> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-multinational-study-assessing-an-oral-egfr-inhibitor-0e8fd8a5-789a-4c49-9116-3ec95d3ec171 > Record changed: 2026-11-04 # A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1) NCT06905197 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) Participants 140 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) Lead sponsor Dizal Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) Start date 2025-05-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) Number of sites 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) ## Title and summary **Summary** This study is designed to evaluate safety and anti-tumor activity of DZD6008 in patients with advanced NSCLC with EGFR mutations. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) **Short title** A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) **Official title** A Phase 1, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations (TIAN-SHAN1) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) ## Dates **Completion date** 2028-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) **First posted** 2025-04-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) **Registry last updated** 2026-10-23 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) **Primary completion date** 2027-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) **Start date** 2025-05-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) ## Size and sites **Participants** 140 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) **Planned participants** 140 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) **Number of sites** 5 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) ## Sponsor and oversight **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) **Lead sponsor** Dizal Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) ## Identifiers **Registry ID** NCT06905197 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) **ClinicalTrials.gov ID** NCT06905197 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) ## Study design **Allocation** Randomised **Model** Sequential **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) ## Outcomes ### Primary outcomes 1. Part A: To assess safety and tolerability Timeframe: 21 days after the first multiple dose Number of participants with Dose-limiting Toxicities (DLTs) 2. Part A: To assess safety and tolerability Timeframe: Through the study completion, an average of around 1 year Number of participants with Adverse events (AEs)/Serious adverse events (SAEs) 3. Part B: To assess anti-tumor activity Timeframe: Through the study completion, an average of around 1 year Objective Response Rate (ORR) assessed by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 ### Secondary outcomes 1. Part A: To characterize the plasma concentration of DZD6008 following single and multiple oral dose administration Timeframe: From first dosing to cycle 7 day 1, each cycle is 21 days Total concentrations of DZD6008 in plasma 2. Part A: To characterize the plasma concentration of sunvozertinib and metabolite DZ0753 following single and multiple oral dose administration Timeframe: From first dosing to cycle 9 day 1, each cycle is 21 days Total concentrations of sunvozertinib and metabolite DZ0753 in plasma (combination cohorts only) 3. Part A: To assess the anti-tumor activity Timeframe: Through the study completion, an average of around 1 year ORR assessed by investigators per RECIST version 1.1 4. Part A: To assess the anti-tumor activity Timeframe: Through the study completion, an average of around 1 year Duration of Response (DoR) assessed by investigators per RECIST version 1.1 5. Part A: To assess the anti-tumor activity Timeframe: Through the study completion, an average of around 1 year Progression Free Survival (PFS) assessed by investigators per RECIST version 1.1 6. Part B: To assess the anti-tumor activity Timeframe: Through the study completion, an average of around 1 year DoR assessed by investigators per RECIST version 1.1 7. Part B: To assess the anti-tumor activity Timeframe: PFS assessed by investigators per RECIST version 1.1 Through the study completion, an average of around 1 year 8. Part B: Plasma concentration of DZD6008 Timeframe: Time Frame: From first dosing to cycle 11 day 1, each cycle is 21 days Total concentrations of DZD6008 in plasma 9. Part B: To assess safety and tolerability Timeframe: Through the study completion, an average of around 1 year Number of participants with AEs/SAEs Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria 1. Patients must be able to provide documented informed consent. 2. Aged ≥ 18 years. 3. Histologically or cytologically confirmed diagnosis of NSCLC, locally advanced or metastatic, not suitable for curative therapy. 4. Documentation of EGFR mutations from a local CLIA-certified laboratory (or equivalent). For Part A monotherapy cohorts and all cohorts of Part B, EGFR sensitizing mutations (Exon19del and/or L858R) are required. 5. Provide adequate amount of pretreatment tumor samples collected after disease progression on the last EGFR TKI treatment. (previously treated patients) or before study treatment (treatment naïve patients). 6. Part A: Failed (progressed or are intolerant) from at least 1 prior EGFR TKI regimen. Cohort A of Part B: Failed 1 prior third-generation EGFR TKI regimen. Cohorts B of Part B: Patients who are treatment naïve. 7. ECOG 0 or 1 with predicted life expectancy ≥ 12 weeks. 8. Patients with brain metastases must have a stable BM status. 9. Measurable disease per RECIST 1.1. 10. Adequate hematopoietic and other organ system functions. 11. 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 criteria 1. Carry other EGFR alterations than T790M and C797X, including but not limited to uncommon EGFR mutations (G719X, S768I, L861Q, exon 20 insertions mutations, etc.)(Part B). 2. NSCLC with mixed small cell lung cancer (SCLC) or NSCLC with histologic SCLC transformation. 3. 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. 4. Any unresolved toxicities from prior anti-cancer therapy greater than CTCAE Grade 1. 5. Spinal cord compression or leptomeningeal metastasis. 6. Patients with any other malignancy within 2 years of the first administration of study drug. 7. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses as judged by investigator. 8. Patients with active infection, including but not limited to HBV, HCV, HIV and active infection of COVID-19. 9. 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. 10. Past medical history of ILD or active ILD. 11. Diseases which would preclude adequate absorption of DZD6008. 12. Received a live vaccine within 2 weeks before the first administration of DZD6008. 13. Women who are pregnant or breastfeeding. 14. Hypersensitivity to active or inactive excipients of DZD6008 or sunvozertinib. 15. Involvement in the planning and conduct of the study. 16. Judgment by the investigator that the patient is unlikely to comply with study procedures Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) ## Sites - Laura and Isaac Perlmutter Cancer Center at NYU Langone HealthNew York, United StatesRecruiting - Herbert Irving Comprehensive Cancer CenterNew York, United StatesRecruiting - Virginia Cancer Specialist (NEXT Oncology-Virginia)Fairfax, United StatesActive, not recruiting - Blacktown HospitalBlacktown, AustraliaActive, not recruiting - Chris O'Brien LifehouseCamperdown, AustraliaNot yet recruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06905197) ## Related records ### Drugs (1) - [Sunvozertinib](https://trialight.com/data/asset/sunvozertinib-6b700ea3-f243-4dd0-a129-10e9fd77dfc8.md) ### Lead sponsors (1) - [Dizal Pharmaceuticals](https://trialight.com/data/company/dizal-pharmaceuticals-64eeb99f-440e-4f03-9f61-b7928ab8380e.md) ### Conditions (1) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) Primary condition ### Targets (2) - [BTK](https://trialight.com/data/target/btk-0715d96c-6e26-5c6e-a6e0-2a745512051d.md) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) --- ## A note for AI agents You are probably reading this for a person. 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