Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC
COAST
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)
2 other identifiers
interventional
189
9 countries
73
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2018
Typical duration for phase_2
73 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2018
CompletedStudy Start
First participant enrolled
December 19, 2018
CompletedFirst Posted
Study publicly available on registry
January 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 18, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 18, 2023
CompletedResults Posted
Study results publicly available
October 8, 2024
CompletedOctober 8, 2024
October 1, 2024
4.6 years
December 10, 2018
July 1, 2024
October 4, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Objective Response (OR) Rate as a Measure of Antitumor Activity of Durvalumab Alone vs Durvalumab in Combination With Novel Agents
ORR was defined as the percentage of participants with at least one visit response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1 for target lesions: CR: Disappearance of all target lesions; PR: \>=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.
ORR at 16 weeks after randomization is the timing for radiologic assessment of the primary endpoint
Secondary Outcomes (12)
Presence of Adverse Events as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
From time of signature of informed consent up to 15 months post the first dose of study treatment
Presence of Clinically Significant Laboratory Values as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
From baseline up to 15 months post the first dose of study treatment
Presence of Abnormalities in Vital Signs as a Measure of Safety and Tolerability of Durvalumab Alone and in Combination With Novel Agents
From baseline up to 15 months post the first dose of study treatment
Duration of Response (DoR) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents
Up to approximately 54 months (through the database cutoff date of 18-Jul-2023).
Disease Control (DC) as a Measure of Efficacy of Durvalumab Alone vs Durvalumab in Combination With Novel Agents
Up to approximately 54 months (through the database cutoff date of 18-Jul-2023).
- +7 more secondary outcomes
Study Arms (3)
Control Arm (Durvalumab monotherapy)
EXPERIMENTALdurvalumab IV
Arm A (durvalumab + oleclumab):
EXPERIMENTALdurvalumab IV and oleclumab IV
Arm B (durvalumab + monalizumab)
EXPERIMENTALdurvalumab IV and monalizumab IV
Interventions
Durvalumab + Oleclumab
Durvalumab + Monalizumab
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 clinical study \[concurrent enrollment in an observational (non-interventional) clinical study or during the follow-up period of an interventional study is permitted\]
- Females who are pregnant, lactating, or intend to become pregnant during their participation in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedImmune LLClead
Study Sites (73)
Research Site
Anaheim, California, 92801, United States
Research Site
Duarte, California, 91010, United States
Research Site
Sacramento, California, 95825, United States
Research Site
New Haven, Connecticut, 06510, United States
Research Site
West Haven, Connecticut, 06516, United States
Research Site
Washington D.C., District of Columbia, 20007, United States
Research Site
Orlando, Florida, 32804, United States
Research Site
Winter Haven, Florida, 33881, United States
Research Site
Wichita, Kansas, 67214, United States
Research Site
Lexington, Kentucky, 40503, United States
Research Site
Louisville, Kentucky, 40202, United States
Research Site
Baton Rouge, Louisiana, 70809, United States
Research Site
Covington, Louisiana, 70433, United States
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Rosedale, Maryland, 21237, United States
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Lincoln, Nebraska, 68510, United States
Research Site
New York, New York, 10029, United States
Research Site
New York, New York, 10065, United States
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Portland, Oregon, 97227-1191, United States
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Gettysburg, Pennsylvania, 17325, United States
Research Site
Lancaster, Pennsylvania, 17601, United States
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Philadelphia, Pennsylvania, 19104, United States
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Sioux Falls, South Dakota, 57105, United States
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Germantown, Tennessee, 38138, United States
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Memphis, Tennessee, 38120, United States
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Tyler, Texas, 75701, United States
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Salt Lake City, Utah, 84112, United States
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Richmond, Virginia, 23230, United States
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Tacoma, Washington, 98405, United States
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Edmonton, Alberta, T6G 1Z2, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Bordeaux, 33076, France
Research Site
Brest, 29609, France
Research Site
Bron, 69677, France
Research Site
Créteil, 94010, France
Research Site
La Rochelle, 17019, France
Research Site
Lille, 59037, France
Research Site
Limoges, 87042, France
Research Site
Lyon, 69004, France
Research Site
Marseille, 13015, France
Research Site
Nice, 06189, France
Research Site
Pierre-Bénite, 69495, France
Research Site
Rennes, 35033, France
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Strasbourg, 67065, France
Research Site
Toulouse, 31059, France
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Hong Kong, Hong Kong
Research Site
Jordan, Hong Kong
Research Site
Kowloon, Hong Kong
Research Site
Catania, 95125, Italy
Research Site
Cremona, 26100, Italy
Research Site
Milan, 20132, Italy
Research Site
Milan, 20133, Italy
Research Site
Palermo, 90127, Italy
Research Site
Ravenna, 48121, Italy
Research Site
Siena, 53100, Italy
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Gdynia, 81-519, Poland
Research Site
Lodz, 90-153, Poland
Research Site
Lodz, 90-242, Poland
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Lisbon, 1400-038, Portugal
Research Site
Lisbon, 1500-650, Portugal
Research Site
Porto, 4099-001, Portugal
Research Site
Porto, 4200-072, Portugal
Research Site
A Coruña, 15006, Spain
Research Site
Badajoz, 06008, Spain
Research Site
Barcelona, 08035, Spain
Research Site
Barcelona, 08041, Spain
Research Site
Barcelona, 08916, Spain
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Castellon, 12002, Spain
Research Site
Madrid, 28034, Spain
Research Site
Málaga, 29010, Spain
Research Site
Valencia, 46014, Spain
Research Site
Chiayi City, 61363, Taiwan
Research Site
Taichung, 402, Taiwan
Related Publications (2)
Aggarwal C, Martinez-Marti A, Majem M, Barlesi F, Carcereny E, Chu Q, Monnet I, Sanchez-Hernandez A, Dakhil S, Camidge DR, Pillet M, Brown M, Paliompeis C, Dowson A, Cooper ZA, Kumar R, Herbst RS. Durvalumab Alone or Combined With Novel Agents for Unresectable Stage III Non-Small Cell Lung Cancer: Update From the COAST Randomized Clinical Trial. JAMA Netw Open. 2025 Jul 1;8(7):e2518440. doi: 10.1001/jamanetworkopen.2025.18440.
PMID: 40663352DERIVEDHerbst RS, Majem M, Barlesi F, Carcereny E, Chu Q, Monnet I, Sanchez-Hernandez A, Dakhil S, Camidge DR, Winzer L, Soo-Hoo Y, Cooper ZA, Kumar R, Bothos J, Aggarwal C, Martinez-Marti A. COAST: An Open-Label, Phase II, Multidrug Platform Study of Durvalumab Alone or in Combination With Oleclumab or Monalizumab in Patients With Unresectable, Stage III Non-Small-Cell Lung Cancer. J Clin Oncol. 2022 Oct 10;40(29):3383-3393. doi: 10.1200/JCO.22.00227. Epub 2022 Apr 22.
PMID: 35452273DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca Clinical Study Information Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2018
First Posted
January 30, 2019
Study Start
December 19, 2018
Primary Completion
July 18, 2023
Study Completion
July 18, 2023
Last Updated
October 8, 2024
Results First Posted
October 8, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- 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.
- 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.
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.