Durvalumab Alone or in Combination with Novel Agents in Subjects with NSCLC - COAST

Study identifier:D9108C00001

ClinicalTrials.gov identifier:NCT03822351

EudraCT identifier:2018-002931-35

CTIS identifier:N/A

Study Complete

Official Title

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)

Medical condition

Stage III Non-small Cell Lung Cancer

Phase

Phase 2

Healthy volunteers

Study drug

Durvalumab + Oleclumab, Durvalumab, Durvalumab + Monalizumab

Sex

All

Actual Enrollment

189

Study type

Interventional

Age

18 Years - 99 Years

Date

Study Start Date: 19 Dec 2018

Primary Completion Date: 18 Jul 2023

Study Completion Date: 18 Jul 2023

Study design

Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment

Verification:

Verified 01 Oct 2024 by MedImmune, LLC

Collaborators

Inclusion and exclusion criteria

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
Main

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

No locations available

Arms	Assigned Interventions
Experimental: Control Arm (Durvalumab monotherapy) durvalumab IV	Drug: Durvalumab Durvalumab Other Name: Durvalumab (MEDI-4736)
Experimental: Arm A (durvalumab + oleclumab): durvalumab IV and oleclumab IV	Drug: Durvalumab + Oleclumab Durvalumab + Oleclumab Other Name: Durvalumab (MEDI-4736) Other Name: Oleclumab (MEDI-9447)
Experimental: Arm B (durvalumab + monalizumab) durvalumab IV and monalizumab IV	Drug: Durvalumab + Monalizumab Durvalumab + Monalizumab Other Name: Durvalumab (MEDI-4736) Other Name: Monalizumab (IPH2201)

Documents available

CSP redacted
Download
SAP redacted
Download
CSR Synopsis redacted
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

[email protected]