San Diego, California 92120, United States
  • California Pacific Medical Center-Pacific Campus
    San Francisco, California 94115, United States
  • Kaiser Permanente-San Francisco
    San Francisco, California 94115, United States
  • Kaiser Permanente-Santa Teresa-San Jose
    San Jose, California 95119, United States
  • Kaiser Permanente San Leandro
    San Leandro, California 94577, United States
  • Kaiser Permanente-San Marcos
    San Marcos, California 92069, United States
  • Kaiser Permanente-San Rafael
    San Rafael, California 94903, United States
  • Kaiser Permanente Medical Center - Santa Clara
    Santa Clara, California 95051, United States
  • Palo Alto Medical Foundation-Santa Cruz
    Santa Cruz, California 95065, United States
  • Kaiser Permanente-Santa Rosa
    Santa Rosa, California 95403, United States
  • Sutter Pacific Medical Foundation
    Santa Rosa, California 95403, United States
  • City of Hope South Pasadena
    South Pasadena, California 91030, United States
  • Kaiser Permanente-South San Francisco
    South San Francisco, California 94080, United States
  • Kaiser Permanente-Stockton
    Stockton, California 95210, United States
  • Palo Alto Medical Foundation-Sunnyvale
    Sunnyvale, California 94086, United States
  • Gene Upshaw Memorial Tahoe Forest Cancer Center
    Truckee, California 96161, United States
  • Sutter Cancer Centers Radiation Oncology Services-Vacaville
    Vacaville, California 95687, United States
  • Kaiser Permanente Medical Center-Vacaville
    Vacaville, California 95688, United States
  • Kaiser Permanente-Vallejo
    Vallejo, California 94589, United States
  • Sutter Solano Medical Center/Cancer Center
    Vallejo, California 94589, United States
  • Kaiser Permanente-Walnut Creek
    Walnut Creek, California 94596, United States
  • Presbyterian Intercommunity Hospital
    Whittier, California 90602, United States
  • Kaiser Permanente
    Woodland Hills, California 91367, United States
  • Rocky Mountain Cancer Centers-Aurora
    Aurora, Colorado 80012, United States
  • University of Colorado Hospital
    Aurora, Colorado 80045, United States
  • Boulder Community Hospital
    Boulder, Colorado 80301, United States
  • Rocky Mountain Cancer Centers-Boulder
    Boulder, Colorado 80304, United States
  • Penrose-Saint Francis Healthcare
    Colorado Springs, Colorado 80907, United States
  • Rocky Mountain Cancer Centers-Penrose
    Colorado Springs, Colorado 80907, United States
  • Memorial Hospital Central
    Colorado Springs, Colorado 80909, United States
  • Denver Health Medical Center
    Denver, Colorado 80204, United States
  • Kaiser Permanente-Franklin
    Denver, Colorado 80205, United States
  • National Jewish Health-Main Campus
    Denver, Colorado 80206, United States
  • The Women's Imaging Center
    Denver, Colorado 80209, United States

Showing the first 100 of 1,021 sites. Choose a country and city above to see the rest.

09

References and documents

Publications

  • 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. PubMed 34429332 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2017 to primary completion in May 2020, 29 months.

Results were first posted in Jan 2022, 1 year 8 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 11, 2017
First posted
Dec 14, 2017
StartActual
Nov 30, 2017
Primary completionActual
May 18, 2020
CompletionActual
Mar 29, 2022
Results first posted
Jan 21, 2022
Last update
Jun 9, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03373760
Responsible party
Sponsor
First posted
Dec 14, 2017
Start date
Nov 30, 2017
Primary completion
May 18, 2020
Completion
Mar 29, 2022
Results posted
Jan 21, 2022
Last update
Jun 9, 2023

Study contacts

Vassiliki Papadimitrakopoulou
principal investigator · SWOG Cancer Research Network

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Tremelimumab

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