Durvalumab With Stereotactic Body Radiation Therapy (SBRT) vs Placebo With SBRT in Early Stage Unresected Non-small Cell Lung Cancer (NSCLC) Patients/ Osimertinib Following SBRT in Patients With Early Stage Unresected NSCLC Harboring an EGFR Mutation

Criteria the registry did not label

• Main Cohort Key Inclusion Criteria:
• 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
  • Main Cohort Key Exclusion Criteria:
• Mixed small cell and non-small cell cancer
• History of allogeneic organ transplantation
• History of another primary malignancy with exceptions
• History of active primary immunodeficiency
• Epidermal growth factor receptor local testing is strongly recommended prior to enrollment. Patients with a tumor harboring an EGFRm per local testing will be excluded from the main cohort
• Prior exposure to immune-mediated therapy with exceptions
  • Osimertinib Cohort Key Inclusion Criteria
• 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
  • Osimertinib Cohort Key Exclusion Criteria
• Mixed small cell and non-small cell cancer
• Patients with known or increased risk factor for QTc prolongation
• Treatment with any of the following:
  • Preoperative or adjuvant platinum-based or other chemotherapy for the disease under investigation
  • Prior treatment with neoadjuvant or adjuvant EGFR TKI
  • Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4
• Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib
• Any of the following cardiac criteria
  • Mean resting corrected QT interval \>470 msec, obtained from 3 ECGs
  • Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.
  • Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained -sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval
  • Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD