Nonsmall-cell Lung CancerPhase 1NCT06813365
Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN2)
A Phase 1 study testing DZD6008 in people with Nonsmall-cell Lung Cancer, run by Dizal Pharmaceuticals at 1 site in China.
Trial summary
This study is designed to evaluate safety and antitumor activity of DZD6008 in patients with advanced NSCLC with EGFR mutations. This is the first time the drug is tested in human. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nonsmall-cell Lung Cancer
- What is being tested?
- DZD6008
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 12 Jun 2024to 30 Dec 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 sensitizing mutation (Exon19del and/or L858R) from a local CLIA-certified laboratory (or equivalent).
- Provide adequate amount of pretreatment tumor samples for retrospective confirmation of EGFR mutations by the central laboratory.
- Part A: Failed (progressed or are intolerant) at least 1 prior EGFR TKI and platinum-based chemotherapy. Part B: Cohorts 1, 2,5 and 6: Failed 1 prior third-generation EGFR TKI. Cohorts 3 and 4: Patients who are treatment naïve.
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- Note: Patients enrolled in the study should be representative of the population to meet the need for efficacy analysis in the population after TKI failure (e.g., including appropriate proportion and number of patients with the C797X mutation if possible)
- 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 any other known EGFR alterations, including but not limited to uncommon EGFR mutations (G719X, S768I, L861Q, exon 20 insertions, etc.), or other driver gene alterations with SOC treatments (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.
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- 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.
- 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 patients is unlikely to comply with study procedures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005
Wang Dr, 86-10-69155039, mengzhaowang@sina.com
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 Mutation (TIAN-SHAN2)
This study is designed to evaluate safety and antitumor activity of DZD6008 in patients with advanced NSCLC with EGFR mutations. This is the first time the drug is tested in human.
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 sensitizing mutations (Exon19del and/or L858R) following at least 1 prior EGFR TKI and platinum-based chemotherapy will be enrolled. In Part B, locally advanced or metastatic NSCLC patients with EGFR sensitizing mutations following 1 prior third-generation EGFR TKI and who are treatment naïve will be enrolled.
- Conditions
- Nonsmall-cell Lung Cancer
- Being tested
- DZD6008
- Keywords
- Lung Cancer, EGFR mutation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DZD6008Drug
Daily dose of DZD6008
| Study group | Role | What they receive |
|---|---|---|
| Part A Dose Escalation cohorts (20 mg once daily [QD]) | Experimental | Not described Receives: Drug: DZD6008 |
| Part A Dose Escalation cohorts (40 mg QD) | Experimental | Not described Receives: Drug: DZD6008 |
| Part A Dose Escalation cohorts (60 mg QD) | Experimental | Not described Receives: Drug: DZD6008 |
| Part A Dose Escalation cohorts (90 mg QD) | Experimental | Not described Receives: Drug: DZD6008 |
| Part A Dose Escalation cohorts (120 mg QD) | Experimental | Not described Receives: Drug: DZD6008 |
| Part A Dose Escalation cohorts (150 mg QD) | Experimental | Not described Receives: Drug: DZD6008 |
| Part B Dose Expansion cohorts (selected dose 1 QD) | Experimental | Not described Receives: Drug: DZD6008 |
| Part B Dose Expansion cohorts (selected dose 2 QD) | Experimental | Not described Receives: Drug: DZD6008 |
| Food effect cohort (selected dose 1) | Experimental | Not described Receives: Drug: DZD6008 |
| Food effect cohort (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) as 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 (12)
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 assess the urine concentration of DZD6008
Total concentrations of DZD6008 in urine.
Measured: At the first day of cycle 2 (each cycle is 21 days).
Part A: To assess cerebrospinal fluid of DZD6008 in participants with brain metastasis at baseline
Total concentrations of DZD6008 in cerebrospinal fluid
Measured: Cycle 1 day 15.
Part A: To assess the effect of low-fat food on the plasma concentration of DZD6008
Total concentrations of DZD6008 in plasma.
Measured: The first dosing day on cycle 0 (cycle 0 is 3 days).
Part A: To assess the anti-tumor activity
ORR as 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) as 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) as 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
Progression ORR as assessed by Independent Review Committee (IRC) per RECIST version 1.1.
Measured: Through the study completion, an average of around 1 year.
Part B: To assess the anti-tumor activity
Progression DoR as assessed by IRC and investigators per RECIST version 1.1.
Measured: Through the study completion, an average of around 1 year.
Part B: To assess the preliminary anti-tumor activity
Progression PFS as assessed by IRC and investigators per RECIST version 1.1.
Measured: Through the study completion, an average of around 1 year.
Part B: Plasma concentration of DZD6008
Total concentrations of DZD6008 in plasma.
Measured: From first dosing to cycle 11 day 1, each cycle is 21 days.
