Table 1.

Key Eligibility Criteria for Groups A and B

Inclusion Criteria	Exclusion Criteria
Adults aged ≥ 18 years (≥ 20 years in Japan)	Patients whose disease has progressed within the first 3 months of osimertinib treatment
Locally advanced/metastatic NSCLC not amenable to curative surgery or radiotherapy at study entry	Prior/concurrent treatment with any systemic anticancer therapy for advanced/metastatic NSCLC (except osimertinib)
Evidence of radiological disease progression on first-line monotherapy with osimertinib 80 mg once daily	History of diagnosis with another primary malignancy (e.g. SCLC or SCC)
Suitable for mandatory biopsy	Inadequate bone marrow reserve or organ function
Measurable disease per RECIST 1.1	Past medical history of ILD, drug induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD
Histologically/cytologically confirmed adenocarcinoma of the lung harboring EGFR mutation(s) known to be associated with EGFR-TKI sensitivity at diagnosis	Patients with spinal cord compression, symptomatic and unstable brain metastases, except those who have completed definitive therapy, are not on steroids and have a stable neurologic status for at least 2 weeks after completion of the definitive therapy and steroids
WHO performance status of 0/1

Abbreviations: EGFR = epidermal growth factor receptor; EGFR-TKI = epidermal growth factor receptor tyrosine kinase inhibitor; ILD = interstitial lung disease; NSCLC = non-small cell lung cancer; RECIST = Response Evaluation Criteria in Solid Tumours; SCC = squamous cell carcinoma; SCLC = small cell lung cancer; WHO = World Health Organization