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A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab With Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients With Unresected Stage I/II, Lymph-node Negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515) Osimertinib Following SBRT, a Single Arm Cohort for Patients With Unresected Stage I/II, Lymph Node Negative NSCLC Harboring a Sensitizing EGFR Mutation
The main part of this study is recruiting people with stage I/II lymph node negative (T1 to T3N0M0) non-small cell lung cancer who have not had prior therapy. This main study will randomly assign eligible participants to either the Experimental Arm or the Placebo Comparator Arm. In the Experimental Arm, participants will receive standard-of-care stereotactic body radiation therapy (SBRT) plus immunotherapy (durvalumab). SBRT will be delivered in 3, 4, 5 or 8 fractions. Durvalumab will be given at a dose of 1500mg every 4 weeks intravenously.
In the Placebo Comparator Arm, participants will receive standard of care SBRT plus a placebo. SBRT will be delivered in 3, 4, 5 or 8 fractions. The Placebo will be given every 4 weeks via IV.
In addition to this main study, an additional cohort will recruit participants with stage I/II lymph node-negative non-small cell lung cancer harbouring an EGFR mutation who have not had prior therapy. This cohort will receive standard of care SBRT followed by targeted therapy (osimertinib). SBRT will be delivered in 3, 4, 5 or 8 fractions. Osimertinib will be given at a dose of 80mg every day via oral tablet for up to 36 months.