Part B: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start12 Jun 2024
- Primary completion30 Oct 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nonsmall-cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Dizal PharmaceuticalsThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 300 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
- NCT06813365
- Sponsor's protocol ID
- DZ2023C0002
- Status last verified
- Dec 2025
- First submitted
- 23 Dec 2024
- Last updated
- 28 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 Mutation (TIAN-SHAN2)
- ClinicalTrials.gov ID
- NCT06813365
- Acronym / sponsor ID
- DZ2023C0002
- Conditions
- Nonsmall-cell Lung Cancer
- Keywords
- Lung Cancer, EGFR mutation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Dizal PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to evaluate safety and antitumor activity of DZD6008 in patients with advanced NSCLC with EGFR mutations. This is the first time the drug is tested in human.
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) following at least 1 prior EGFR TKI and platinum-based chemotherapy will be enrolled. In Part B, locally advanced or metastatic NSCLC patients with EGFR sensitizing mutations following 1 prior third-generation EGFR TKI and who are treatment naïve will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Part A Dose Escalation cohorts (20 mg once daily [QD]) | Experimental | Drug: DZD6008 |
| Part A Dose Escalation cohorts (40 mg QD) | Experimental | Drug: DZD6008 |
| Part A Dose Escalation cohorts (60 mg QD) | Experimental | Drug: DZD6008 |
| Part A Dose Escalation cohorts (90 mg QD) | Experimental | Drug: DZD6008 |
| Part A Dose Escalation cohorts (120 mg QD) | Experimental | Drug: DZD6008 |
| Part A Dose Escalation cohorts (150 mg QD) | Experimental | Drug: DZD6008 |
| Part B Dose Expansion cohorts (selected dose 1 QD) | Experimental | Drug: DZD6008 |
| Part B Dose Expansion cohorts (selected dose 2 QD) | Experimental | Drug: DZD6008 |
| Food effect cohort (selected dose 1) | Experimental | Drug: DZD6008 |
| Food effect cohort (selected dose 2) | Experimental | Drug: DZD6008 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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 mutation (Exon19del and/or L858R) from a local CLIA-certified laboratory (or equivalent).
- Provide adequate amount of pretreatment tumor samples for retrospective confirmation of EGFR mutations by the central laboratory.
Key exclusion criteria (15 listed)
- Carry any other known EGFR alterations, including but not limited to uncommon EGFR mutations (G719X, S768I, L861Q, exon 20 insertions, etc.), or other driver gene alterations with SOC treatments (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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DZD6008Daily dose of DZD6008 | Drug | Food effect cohort (selected dose 1), Food effect cohort (selected dose 2), Part A Dose Escalation cohorts (120 mg QD), Part A Dose Escalation cohorts (150 mg QD), Part A Dose Escalation cohorts (20 mg once daily [QD]), Part A Dose Escalation cohorts (40 mg QD), Part A Dose Escalation cohorts (60 mg QD), Part A Dose Escalation cohorts (90 mg QD), Part B Dose Expansion cohorts (selected dose 1 QD), Part B Dose Expansion cohorts (selected dose 2 QD) |
Primary outcome
Part A: To assess safety and tolerability
Time frame: 21 days after the first multiple dose.
Number of participants with Dose-limiting Toxicities (DLTs)
Part A: To assess safety and tolerability
Time frame: Through the study completion, an average of around 1 year.
Number of participants with Adverse events (AEs)/Serious adverse events (SAEs)
Part B: To assess anti-tumor activity
Time frame: Through the study completion, an average of around 1 year.
Objective Response Rate (ORR) as assessed by investigators per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
12 secondary outcomes
Part A: To characterize the plasma concentration of DZD6008 following single and multiple oral dose administration
Time frame: From first dosing to cycle 7 day 1, each cycle is 21 days.
Part A: To assess the urine concentration of DZD6008
Time frame: At the first day of cycle 2 (each cycle is 21 days).
Part A: To assess cerebrospinal fluid of DZD6008 in participants with brain metastasis at baseline
Time frame: Cycle 1 day 15.
Part A: To assess the effect of low-fat food on the plasma concentration of DZD6008
Time frame: The first dosing day on cycle 0 (cycle 0 is 3 days).
Part A: To assess the anti-tumor activity
Time frame: Through the study completion, an average of around 1 year.
Part A: To assess the anti-tumor activity
Time frame: Through the study completion, an average of around 1 year.
Part A: To assess the anti-tumor activity
Time frame: Through the study completion, an average of around 1 year.
Part B: To assess the anti-tumor activity
Time frame: Through the study completion, an average of around 1 year.
Part B: To assess the anti-tumor activity
Time frame: Through the study completion, an average of around 1 year.
Part B: To assess the preliminary anti-tumor activity
Time frame: Through the study completion, an average of around 1 year.
Part B: Plasma concentration of DZD6008
Time frame: From first dosing to cycle 11 day 1, each cycle is 21 days.
Part B: To assess safety and tolerability
Time frame: Through the study completion, an average of around 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DZD6008 in people with Nonsmall-cell Lung Cancer, run by Dizal Pharmaceuticals at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui Wang (86-21-61098347, Hui.Wang02@dizalpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A: To assess safety and tolerability (time frame: 21 days after the first multiple dose.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.