NCT03974022

Assessing an Oral EGFR Inhibitor, Sunvozertinib in Patients Who Have Advanced Non-small Cell Lung Cancer With EGFR or HER2 Mutation (WU-KONG1)

A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of DZD9008 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With EGFR or HER2 Mutation

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 315 (actual)
• Sponsor: Dizal Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will treat patients with advanced NSCLC with EGFR or HER2 mutation who have progressed following prior therapy. This is the first time this drug is tested in patients, and so it will help to understand what type of side effects may occur with the drug treatment. It will also measure the levels of drug in the body and preliminarily assess its anti-cancer activity as monotherapy.

Detailed description

A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Anti-tumor Efficacy of Sunvozertinib in Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with EGFR or HER2 mutation. This study includes dose escalation, dose expansion, food effect (Part A) and dose extension (Part B).

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Sunvozertinib	Daily dose of Sunvozertinib

Timeline

• Start date: 2019-07-09
• Primary completion: 2024-07-29
• Completion: 2026-12-01
• First posted: 2019-06-04
• Last updated: 2026-01-29
• Results posted: 2025-12-03

Locations

124 sites across 13 countries: United States, Argentina, Australia, Canada, Chile, China, France, Italy, Japan, Malaysia, South Korea, Spain, Taiwan

Regulatory

• FDA-regulated drug study