Actively Recruiting
A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1)
Led by Dizal Pharmaceuticals · Updated on 2026-02-27
140
Participants Needed
5
Research Sites
185 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is designed to evaluate safety and anti-tumor activity of DZD6008 in patients with advanced NSCLC with EGFR mutations.
CONDITIONS
Official Title
A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide documented informed consent
- Aged 18 years or older
- Histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC not suitable for curative therapy
- Documented EGFR mutations from a certified laboratory; for Part A and all Part B cohorts, EGFR sensitizing mutations (Exon19del and/or L858R) required
- Provide adequate pretreatment tumor samples collected after progression on last EGFR TKI or before study treatment if treatment naive
- Part A: failed (progressed or intolerant) at least 1 prior EGFR TKI regimen; Part B Cohort A: failed 1 prior third-generation EGFR TKI; Part B Cohort B: treatment naive
- ECOG performance status 0 or 1 with predicted 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 contraception and avoid sperm donation during study and for 3 months after last dose
You will not qualify if you...
- Have EGFR alterations other than T790M and C797X, including uncommon mutations (e.g., G719X, S768I, L861Q, exon 20 insertions) in Part B
- NSCLC with mixed small cell lung cancer or with small cell lung cancer transformation
- Prior immunotherapy or antibody therapy within 4 weeks before first dose
- Any cytotoxic chemotherapy, investigational drugs, or other anticancer drugs within 14 days before first dose
- Radiotherapy within 7 days (limited field) or 28 days (wide field or >30% bone marrow) before screening
- Receiving or unable to stop drugs/herbal supplements that strongly inhibit or induce CYP3A4 without required washout
- Receiving or unable to stop drugs that are sensitive CYP3A4 substrates with narrow therapeutic index without 14-day washout
- Receiving or unable to stop proton pump inhibitors without 7-day washout
- Major surgery within 4 weeks before first dose or planned during study
- Unresolved toxicities from prior anticancer therapy greater than Grade 1
- Spinal cord compression or leptomeningeal metastasis
- Other malignancy 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 significant ECG abnormalities increasing risk of QT prolongation
- Past or active interstitial lung disease
- Conditions preventing adequate absorption of DZD6008
- Live vaccine within 2 weeks before first dose
- Pregnant or breastfeeding women
- Hypersensitivity to DZD6008 or Sunvozertinib ingredients
- Involvement in study planning or conduct
- Investigator judgment of likely non-compliance with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
2
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Actively Recruiting
3
Virginia Cancer Specialist (NEXT Oncology-Virginia)
Fairfax, Virginia, United States, 22031
Active, Not Recruiting
4
Blacktown Hospital
Blacktown, New South Wales, Australia, 2148
Active, Not Recruiting
5
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
Not Yet Recruiting
Research Team
Y
Yifan Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
13
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