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
This is a Phase III, randomized, placebo-controlled, double-blind, multi-center study assessing the efficacy and safety of durvalumab with SoC SBRT versus placebo with SoC SBRT in patients with unresected clinical Stage I/II lymph node-negative (T1 to T3N0M0) NSCLC. An additional cohort will assess Osimertinib following SBRT in patients with early stage unresected T1 to T3N0M0 NSCLC harbouring an EGFR mutation.
• Age ≥18 years
• Planned SoC SBRT as definitive treatment
• World Health Organization (WHO)/ECOG PS of 0, 1 or 2
• Life expectancy of at least 12 weeks
• Body weight \>30 kg
• Submission of tumor tissue sample if available
• Adequate organ and marrow function required
• Patients with central or peripheral lesions are eligible
• Staging studies must be done during screening (PET-CT within 10 weeks)
⁃ Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions
• Age ≥18 years
• Planned SoC SBRT as definitive treatment
• WHO/ECOG PS of 0, 1, or 2
• Patients with central or peripheral lesions are eligible
• Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions
• Staging studies must be done during screening (PET-CT within 10 weeks)
• Submission of tumor tissue sample if available
• Confirmation by local laboratory that the tumor harbors one of the 2 common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R)
• Adequate bone marrow reserve or organ function required
⁃ Female patients should be using highly effective contraceptive measures
⁃ Male patients should be asked to use barrier contraceptives (ie, condoms) during sex with all partners during the trial and avoid procreation