Durvalumab vs Placebo Following Stereotactic Body Radiation Therapy in Early Stage Non-small Cell Lung Cancer Patients

Patients who complete definitive treatment with SoC SBRT and are confirmed to meet all
eligibility criteria will be randomized 1:1 to durvalumab or placebo.

The primary objective of this study is to assess the efficacy of durvalumab monotherapy
compared to placebo in terms of PFS. Key secondary is to assess the efficacy of Durvalumab
monotherapy compared to placebo in terms of OS.

Key Inclusion Criteria:

1. Age ≥18 years

2. Histologically or cytologically documented Stage I to II NSCLC, with clinical Stage
I/II lymph node-negative (T1 to T3N0M0) disease and planned to receive definitive
treatment with SBRT. Patients may be medically inoperable or are medically operable
and refusing surgery or choosing to have SBRT (Stereotactic Body Radiation Therapy) as
definitive therapy

3. Completion of SoC SBRT as definitive treatment prior to randomization

4. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) PS of 0, 1,
or 2

5. Life expectancy of at least 12 weeks

6. Body weight >30 kg

7. Tumor sample required

8. Adequate organ and marrow function required

9. Patients with central or peripheral lesions are eligible

10. Staging studies must be done within 8 weeks before randomization

Key Exclusion Criteria:

1. Mixed small cell and non-small cell cancer histology

2. History of allogeneic organ transplantation

3. History of another primary malignancy with exceptions

4. History of active primary immunodeficiency

5. Any unresolved toxicity National Cancer Institute (NCI) CTCAE Grade ≥2 from SBRT
(Stereotactic Body Radiation Therapy)