RecruitingPhase 1Phase 2NCT07070440

DZD6008 Combination Therapy in Patients With Locally Advanced or Metastatic NSCLC With EGFR Mutation (TIAN-SHAN7)

A Phase 1/2, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 Combination Therapy in Patients With Locally Advanced or Metastatic NSCLC With EGFR Mutation (TIAN-SHAN7)


Sponsor

Dizal Pharmaceuticals

Enrollment

100 participants

Start Date

Jul 16, 2025

Study Type

INTERVENTIONAL

Summary

This study is designed to evaluate safety and antitumor activity of DZD6008 combination therapy in patients with advanced Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutations.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called DZD6008 in combination with other cancer medications for patients with advanced non-small cell lung cancer (NSCLC) that has a specific mutation in the EGFR gene. The goal is to find a more effective first-line treatment combination for this type of lung cancer. **You may be eligible if...** - You are 18 or older - You have advanced or metastatic non-squamous NSCLC confirmed by a lab test - Your cancer has a specific EGFR mutation (a gene change that drives the cancer) - You have not previously received treatment for advanced disease **You may NOT be eligible if...** - You have received prior treatment for advanced lung cancer - You have certain other EGFR mutations that are not covered by this drug - You have serious heart, liver, or lung problems 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

DZD6008 was administered orally at 40/60/90 mg QD.

DRUGPemetrexed

Pemetrexed 500 mg/m2, every 3 weeks, intravenous infusion.

DRUGCarboplatin

Carboplatin AUC 5 mg/mL/min, every 3 weeks, intravenous infusion.

DRUGDocetaxel

Docetaxel 75 mg/m2, every 3 weeks, intravenous infusion.


Locations(1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

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NCT07070440