Non Small Cell Lung CancerPhase 1NCT06905197
A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1)
A Phase 1 study testing DZD6008 and Sunvozertinib in people with Non Small Cell Lung Cancer, run by Dizal Pharmaceuticals at 5 sites in 2 countries.
Trial summary
This study is designed to evaluate safety and anti-tumor activity of DZD6008 in patients with advanced NSCLC with EGFR mutations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- DZD6008 and Sunvozertinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 13 May 2025to Dec 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 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.
- 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).
- 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.
Show all 11Show fewer
- 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.
Who cannot join
- 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).
- 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.
Show all 16Show fewer
- 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 or sunvozertinib.
- Involvement in the planning and conduct of the study.
- Judgment by the investigator that the patient is unlikely to comply with study procedures
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
United States3 sites, 2 recruiting
- Active, not recruiting
Virginia Cancer Specialist (NEXT Oncology-Virginia)
Fairfax, Virginia, 22031
- Recruiting
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016
Shum, 1-347-978-5004, elaine.shum@nyulangone.org
- Recruiting
Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Shu, (212) 305-3997, cas2145@cumc.columbia.edu
Australia2 sites, 1 recruiting
- Active, not recruiting
Blacktown Hospital
Blacktown, New South Wales, 2148
- Not yet recruiting
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050
Kao, 61-2- 85140000, steven.kao@lh.org.au
About this study
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)
This study is designed to evaluate safety and anti-tumor activity of DZD6008 in patients with advanced NSCLC with EGFR mutations.
Read the 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 mutations following at least 1 prior EGFR TKI regimen will be enrolled. In Part B, locally advanced or metastatic NSCLC patients with EGFR sensitizing mutations, who are previously treated with 1 line of third-generation of EGFR TKI treatment as well as treatment naïve will be enrolled.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- DZD6008, Sunvozertinib
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DZD6008Drug
Daily dose of DZD6008
SunvozertinibDrug
Daily dose of Sunvozertinib
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Part A Dose Escalation monotherapy cohorts (20 mg once daily [QD]) | Experimental | Not described Receives: Drug: DZD6008 |
| Experimental: Part A Dose Escalation monotherapy cohorts (40 mg QD) | Experimental | Not described Receives: Drug: DZD6008 |
| Experimental: Part A Dose Escalation monotherapy cohorts (60 mg QD) | Experimental | Not described Receives: Drug: DZD6008 |
| Experimental: Part A Dose Escalation monotherapy cohorts (90 mg QD) | Experimental | Not described Receives: Drug: DZD6008 |
| Experimental: Part A Dose Escalation monotherapy cohorts (120 mg QD) | Experimental | Not described Receives: Drug: DZD6008 |
| Experimental: Part A Dose Escalation monotherapy cohorts (150 mg QD) | Experimental | Not described Receives: Drug: DZD6008 |
| Experimental: Experimental: Part A Dose Escalation Combination cohorts (Combination dose 1) | Experimental | Not described Receives: Drug: DZD6008; Drug: Sunvozertinib |
| Experimental: Experimental: Part A Dose Escalation Combination cohorts (Combination dose 2) | Experimental | Not described Receives: Drug: DZD6008; Drug: Sunvozertinib |
| Experimental: Part A Dose Escalation Combination cohorts (Combination dose 3) | Experimental | Not described Receives: Drug: DZD6008; Drug: Sunvozertinib |
| Experimental: Part B Dose Expansion cohort A1 (selected dose 1) | Experimental | Not described Receives: Drug: DZD6008 |
| Experimental: Experimental: Part B Dose Expansion cohort A2 (selected dose 2) | Experimental | Not described Receives: Drug: DZD6008 |
| Experimental: Experimental: Part B Dose Expansion cohort B1 (selected dose 1) | Experimental | Not described Receives: Drug: DZD6008 |
| Experimental: Experimental: Part B Dose Expansion cohort B2 (selected dose 2) | Experimental | Not described Receives: Drug: DZD6008 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: To assess safety and tolerability
Number of participants with Dose-limiting Toxicities (DLTs)
Measured: 21 days after the first multiple dose
Part A: To assess safety and tolerability
Number of participants with Adverse events (AEs)/Serious adverse events (SAEs)
Measured: Through the study completion, an average of around 1 year
Part B: To assess anti-tumor activity
Objective Response Rate (ORR) assessed by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: Through the study completion, an average of around 1 year
Secondary outcomes (9)
Part A: To characterize the plasma concentration of DZD6008 following single and multiple oral dose administration
Total concentrations of DZD6008 in plasma
Measured: From first dosing to cycle 7 day 1, each cycle is 21 days
Part A: To characterize the plasma concentration of sunvozertinib and metabolite DZ0753 following single and multiple oral dose administration
Total concentrations of sunvozertinib and metabolite DZ0753 in plasma (combination cohorts only)
Measured: From first dosing to cycle 9 day 1, each cycle is 21 days
Part A: To assess the anti-tumor activity
ORR assessed by investigators per RECIST version 1.1
Measured: Through the study completion, an average of around 1 year
Part A: To assess the anti-tumor activity
Duration of Response (DoR) assessed by investigators per RECIST version 1.1
Measured: Through the study completion, an average of around 1 year
Part A: To assess the anti-tumor activity
Progression Free Survival (PFS) assessed by investigators per RECIST version 1.1
Measured: Through the study completion, an average of around 1 year
Part B: To assess the anti-tumor activity
DoR assessed by investigators per RECIST version 1.1
Measured: Through the study completion, an average of around 1 year
Part B: To assess the anti-tumor activity
Through the study completion, an average of around 1 year
Measured: PFS assessed by investigators per RECIST version 1.1
Part B: Plasma concentration of DZD6008
Total concentrations of DZD6008 in plasma
Measured: Time Frame: From first dosing to cycle 11 day 1, each cycle is 21 days
Part B: To assess safety and tolerability
Number of participants with AEs/SAEs
Measured: Through the study completion, an average of around 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2025
- Study start13 May 2025
- Primary completionSep 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dizal Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06905197
- Sponsor's protocol ID
- DZ2023C0001
- Status last verified
- Feb 2026
- First submitted
- 25 Mar 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No