RecruitingPhase 1NCT06813365

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)


Sponsor

Dizal Pharmaceuticals

Enrollment

190 participants

Start Date

Jun 12, 2024

Study Type

INTERVENTIONAL

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new oral pill called DZD6008 for adults with advanced non-small cell lung cancer (NSCLC) that has a specific genetic change called an EGFR mutation. EGFR mutations tell cancer cells to grow, and drugs that block this signal can slow the cancer. Researchers want to find out if DZD6008 is safe and effective, especially for people whose cancer stopped responding to previous EGFR-targeting drugs. **You may be eligible if...** - You are 18 or older with confirmed advanced or metastatic NSCLC - Your tumor has a specific EGFR mutation (Exon 19 deletion or L858R) - You have already tried at least one EGFR-targeted drug and/or chemotherapy (for some parts of the study), or you have not yet started treatment (for other parts) - Your cancer is measurable on scans and you are reasonably functional day-to-day **You may NOT be eligible if...** - Your cancer has a different or unusual EGFR mutation type - Your lung cancer has mixed small cell features - You have had certain other cancers within the past 2 years - You have active infections such as HIV, hepatitis B or C, or active COVID-19 - You have a history of serious lung inflammation (interstitial lung disease) 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


Locations(1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

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NCT06813365