Status:
RECRUITING
A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1)
Lead Sponsor:
Dizal Pharmaceuticals
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is designed to evaluate safety and anti-tumor activity of DZD6008 in patients with advanced NSCLC with EGFR mutations.
Detailed Description
The study includes two parts: Part A (dose escalation) and Part B(dose expansion). In Part A, locally advanced or metastatic NSCLC patients with EGFR sensitizing mutations (Exon19del and/or L858R) fol...
Eligibility Criteria
Inclusion
- Patients must be able to provide documented informed consent.
- Aged ≥ 18 years.
- Histologically or cytologically confirmed diagnosis of NSCLC, locally advanced or metastatic, not suitable for curative therapy.
- Documentation of EGFR sensitizing mutations (Exon19del and/or L858R) from a local CLIA-certified laboratory (or equivalent).
- Provide adequate amount of pretreatment tumor samples collected after disease progression on the last EGFR TKI treatment.
- Failed (progressed or are intolerant) from at least 1 prior EGFR TKI regimen.
- ECOG 0 or 1 with predicted life expectancy ≥ 12 weeks.
- Patients with brain metastases must have a stable BM status.
- Measurable disease per RECIST 1.1.
- Adequate hematopoietic and other organ system functions.
- Male Patients with female partners of childbearing potential should use barrier contraceptives and refrain from donating sperm during their participation in this study and for 3 months following the last dose of the study drug.
Exclusion
- Carry any other known EGFR alterations, including but not limited to uncommon EGFR mutations (G719X, S768I, L861Q, exon 20 insertions, etc.)(Part B).
- NSCLC with mixed small cell lung cancer (SCLC) or NSCLC with histologic SCLC transformation.
- Prior treatment with any of the following: 1)Immunotherapy or other antibody therapy within 4 weeks prior to the first administration; 2)Any cytotoxic chemotherapy, investigational drugs or other anticancer drugs from a previous treatment regimen or clinical study within 14 days prior to the first administration; 3)Radiotherapy with a limited field of radiation for palliation within 7 days of the first dose, radiation to more than 30% of the bone marrow or with a wide field of radiation within 28 days before screening; 4)Currently receiving or unable to stop drug or herbal supplements known to be potent inhibitors or inducers of cytochrome P450 (CYP)3A4. A washout period of at least 2 weeks for strong inhibitors and 3 weeks for strong inducers is required prior to the first study drug administration; 5)currently receiving or unable to stop drugs known to be CYP3A4 sensitive substrate with a narrow therapeutic index. A washout period of at least 14 days is required prior to the first study drug administration; 6)currently receiving or unable to stop drugs known to be proton pump inhibitors. A washout period of at least 7 days is required prior to the first study drug administration; 7)major surgery within 4 weeks of the first administration of DZD6008 or anticipated during the study period.
- Any unresolved toxicities from prior anti-cancer therapy greater than CTCAE Grade 1.
- Spinal cord compression or leptomeningeal metastasis.
- Patients with any other malignancy within 2 years of the first administration of study drug.
- Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses as judged by investigator.
- Patients with active infection, including but not limited to HBV, HCV, HIV and active infection of COVID-19.
- Resting QTcF \> 470 msec; Any clinically significant abnormalities in rhythm, conduction or morphology of resting ECG;Any factors that increase the risk of QTc prolongation.
- Past medical history of ILD or active ILD.
- Diseases which would preclude adequate absorption of DZD6008.
- Received a live vaccine within 2 weeks before the first administration of DZD6008.
- Women who are pregnant or breastfeeding.
- Hypersensitivity to active or inactive excipients of DZD6008.
- Involvement in the planning and conduct of the study.
- Judgment by the investigator that the patient is unlikely to comply with study procedures
Key Trial Info
Start Date :
May 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06905197
Start Date
May 13 2025
End Date
December 1 2028
Last Update
December 30 2025
Active Locations (5)
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1
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States, 10016
2
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
3
Virginia Cancer Specialist (NEXT Oncology-Virginia)
Fairfax, Virginia, United States, 22031
4
Blacktown Hospital
Blacktown, New South Wales, Australia, 2148