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Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC

NCT ID: NCT03822351

Last Updated: 2024-10-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

189 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-19

Study Completion Date

2023-07-18

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Stage III Non-small Cell Lung Cancer Unresectable

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

At study onset subjects will be randomized equally to all study treatment arms open for enrollment and will remain on study treatment for up to 12 months.

Study treatment will be discontinued upon disease progression, unacceptable toxicity, or other reason. The treatment arms are Control Arm, Arm A and Arm B.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control Arm (Durvalumab monotherapy)

durvalumab IV

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

Durvalumab

Arm A (durvalumab + oleclumab):

durvalumab IV and oleclumab IV

Group Type EXPERIMENTAL

Durvalumab + Oleclumab

Intervention Type DRUG

Durvalumab + Oleclumab

Arm B (durvalumab + monalizumab)

durvalumab IV and monalizumab IV

Group Type EXPERIMENTAL

Durvalumab + Monalizumab

Intervention Type DRUG

Durvalumab + Monalizumab

Interventions

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Durvalumab + Oleclumab

Durvalumab + Oleclumab

Intervention Type DRUG

Durvalumab

Durvalumab

Intervention Type DRUG

Durvalumab + Monalizumab

Durvalumab + Monalizumab

Intervention Type DRUG

Other Intervention Names

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Durvalumab (MEDI-4736) Oleclumab (MEDI-9447) Durvalumab (MEDI-4736) Durvalumab (MEDI-4736) Monalizumab (IPH2201)

Eligibility Criteria

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Inclusion Criteria

1. Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluation
2. Age 18 years or older
3. Body weight ≥ 35 kg
4. Subjects must have histologically or cytologically documented NSCLC who present with locally advanced, unresectable, Stage III disease
5. Subjects must have completed, without progressing, definitive cCRT within 42 days prior to being randomized into the study
6. Provision of tumor tissue sample, when available, from original diagnosis obtained before initiation of chemoradiotherapy
7. Life expectancy ≥ 12 weeks
8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
9. Subjects must have at least one previously irradiated tumor lesion that can be measured by RECIST v1.1

Exclusion Criteria

1. Mixed small cell and non-small cell lung cancer histology
2. Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug
3. Prior exposure to any anti-PD1, anti-PD-L1, or anti-CTLA4 antibody for treatment of NSCLC
4. Subjects with history of ≥ Grade 2 pneumonitis from prior chemoradiation therapy
5. Subjects with a history of venous thrombosis within the past 3 months
6. Subjects with history of myocardial infarction, transient ischemic attack, or stroke in the past 6 months
7. Congestive heart failure
8. Active or prior documented autoimmune or inflammatory disorders
9. History of active primary immunodeficiency
10. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV)
11. History of allogenic organ transplantation
12. QTcF interval ≥ 470 ms
13. History of another primary malignancy
14. Concurrent enrollment in another clinical study \[concurrent enrollment in an observational (non-interventional) clinical study or during the follow-up period of an interventional study is permitted\]
15. Females who are pregnant, lactating, or intend to become pregnant during their participation in the study
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MedImmune LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Anaheim, California, United States

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Duarte, California, United States

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Sacramento, California, United States

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New Haven, Connecticut, United States

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West Haven, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Orlando, Florida, United States

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Winter Haven, Florida, United States

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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Covington, Louisiana, United States

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Rosedale, Maryland, United States

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Lincoln, Nebraska, United States

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New York, New York, United States

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New York, New York, United States

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Portland, Oregon, United States

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Gettysburg, Pennsylvania, United States

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Lancaster, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Sioux Falls, South Dakota, United States

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Germantown, Tennessee, United States

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Memphis, Tennessee, United States

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Tyler, Texas, United States

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Salt Lake City, Utah, United States

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Richmond, Virginia, United States

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Tacoma, Washington, United States

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Edmonton, Alberta, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Bordeaux, , France

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Brest, , France

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Bron, , France

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Créteil, , France

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La Rochelle, , France

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Lille, , France

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Limoges, , France

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Lyon, , France

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Marseille, , France

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Nice, , France

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Pierre-Bénite, , France

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Rennes, , France

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Strasbourg, , France

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Toulouse, , France

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Hong Kong, , Hong Kong

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Jordan, , Hong Kong

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Kowloon, , Hong Kong

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Catania, , Italy

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Cremona, , Italy

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Milan, , Italy

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Milan, , Italy

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Palermo, , Italy

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Ravenna, , Italy

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Siena, , Italy

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Gdynia, , Poland

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Lodz, , Poland

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Lodz, , Poland

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Lisbon, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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Porto, , Portugal

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A Coruña, , Spain

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Badajoz, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Castellon, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Valencia, , Spain

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Chiayi City, , Taiwan

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Taichung, , Taiwan

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Countries

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United States Canada France Hong Kong Italy Poland Portugal Spain Taiwan

References

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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.

Reference Type DERIVED
PMID: 40663352 (View on PubMed)

Herbst 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.

Reference Type DERIVED
PMID: 35452273 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9108C00001&attachmentIdentifier=de7dfeb7-8334-4784-8d4a-da8d429556aa&fileName=d9108c00001-csp-amendment-4_Redacted.pdf&versionIdentifier=

CSP redacted

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9108C00001&attachmentIdentifier=51d2c3e5-8514-4a79-907b-da0a3149d00c&fileName=D9108C00001_Statistical_Analysis_Plan_v5_Redacted.pdf&versionIdentifier=

SAP redacted

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9108C00001&attachmentIdentifier=f0bb70f9-6f4e-4554-b7e4-aafad3298d36&fileName=d9108c00001-study-synopsis_Redacted.pdf&versionIdentifier=

CSR Synopsis redacted

Other Identifiers

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2018-002931-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D9108C00001

Identifier Type: -

Identifier Source: org_study_id

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