- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03822351
Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC (COAST)
December 11, 2023 updated by: MedImmune LLC
A Phase 2 Open-label, Multicenter, Randomized, Multidrug Platform Study of Durvalumab (MEDI4736) Alone or in Combination With Novel Agents in Subjects With Locally Advanced, Unresectable (Stage III) Non-small Cell Lung Cancer (COAST)
The purpose of this study is to compare the clinical activity of durvalumab alone vs durvalumab in combination with novel agents.
The overall study goal is early identification of novel durvalumab combinations that are more active than durvalumab alone in the treatment of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Study D9108C00001 (COAST) is a Phase 2, open-label, multicenter, randomized multidrug platform study assessing the efficacy and safety of durvalumab alone vs durvalumab in combination with novel agents in subjects with locally advanced, unresectable, Stage III non-small cell lung cancer (NSCLC).
Study Type
Interventional
Enrollment (Actual)
188
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
- Research Site
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- Research Site
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Quebec
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Montreal, Quebec, Canada, H4A 3J1
- Research Site
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Bordeaux Cedex, France, 33076
- Research Site
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Brest, France, 29609
- Research Site
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Bron, France, 69677
- Research Site
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Creteil, France, 94010
- Research Site
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La Rochelle Cedex, France, 17019
- Research Site
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Lille, France, 59037
- Research Site
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Limoges Cedex, France, 87042
- Research Site
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Lyon Cedex 04, France, 69004
- Research Site
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Marseille Cedex 20, France, 13015
- Research Site
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Nice, France, 06189
- Research Site
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Pierre Benite, France, 69495
- Research Site
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Rennes Cedex 9, France, 35033
- Research Site
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STRASBOURG Cedex, France, 67065
- Research Site
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Toulouse, France, 31059
- Research Site
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Hong Kong, Hong Kong
- Research Site
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Jordan, Hong Kong
- Research Site
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Kowloon, Hong Kong
- Research Site
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Catania, Italy, 95125
- Research Site
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Cremona, Italy, 26100
- Research Site
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Milano, Italy, 20132
- Research Site
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Milano, Italy, 20133
- Research Site
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Palermo, Italy, 90127
- Research Site
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Ravenna, Italy, 48121
- Research Site
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Siena, Italy, 53100
- Research Site
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Gdynia, Poland, 81-519
- Research Site
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Lodz, Poland, 90-153
- Research Site
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Lodz, Poland, 90-242
- Research Site
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Lisboa, Portugal, 1500-650
- Research Site
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Lisboa, Portugal, 1400-038
- Research Site
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Porto, Portugal, 4099-001
- Research Site
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Porto, Portugal, 4200-072
- Research Site
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A Coruña, Spain, 15006
- Research Site
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Badajoz, Spain, 06008
- Research Site
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Barcelona, Spain, 08035
- Research Site
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Barcelona, Spain, 08041
- Research Site
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Barcelona, Spain, 08916
- Research Site
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Castelló de la Plana, Spain, 12002
- Research Site
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Madrid, Spain, 28034
- Research Site
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Málaga, Spain, 29010
- Research Site
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Valencia, Spain, 46014
- Research Site
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Chiayi, Taiwan, 61363
- Research Site
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Taichung, Taiwan, 402
- Research Site
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California
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Anaheim, California, United States, 92801
- Research Site
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Duarte, California, United States, 91010
- Research Site
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Sacramento, California, United States, 95825
- Research Site
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Connecticut
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New Haven, Connecticut, United States, 06510
- Research Site
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West Haven, Connecticut, United States, 06516
- Research Site
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District of Columbia
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Washington, District of Columbia, United States, 20007
- Research Site
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Florida
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Orlando, Florida, United States, 32804
- Research Site
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Winter Haven, Florida, United States, 33881
- Research Site
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Kansas
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Wichita, Kansas, United States, 67214
- Research Site
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Kentucky
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Lexington, Kentucky, United States, 40503
- Research Site
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Louisville, Kentucky, United States, 40202
- Research Site
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Louisiana
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Baton Rouge, Louisiana, United States, 70809
- Research Site
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Covington, Louisiana, United States, 70433
- Research Site
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Maryland
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Rosedale, Maryland, United States, 21237
- Research Site
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Nebraska
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Lincoln, Nebraska, United States, 68510
- Research Site
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New York
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New York, New York, United States, 10065
- Research Site
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New York, New York, United States, 10029
- Research Site
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Oregon
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Portland, Oregon, United States, 97227-1191
- Research Site
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Pennsylvania
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Gettysburg, Pennsylvania, United States, 17325
- Research Site
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Lancaster, Pennsylvania, United States, 17601
- Research Site
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Philadelphia, Pennsylvania, United States, 19104
- Research Site
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South Dakota
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Sioux Falls, South Dakota, United States, 57105
- Research Site
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Tennessee
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Germantown, Tennessee, United States, 38138
- Research Site
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Memphis, Tennessee, United States, 38120
- Research Site
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Texas
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Tyler, Texas, United States, 75701
- Research Site
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Utah
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Salt Lake City, Utah, United States, 84112
- Research Site
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Virginia
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Richmond, Virginia, United States, 23230
- Research Site
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Washington
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Tacoma, Washington, United States, 98405
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 99 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Main Inclusion Criteria:
- Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluation
- Age 18 years or older
- Body weight ≥ 35 kg
- Subjects must have histologically or cytologically documented NSCLC who present with locally advanced, unresectable, Stage III disease
- Subjects must have completed, without progressing, definitive cCRT within 42 days prior to being randomized into the study:
- Provision of tumor tissue sample, when available, from original diagnosis obtained before initiation of chemoradiotherapy
- Life expectancy ≥ 12 weeks
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Subjects must have at least one previously irradiated tumor lesion that can be measured by RECIST v1.1
Main Exclusion Criteria:
- Mixed small cell and non-small cell lung cancer histology
- Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug.
