RecruitingPhase 1NCT06905197

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

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 Mutations (TIAN-SHAN1)


Sponsor

Dizal Pharmaceuticals

Enrollment

140 participants

Start Date

May 13, 2025

Study Type

INTERVENTIONAL

Summary

This study is designed to evaluate safety and anti-tumor activity of DZD6008 in patients with advanced NSCLC with EGFR mutations.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new oral targeted drug called DZD6008 for people with advanced non-small cell lung cancer (NSCLC) that has a specific gene mutation called an EGFR mutation — either as a first treatment or after prior targeted therapy has stopped working. **You may be eligible if...** - You are 18 or older - You have advanced or metastatic non-small cell lung cancer confirmed by biopsy - Your tumor has a confirmed EGFR mutation (such as Exon 19 deletion or L858R) - If previously treated: your prior EGFR-targeted therapy has stopped working or you could not tolerate it - You can provide tumor tissue samples **You may NOT be eligible if...** - Your cancer does not have an EGFR mutation - You have serious organ problems or other major health conditions - You are unable to take oral medication - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDZD6008

Daily dose of DZD6008

DRUGSunvozertinib

Daily dose of Sunvozertinib


Locations(5)

Laura and Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, United States

Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Virginia Cancer Specialist (NEXT Oncology-Virginia)

Fairfax, Virginia, United States

Blacktown Hospital

Blacktown, New South Wales, Australia

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06905197