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

Sponsor
Dizal (Jiangsu) Pharmaceutical Co., Ltd.
Study ID
NCT07079475
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • DZD6008 — DRUG
    DZD6008 will be administered orally at 40/60 mg QD or selected dose.
  • Sunvozertinib — DRUG
    Sunvozertinib will be administered orally at 100/200 mg QD or selected dose.
  • Osimertinib — DRUG
    Osimertinib will be administered orally at 80 mg QD

Study Details

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

Key Dates

Start date
Jul 30, 2025
Status verified
May 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
160 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: DZD6008 + Sunvozertinib
  • Active Comparator: Osimertinib

Primary Outcome Measure

Part A: To assess safety and tolerability [ Time Frame: Through the study completion, an average of around 2 years ]

Central Contacts

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