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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06905197




Registration number
NCT06905197
Ethics application status
Date submitted
25/03/2025
Date registered
1/04/2025
Date last updated
5/09/2025

Titles & IDs
Public title
A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1)
Scientific 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)
Secondary ID [1] 0 0
DZ2023C0001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non Small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - DZD6008

Experimental: Experimental: Part A Dose Escalation cohorts (20 mg once daily [QD]) -

Experimental: Experimental: Part A Dose Escalation cohorts (40 mg QD) -

Experimental: Experimental: Part A Dose Escalation cohorts (60 mg QD) -

Experimental: Experimental: Part A Dose Escalation cohorts (90 mg QD) -

Experimental: Experimental: Part A Dose Escalation cohorts (120 mg QD) -

Experimental: Experimental: Part A Dose Escalation cohorts (150 mg QD) -

Experimental: Experimental: Part B Dose Expansion cohorts (selected dose 1 QD) -

Experimental: Experimental: Part B Dose Expansion cohorts (selected dose 2 QD) -


Treatment: Drugs: DZD6008
Daily dose of DZD6008
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A: To assess safety and tolerability
Timepoint [1] 0 0
21 days after the first multiple dose
Primary outcome [2] 0 0
Part A: To assess safety and tolerability
Timepoint [2] 0 0
Through the study completion, an average of around 1 year
Primary outcome [3] 0 0
Part B: To assess anti-tumor activity
Timepoint [3] 0 0
Through the study completion, an average of around 1 year
Secondary outcome [1] 0 0
Part A: To characterize the plasma concentration of DZD6008 following single and multiple oral dose administration
Timepoint [1] 0 0
From first dosing to cycle 7 day 1, each cycle is 21 days
Secondary outcome [2] 0 0
Part A: To assess the anti-tumor activity
Timepoint [2] 0 0
Through the study completion, an average of around 1 year
Secondary outcome [3] 0 0
Part A: To assess the anti-tumor activity
Timepoint [3] 0 0
Through the study completion, an average of around 1 year
Secondary outcome [4] 0 0
Part A: To assess the anti-tumor activity
Timepoint [4] 0 0
Through the study completion, an average of around 1 year
Secondary outcome [5] 0 0
Part B: To assess the anti-tumor activity
Timepoint [5] 0 0
Through the study completion, an average of around 1 year
Secondary outcome [6] 0 0
Part B: To assess the anti-tumor activity
Timepoint [6] 0 0
Through the study completion, an average of around 1 year
Secondary outcome [7] 0 0
Part B: To assess the anti-tumor activity
Timepoint [7] 0 0
PFS assessed by IRC and investigators per RECIST version 1.1
Secondary outcome [8] 0 0
Part B: Plasma concentration of DZD6008
Timepoint [8] 0 0
Time Frame: From first dosing to cycle 11 day 1, each cycle is 21 days
Secondary outcome [9] 0 0
Part B: To assess safety and tolerability
Timepoint [9] 0 0
Through the study completion, an average of around 1 year

Eligibility
Key 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). Part A: EGFR sensitizing mutations (Exon19del and/or L858R). Part B: EGFR sensitizing mutations (Exon19del and/or L858R) and C797X mutation.
5. Provide adequate amount of pretreatment tumor samples collected after disease progression on the last EGFR TKI treatment.
6. Failed (progressed or are intolerant) from at least 1 prior EGFR TKI regimen.
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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Carry any other known EGFR alterations, including but not limited to uncommon EGFR mutations (G719X, S768I, L861Q, exon 20 insertions, 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.
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/05/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2028
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 0 0
Chris O'Brien Lifehouse - Camperdown
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2050 - Camperdown
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
Virginia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Dizal Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Yifan Liu
Address 0 0
Country 0 0
Phone 0 0
86-21-61095854
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06905197