- Prior exposure to any anti-PD1, anti-PD-L1, or anti-CTLA4 antibody for treatment of NSCLC
- Subjects with history of ≥ Grade 2 pneumonitis from prior chemoradiation therapy
- Subjects with a history of venous thrombosis within the past 3 months
- Subjects with history of myocardial infarction, transient ischemic attack, or stroke in the past 6 months
- Congestive heart failure
- Active or prior documented autoimmune or inflammatory disorders
- History of active primary immunodeficiency
- Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
- History of allogenic organ transplantation
- QTcF interval ≥ 470 ms
- History of another primary malignancy
- Concurrent enrollment in another therapeutic clinical study or during the follow-up period of an interventional study. Enrollment in observational studies will be allowed
- Females who are pregnant, lactating, or intend to become pregnant during their participation in the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Control Arm (Durvalumab monotherapy)
durvalumab IV
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Durvalumab
Other Names:
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Experimental: Arm A (durvalumab + oleclumab):
durvalumab IV and oleclumab IV
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Durvalumab + Oleclumab
Other Names:
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Experimental: Arm B (durvalumab + monalizumab)
durvalumab IV and monalizumab IV
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Durvalumab + Monalizumab
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Objective Response (OR) rate as a measure of antitumor activity of durvalumab alone vs durvalumab in combination with novel agents
Time Frame: ORR at 16weeks after randomization is the timing for radiologic assessment of the primary endpoint
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Best overall response of confirmed CR or confirmed PR according to RECIST v1.1
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ORR at 16weeks after randomization is the timing for radiologic assessment of the primary endpoint
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Incidence of Adverse Events as a measure of safety during the treatment period
Time Frame: From time of informed consent through treatment period (12 months) or up to 3 months post last dose of study treatment
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The secondary endpoint of safety as assessed by the presence of adverse events and serious adverse events
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From time of informed consent through treatment period (12 months) or up to 3 months post last dose of study treatment
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Duration of Response (DoR) as a measure of efficacy of durvalumab alone vs durvalumab in combination with novel agents
Time Frame: From time of first documented response until disease progression or up to a maximum of 5 years after randomization
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The duration from the first documentation of a subsequently confirmed OR to the first documentation of a disease progression according to RECIST v1.1 or death due to any cause, whichever occurs first.
Only subjects who have achieved OR (confirmed CR or confirmed PR) will be evaluated for DoR
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From time of first documented response until disease progression or up to a maximum of 5 years after randomization
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Disease Control (DC) as a measure of efficacy of durvalumab alone vs durvalumab in combination with novel agents
Time Frame: From time of randomization until disease progression or up to a maximum of 5 years
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confirmed CR, confirmed PR, or SD based on RECIST v1.1
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From time of randomization until disease progression or up to a maximum of 5 years
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Progression-Free Survival (PFS) and Progression-Free Survival 12 month landmark rate (PFS-12) as a measure of efficacy of durvalumab alone vs durvalumab in combination with novel agents
Time Frame: From time of randomization until disease progression or up to a maximum of 5 years
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From randomization until the first documentation of disease progression according to RECIST v1.1 or death due to any cause, whichever occurs first
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From time of randomization until disease progression or up to a maximum of 5 years
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Serum durvalumab concentration levels
Time Frame: From randomization up to 15 months after first treatment
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Pharmacokinetics of durvalumab
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From randomization up to 15 months after first treatment
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Serum concentration levels of durvalumab or novel agents
Time Frame: From randomization up to 15 months after first treatment
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Pharmacokinetics of durvalumab alone and/or in combination with novel agents
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From randomization up to 15 months after first treatment
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Development of detectable anti-drug antibody (ADA) to durvalumab
Time Frame: From randomization up to 15 months after first treatment
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Immunogenicity of durvalumab
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From randomization up to 15 months after first treatment
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Development of detectable anti-drug antibody (ADA) to durvalumab or novel biologic agents
Time Frame: From randomization up to 15 months after first treatment
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Immunogenicity of durvalumab alone and/or in combination with novel biologic agents
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From randomization up to 15 months after first treatment
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Number of patients with clinically significant laboratory values as a measure of safety
Time Frame: From screening until disease progression or death, up to a maximum of 5 years after randomization
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Assess the presence of clinically significant laboratory values taken at times indicated in the assessment schedule from baseline in terms of number of patients with abnormal values
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From screening until disease progression or death, up to a maximum of 5 years after randomization
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Incidence of clinically significant vital sign values as a measure of safety
Time Frame: From screening until disease progression or death, up to a maximum of 5 years after randomization
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Assess the presence of clinically significant vital sign values from baseline
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From screening until disease progression or death, up to a maximum of 5 years after randomization
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 19, 2018
Primary Completion (Actual)
July 18, 2023
Study Completion (Actual)
July 18, 2023
Study Registration Dates
First Submitted
December 10, 2018
First Submitted That Met QC Criteria
January 29, 2019
First Posted (Actual)
January 30, 2019
Study Record Updates
Last Update Posted (Estimated)
December 12, 2023
Last Update Submitted That Met QC Criteria
December 11, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Antineoplastic Agents
- Immunologic Factors
- Antineoplastic Agents, Immunological
- Durvalumab
- Antibodies, Monoclonal
Other Study ID Numbers
- D9108C00001
- 2018-002931-35 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.
All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles.
For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool .
Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.
For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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