Table 1 Key inclusion and exclusion criteria
Key inclusion criteria | ||
|---|---|---|
T790M cohort | First-line cohort | |
✓ | Histologically or cytologically confirmed non-small cell lung cancer | |
✓ | Confirmed EGFR mutations (exon 19 deletion, exon 21 L858R point mutation) | |
✓ | Radiological disease progression following first- or second-generation EGFR-TKIs | Previously untreated with EGFR-TKIs |
✓ | Confirmed EGFR T790M mutation detected from tumor or plasma sample after disease progression from prior treatment | |
✓ | Stage IV or postoperative relapse | |
✓ | Patients must have a brain metastasis lesion of 5 mm or more in size in the long axis irrespective of the presence of extracranial metastases Patients with brain metastasis requiring emergent therapy are excluded | |
✓ | No prior radiation therapy for brain metastasis | |
✓ | Patients aged at least 20 years at the time of informed consent | |
✓ | ECOG performance status 0–2 | |
✓ | Adequate organ function | |
✓ | Mean corrected QT interval not exceeding 471 ms | |
✓ | Written informed consent obtained from the patient | |
Key exclusion criteria | ||
✓ | Symptomatic brain metastasis requiring radiation therapy or surgical resection | |
✓ | Severe complications | |
✓ | Presence of active double cancers (synchronous cancers and metachronous cancers with a disease-free interval of no more than 5 years) | |
✓ | Prior treatment with anti-PD-1, anti-PD-L1, anti-CD137, and anti-CTLA-4 antibody | |
✓ | Pregnancy or planned or expected pregnancy | |
✓ | Lactation in women | |
✓ | History of interstitial lung disease, drug-induced interstitial lung disease, and radiation pneumonitis requiring steroid treatment | |
✓ | Presence of symptomatic superior vena cava syndrome | |
✓ | Presence of psychiatric disorder or mental symptoms | |
✓ | History of hypersensitivity to osimertinib and any excipients of osimertinib | |