Actively Recruiting
Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8)
Led by Dizal (Jiangsu) Pharmaceutical Co., Ltd. · Updated on 2026-05-11
200
Participants Needed
7
Research Sites
174 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8)
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 non-squamous NSCLC, locally advanced or metastatic, not suitable for curative therapy
- Documented EGFR mutation confirmed by a certified laboratory; Part A: EGFR mutations excluding only exon20ins; Part B: EGFR sensitizing mutations (Exon19del and/or L858R) with or without T790M/C797S resistance mutations
- Provide adequate baseline tumor and plasma samples, collected after progression on last EGFR TKI treatment for Part A and B1/B2 cohorts; collected before study treatment for B3 cohort
- For Part A, B1, and B2 cohorts: failed or intolerant to one line of third-generation EGFR TKI (e.g., Osimertinib), with or without prior platinum-based chemotherapy; no more than 2 lines of EGFR TKI and no more than 3 lines of systemic therapy allowed
- For B3 cohort: no prior systemic anti-tumor therapy
- ECOG performance status 0 or 1 with predicted life expectancy of at least 12 weeks
- Stable brain metastases at study entry
- Measurable disease per RECIST 1.1
- Adequate hematopoietic and organ function
You will not qualify if you...
- NSCLC with mixed small-cell lung cancer or histologic transformation to small-cell lung cancer
- For Part A: participants only with EGFR exon20ins mutation
- Prior treatment with two or more lines of third-generation EGFR TKI
- Prior systemic anti-cancer therapy for advanced disease (for B3 cohort)
- Immunotherapy or antibody therapy within 4 weeks before first dose
- Cytotoxic chemotherapy, investigational or other anticancer drugs within 14 days before first dose
- Radiotherapy with limited field within 7 days or wide field radiation within 28 days before first dose
- Use of strong CYP3A4 inhibitors or inducers without washout period before first dose
- Use of drugs sensitive to CYP3A4 with narrow therapeutic index without washout
- Use of proton-pump inhibitors without washout
- Major surgery within 4 weeks before or anticipated during study
- Unresolved toxicities from prior anti-cancer therapy above CTCAE Grade 1
- Spinal cord compression or leptomeningeal metastasis
- Any other malignancy within 2 years before first dose
- Severe or uncontrolled systemic diseases including hypertension and bleeding diatheses
- Active infections including HBV, HCV, or HIV
- Resting QTcF above 470 msec or significant ECG abnormalities
- Past or active interstitial lung disease
- Diseases preventing adequate drug absorption
- Live vaccine within 2 weeks before first dose
- Pregnant or breastfeeding women
- Hypersensitivity to study drugs or their excipients
AI-Screening
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Trial Site Locations
Total: 7 locations
1
Beijing Chest Hospital
Beijing, Beijing Municipality, China, 101125
Actively Recruiting
2
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Not Yet Recruiting
3
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
4
Sichuan Cancer Hospital
Chengdu, Sichuan, China, 6100042
Not Yet Recruiting
5
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China, 300060
Not Yet Recruiting
6
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, China, 310005
Actively Recruiting
7
Zhejiang Taizhou Hospital
Taizhou, Zhejiang, China, 317000
Actively Recruiting
Research Team
Y
YIFAN LIU
CONTACT
C
clinicaltrials@dizalpharma.com
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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