Actively Recruiting
A Phase 1, Open-Label Study to Assess Safety and Anti-tumor Activity of DZD6008 in Advanced NSCLC With EGFR Mutations
Led by Dizal Pharmaceuticals · Updated on 2026-02-27
140
Participants Needed
5
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and anti-tumor activity of DZD6008, an oral EGFR inhibitor, in patients with advanced non-small cell lung cancer (NSCLC) that have EGFR mutations. This Phase 1, open-label study includes patients with locally advanced or metastatic NSCLC who have specific EGFR mutations and either have been previously treated with EGFR tyrosine kinase inhibitors (TKIs) or are treatment-naïve. The study aims to better understand how DZD6008 works in this patient group and assess its tolerability and anti-cancer effects. The study has two parts: Part A focuses on dose escalation, enrolling patients who have failed at least one prior EGFR TKI therapy. Multiple dose levels of DZD6008 are tested, ranging from 20 mg to 150 mg daily, including combination cohorts. Part B is a dose expansion phase that includes patients who have either failed one line of third-generation EGFR TKI or are treatment-naïve, to further evaluate selected doses of DZD6008. Participants take the study drug orally once daily during these periods. Participants will undergo regular safety and tumor assessments throughout the study, typically for about one year. Researchers will monitor blood levels of DZD6008 and its metabolites, assess tumor response using RECIST 1.1 criteria, and evaluate overall tolerability. Safety evaluations include laboratory tests, ECGs, and monitoring for adverse events. The study collects tumor samples before treatment and tracks disease progression and patient well-being during follow-up.
CONDITIONS
Brief 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
- Age 18 years or older
- Confirmed diagnosis of locally advanced or metastatic NSCLC not suitable for curative therapy
- Documented EGFR sensitizing mutations (Exon19del and/or L858R) from a certified laboratory
- Provide adequate pretreatment tumor samples after progression or before study treatment
- Failed at least one prior EGFR TKI regimen (Part A) or failed one prior third-generation EGFR TKI or treatment-naïve (Part B)
- 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
- Adequate blood and organ function
- Male patients with female partners of childbearing potential should use barrier contraceptives and avoid sperm donation during and for 3 months after treatment
You will not qualify if you...
- EGFR mutations other than T790M and C797X, including uncommon mutations (Part B)
- NSCLC with mixed small cell lung cancer or histologic transformation to small cell lung cancer
- Recent immunotherapy or antibody treatment within 4 weeks before first dose
- Recent cytotoxic chemotherapy, investigational drugs, or anticancer drugs within 14 days before first dose
- Recent radiotherapy within 7 to 28 days before first dose depending on field size
- Current use or inability to stop drugs or supplements affecting CYP3A4 within required washout periods
- Major surgery within 4 weeks before first dose or planned during study
- Unresolved toxicities from prior anti-cancer therapy greater than Grade 1
- Spinal cord compression or leptomeningeal metastasis
- Other malignancies within 2 years before first dose
- Severe or uncontrolled systemic diseases
- Active infections including HBV, HCV, HIV, or COVID-19
- Resting QTcF > 470 msec or significant ECG abnormalities
- 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 components
- 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Up to approximately 1 year depending on study completion
Participants receive daily doses of DZD6008 alone or in combination with Sunvozertinib to assess safety, tolerability, and anti-tumor activity.
Visits occur regularly throughout treatment cycles, each cycle lasting 21 days
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
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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