NCT06813365

Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN2)

A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) With EGFR Mutation (TIAN-SHAN2)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Dizal Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to evaluate safety and antitumor activity of DZD6008 in patients with advanced NSCLC with EGFR mutations. This is the first time the drug is tested in human.

Detailed description

The study includes two parts: Part A (dose escalation) and Part B (dose expansion). In Part A, locally advanced or metastatic NSCLC patients with EGFR sensitizing mutations (Exon19del and/or L858R) following at least 1 prior EGFR TKI and platinum-based chemotherapy will be enrolled. In Part B, locally advanced or metastatic NSCLC patients with EGFR sensitizing mutations following 1 prior third-generation EGFR TKI and who are treatment naïve will be enrolled.

Conditions

• Nonsmall-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	DZD6008	Daily dose of DZD6008

Timeline

• Start date: 2024-06-12
• Primary completion: 2026-12-30
• Completion: 2028-07-30
• First posted: 2025-02-06
• Last updated: 2025-12-30

Locations

1 site across 1 country: China