A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1)

NCT06905197
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
140
clinicaltrials.gov
Lead sponsor
Dizal Pharmaceuticals
clinicaltrials.gov
Start date
2025-05-13
clinicaltrials.gov
Number of sites
5
clinicaltrials.gov

Summary
This study is designed to evaluate safety and anti-tumor activity of DZD6008 in patients with advanced NSCLC with EGFR mutations.
clinicaltrials.gov
Short title
A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1)
clinicaltrials.gov
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)
clinicaltrials.gov

Control arm
Open label
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2028-12-01
clinicaltrials.gov
First posted
2025-04-01
clinicaltrials.gov
Registry last updated
2026-10-23
clinicaltrials.gov
Primary completion date
2027-09-01
clinicaltrials.gov
Start date
2025-05-13
clinicaltrials.gov

Participants
140
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
140
clinicaltrials.gov
Protocol amendments
3
clinicaltrials.gov
Number of sites
5
clinicaltrials.gov

Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Dizal Pharmaceuticals
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT06905197
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06905197
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  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

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  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.

  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
clinicaltrials.gov

  • 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
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (2)