TIAN-SHAN1 Study: DZD6008 for Advanced NSCLC with EGFR Mutations

This study is testing a new oral medicine called DZD6008 for people with advanced non-small cell lung cancer (NSCLC) that has specific changes in the EGFR gene. It will also compare DZD6008 to another medicine called Sunvozertinib. The main goals are to see how safe DZD6008 is and how well it works to shrink tumors. To join, you must be at least 18 years old, have advanced NSCLC that can't be cured by other treatments, and have a confirmed EGFR gene mutation. The study is currently unclear about its recruitment status and plans to enroll about 140 people.

Study design
This study is an interventional study with a planned enrollment of 140 participants. It has two parts: Part A (dose escalation) and Part B (dose expansion).
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and anti-tumor activity will be measured through the study completion, which is an average of around 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06905197

A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1)

Recruiting
PHASE1Ages 18+InterventionalTreatment
Dizal Pharmaceuticals
~140 participants
Updated 2026-02-27 on ClinicalTrials.gov
What's tested:DZD6008Sunvozertinib

At a glance

Recruiting sites
2 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Part A: To assess safety and tolerability
Measured over 21 days after the first multiple dose
+2 more outcomes measured
Non Small Cell Lung Cancer
5 sites across 3 states
New York2
New South Wales2
Virginia1

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  • Part A: To assess safety and tolerability21 days after the first multiple dose

    Number of participants with Dose-limiting Toxicities (DLTs)

  • Part A: To assess safety and tolerabilityThrough the study completion, an average of around 1 year

    Number of participants with Adverse events (AEs)/Serious adverse events (SAEs)

  • Part B: To assess anti-tumor activityThrough the study completion, an average of around 1 year

    Objective Response Rate (ORR) assessed by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1