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Phase 2, Open-Label, Multicenter, Randomized, Multi-Drug Platform Study of Durvalumab Alone or in Combination with Novel Agents in Subject with Locally Advanced, Unresectable, Stage III Non-Small Cell Lung Cancer (COAST)
Description
This randomized trial studies whether or not the medication called durvalumab and other novel agents will work and be safe for the treatment of unresectable NSCLC.
Learn more at clinicaltrials.gov
Eligibility Criteria
Inclusion
Written informed consent and any locally required authorization obtained from the subject prior to performing any protocol-related procedures, including screening evaluation.
- 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 28 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
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.
- 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
- QTc 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