Actively Recruiting
Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN2)
Led by Dizal Pharmaceuticals · Updated on 2025-12-30
190
Participants Needed
1
Research Sites
215 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients able to provide documented informed consent
- Aged 18 years or older
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC not suitable for curative therapy
- Documented EGFR sensitizing mutation (Exon19del and/or L858R) from a certified laboratory
- Provide adequate pretreatment tumor samples for central confirmation of EGFR mutations
- Part A: Failed at least one prior EGFR TKI and platinum-based chemotherapy
- Part B: Cohorts 1 and 2 failed one prior third-generation EGFR TKI, cohorts 3 and 4 are treatment naive
- ECOG performance status 0 or 1 with life expectancy of at least 12 weeks
- Stable brain metastases if present
- Measurable disease per RECIST 1.1 criteria
- Adequate hematopoietic and organ function
- Male patients with female partners of childbearing potential must use barrier contraceptives and avoid sperm donation during and for three months after the study
You will not qualify if you...
- Presence of other EGFR mutations including uncommon mutations (e.g., G719X, S768I, L861Q, exon 20 insertions) in Part B
- NSCLC mixed with small cell lung cancer or histologic transformation to small cell lung cancer
- Prior immunotherapy or antibody therapy within 4 weeks before first dose
- Prior cytotoxic chemotherapy, investigational drugs, or anticancer drugs within 14 days before first dose
- Radiotherapy within specified time frames before screening (varies by radiation field and dose)
- Current use or inability to stop drugs affecting CYP3A4 enzyme or proton pump inhibitors without required washout periods
- Major surgery within 4 weeks before first dose or planned during study
- Unresolved toxicities from prior anticancer therapy above Grade 1
- Spinal cord compression or leptomeningeal metastasis
- Other malignancies within 2 years before first dose
- Severe or uncontrolled systemic diseases including uncontrolled hypertension or active bleeding
- Active infections including HBV, HCV, HIV, or COVID-19
- Resting QTcF > 470 msec or other significant ECG abnormalities
- History or active interstitial lung disease
- Conditions preventing adequate absorption of DZD6008
- Pregnant or breastfeeding women
- Hypersensitivity to DZD6008 or its components
- Involvement in study planning or conduct
- Investigator judgment that patient may not comply with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100005
Actively Recruiting
Research Team
H
Hui Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
10
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