A Study of DZD9008 Versus Platinum-Based Doublet Chemotherapy in Local Advanced or Metastatic Non-small Cell Lung Cancer (WU-KONG28)

Inclusion Criteria

• Aged at least 18 years old (or per local regulatory/IRB requirement).
• 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.
• Adequate tumor tissue available, for central laboratory confirmation of EGFR exon 20 insertion mutation
• At least 1 measurable lesion per RECIST Version 1.1
• Life expectancy ≥ 12 weeks
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
• Adequate organ and hematologic function

Exclusion Criteria

• Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC.
• Spinal cord compression or leptomeningeal metastasis.
• Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.
• History of stroke or intracranial hemorrhage within 6 months before randomization.
• 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).