Actively Recruiting
DZD6008 Combination Therapy in Patients With Locally Advanced or Metastatic NSCLC With EGFR Mutation (TIAN-SHAN7)
Led by Dizal Pharmaceuticals · Updated on 2025-08-29
100
Participants Needed
1
Research Sites
176 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 combination therapy in patients with advanced Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutations.
CONDITIONS
Official Title
DZD6008 Combination Therapy in Patients With Locally Advanced or Metastatic NSCLC With EGFR Mutation (TIAN-SHAN7)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent.
- Age 18 years or older.
- Diagnosed with locally advanced or metastatic non-squamous non-small cell lung cancer by histopathology or cytology, not suitable for other radical treatment.
- Documented EGFR sensitizing mutation confirmed by local laboratory.
- Able to provide sufficient tumor tissue and plasma samples for EGFR mutation analysis.
- Have failed prior treatment with three generations of EGFR tyrosine kinase inhibitors.
- ECOG performance status score of 0-1 and life expectancy of at least 12 weeks.
- No central nervous system symptoms during screening and no need for corticosteroids or dehydration diuretics for at least 4 weeks before first dosing; if brain metastases treated by radiotherapy or surgery, at least 2 weeks washout and recovery to grade 1 or less adverse events.
- Presence of measurable lesions defined by RECIST 1.1.
- Sufficient bone marrow and organ function before first dosing.
You will not qualify if you...
- Histology mixed with small cell lung cancer or transformation to small cell lung cancer.
- Received immunotherapy or antibody treatments within 4 weeks before first study drug administration.
- Received cytotoxic chemotherapy, study drugs, or other anti-cancer drugs (excluding macromolecules) within 14 days before first study drug administration.
- Received limited-range radiotherapy within 7 days or wide-range radiotherapy affecting more than 30% of bone marrow within 28 days before first medication.
- Taking or unable to stop strong CYP3A4 inhibitors or inducers within 2 to 3 weeks before first drug administration.
- Taking or unable to stop CYP3A4 sensitive substrate drugs within 2 weeks before first drug administration.
- Taking or unable to stop proton pump inhibitors within 1 week before first drug administration.
- Major invasive surgery within 4 weeks before first drug administration or planned during treatment.
- Presence of grade 1 or higher adverse events from previous treatments (except alopecia).
- Tumor-related spinal cord compression or meningeal metastasis.
- History of malignant tumors within 2 years (with some exceptions).
- Severe or uncontrolled systemic diseases including uncontrolled hypertension or bleeding disorders.
- Persistent or active infections including hepatitis B, hepatitis C, or HIV.
- Specific heart diseases or ECG abnormalities including prolonged QT interval, heart blocks, arrhythmias, severe cardiovascular diseases within 6 months, or recent deep vein thrombosis or pulmonary embolism within 4 weeks.
- History of interstitial lung disease, drug-induced lung disease, radiation pneumonitis requiring steroids, or active pneumonitis.
- Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing, or prior intestinal surgery affecting drug absorption.
- Live vaccine within 4 weeks before first dose.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
Y
Yuanli Dong
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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