Status:
COMPLETED
Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC
Lead Sponsor:
MedImmune LLC
Conditions:
Stage III Non-small Cell Lung Cancer
Unresectable
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
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 com...
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 agent...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
December 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2023
Estimated Enrollment :
189 Patients enrolled
Trial Details
Trial ID
NCT03822351
Start Date
December 19 2018
End Date
July 18 2023
Last Update
October 8 2024
Active Locations (73)
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1
Research Site
Anaheim, California, United States, 92801
2
Research Site
Duarte, California, United States, 91010
3
Research Site
Sacramento, California, United States, 95825
4
Research Site
New Haven, Connecticut, United States, 06510