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

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).

Main 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 28 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. Subjects with history of ≥ Grade 2 pneumonitis from prior chemoradiation therapy

4. Subjects with a history of venous thrombosis within the past 3 months

5. Subjects with history of myocardial infarction, transient ischemic attack, or stroke
in the past 6 months

6. Congestive heart failure

7. Active or prior documented autoimmune or inflammatory disorders

8. History of active primary immunodeficiency

9. Active infection including tuberculosis, hepatitis B, hepatitis C, or human
immunodeficiency virus (HIV)

10. History of allogenic organ transplantation

11. QTcF interval ≥ 470 ms

12. History of another primary malignancy

13. Concurrent enrollment in another therapeutic clinical study or during the follow-up
period of an interventional study. Enrollment in observational studies will be allowed

14. Females who are pregnant, lactating, or intend to become pregnant during their
participation in the study