Dr. Geoffrey Liu
Inclusion Criteria:
1. Aged at least 18 years old (or per local regulatory/IRB requirement).
2. Histologically or cytologically confirmed diagnosis of non-squamous NSCLC, locally
advanced (Stage IIIB and IIIC according to the 8th edition of the AJCC TNM staging
criteria) or metastatic (Stage IV), not suitable for curative therapy.
3. Adequate tumor tissue available, for central laboratory confirmation of EGFR exon 20
insertion mutation
4. At least 1 measurable lesion per RECIST Version 1.1
5. Life expectancy ≥ 12 weeks
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
7. Adequate organ and hematologic function
Exclusion Criteria:
1. Prior treatment with any systemic anti-cancer therapy for locally advanced or
metastatic NSCLC.
2. Spinal cord compression or leptomeningeal metastasis.
3. Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.
4. History of stroke or intracranial hemorrhage within 6 months before randomization.
5. As judged by the investigator, any evidence of severe or uncontrolled systemic
diseases, including uncontrolled hypertension and active bleeding diatheses (i.e.,
hemophilia and Von Willebrand disease).
