NCT07079475

Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8)

A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 Combined With Sunvozertinib in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations (TIAN-SHAN8)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Dizal (Jiangsu) Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will treat patients with advanced NSCLC harboring EGFR mutations. This is the first study to test DZD6008 combined with sunvozertinib in patients, which will help to understand what type of side effects with the treatment. It will also measure the levels of two drugs in the body and preliminarily assess the anti-tumor activity with the combination treatment

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	DZD6008	DZD6008 will be administered orally at 40/60 mg QD or selected dose.
DRUG	Sunvozertinib	Sunvozertinib will be administered orally at 100 mg QD or selected dose.
DRUG	Osimertinib	Osimertinib will be administered orally at 80 mg QD

Timeline

• Start date: 2025-07-31
• Primary completion: 2028-12-01
• Completion: 2029-12-01
• First posted: 2025-07-23
• Last updated: 2025-12-24

Locations

4 sites across 1 country: China