ZONGERTINIB

NCT04886804 📎

Regimen

Experimental
Phase Ia - Dose escalation part
Control
Phase Ib - Dose expansion part: Cohort 1

Population

HER2-mutant advanced/metastatic NSCLC, previously treated (phase 1a-1b)

Key finding

Oral HER2-selective TKI in HER2-mutated NSCLC: ORR 71%, mPFS 12.4 mo — FDA accelerated 2025.

Source: PMID 40293180

Timeline

  • Enrollment start: 2021-07-02 📎

Guideline citations

  • NCCN NSCLC Version 5.2026 (p.4)
  • CSCO NSCLC 2025 ⚠️ OCR source