RecruitingPhase 1Phase 2NCT07079475

Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8)

A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 Combined With Sunvozertinib in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations (TIAN-SHAN8)


Sponsor

Dizal (Jiangsu) Pharmaceutical Co., Ltd.

Enrollment

200 participants

Start Date

Jul 31, 2025

Study Type

INTERVENTIONAL

Summary

This study will treat patients with advanced NSCLC harboring EGFR mutations. This is the first study to test DZD6008 combined with sunvozertinib in patients, which will help to understand what type of side effects with the treatment. It will also measure the levels of two drugs in the body and preliminarily assess the anti-tumor activity with the combination treatment


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of two oral targeted drugs — DZD6008 and sunvozertinib — in people with advanced non-small cell lung cancer (NSCLC) whose tumors have specific genetic mutations in a gene called EGFR, and whose cancer has stopped responding to standard EGFR-targeted treatments. **You may be eligible if...** - You are 18 or older with advanced or metastatic non-squamous NSCLC - Your tumor has a confirmed EGFR mutation - You have previously received and progressed on EGFR-targeted therapy (specific requirements vary by study group) - Your cancer is stable in the brain (if brain metastases are present) and you have measurable disease **You may NOT be eligible if...** - You have mixed small-cell and non-small-cell lung cancer - You have certain prior treatment histories (e.g., two or more prior third-generation EGFR inhibitors) - You have active lung inflammation (ILD), active infections (HBV, HCV, HIV), or a history of severe heart rhythm abnormalities - 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

DZD6008 will be administered orally at 40/60 mg QD or selected dose.

DRUGSunvozertinib

Sunvozertinib will be administered orally at 100 mg QD or selected dose.

DRUGOsimertinib

Osimertinib will be administered orally at 80 mg QD


Locations(4)

Beijing Chest Hospital

Beijing, Beijing Municipality, China

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Zhejiang Taizhou Hospital

Taizhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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NCT07079475