Non Small Cell Lung CancerPhase 1/2NCT07070440
DZD6008 Combination Therapy in Patients With Locally Advanced or Metastatic NSCLC With EGFR Mutation (TIAN-SHAN7)
A Phase 1/2 study testing DZD6008, Pemetrexed and Carboplatin in people with Non Small 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 combination therapy in patients with advanced Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (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, Pemetrexed and Carboplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2025to Dec 2028
- Phase
- Phase 1/2
- 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
- Signed informed consent.
- Age ≥18 years old.
- Locally advanced or metastatic non-squamous non-small cell lung cancer by histopathology or cytology, not suitable for other radical treatment.
- Documentation of EGFR sensitizing mutation confirmed by local laboratory.
- Provide sufficient tumor tissue samples and plasma samples for retrospective analysis of EGFR mutations by central laboratory.
- Failure of prior 3 generations EGFR TKI or treatment naive.
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- ECOG status score 0-1, life expectancy ≥12 weeks.
- No central nervous system symptoms during screening, no need for corticosteroids or dehydration diuretic treatment for at least 4 weeks before the first dosing. If the patient with brain metastasis has received radiotherapy or surgery, there is a washout period of ≥2 weeks before the first use of DZD6008 and ensure that the AE related to radiotherapy or surgery has recovered to ≤ 1 grade.
- Presence of measurable lesions defined by RECIST 1.1.
- Sufficient bone marrow or other organ reserve before first dosing.
Who cannot join
- Histology mixed with small cell lung cancer (SCLC) or with SCLC transformation.
- Received the following treatments or had the following lifestyle habits, etc.:
- Received immunotherapy or other antibody treatments (including EGFR-targeted antibodies, bispecific antibodies or antibody-drug conjugates, etc.) within 4 weeks before the first study drug administration.
- Received any cytotoxic chemotherapy, study drugs or other anti-cancer drugs (excluding macromolecule drugs) within 14 days before the first study drug administration.
- Received limited-range radiotherapy to relieve the disease within 7 days before the first study drug administration, or received more than 30% of the bone marrow radiotherapy or received wide-range radiotherapy within 28 days before the first medication.
- 2 weeks (for CYP3A4 inhibitors) or 3 weeks (for CYP3A4 inducers) before the first study drug administration, are taking or cannot stop taking known cytochrome P450 (CYP) 3A4 strong inhibitors or inducers (including herbal supplements, such as St. John's wort).
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- 2 weeks before the first study drug administration, are taking or cannot stop taking known CYP3A4 sensitive substrate drugs (with a narrow therapeutic window).
- Taking or being unable to stop taking drugs known to be proton pump inhibitors within 1 week before the first study drug administration.
- Major invasive surgery has been performed within 4 weeks before the first study drug administration or is planned during treatment.
- Presence of AEs of >1 grade (except any degree of alopecia) caused by previous treatment (such as adjuvant chemotherapy, radiotherapy).
- Tumor-related spinal cord compression or meningeal metastasis.
- History of malignant tumor within 2 years (except for basal cell carcinoma of the skin or cervical cancer in situ that has been adequately treated; other tumors that have been tumor-free for more than 2 years and are expected to survive for more than 2 years, which needs to be discussed with Dizal clinical research physicians).
- Presence of severe or uncontrollable systemic diseases, including poorly controlled hypertension, bleeding diseases.
- Presence of persistent or active infections, including but not limited to hepatitis B, hepatitis C and human immunodeficiency virus infection (HIV).
- Any of the following heart-related diseases or abnormalities:
- QT interval (QTc) >470 msec after calibration of 12-lead ECG at rest during the screening period.
- Any serious abnormalities of heart rate, conduction or pattern shown on the ECG at rest, such as complete left bundle branch block, third degree heart block, second degree heart block, PR interval >250 msec.
- Any disease or condition that can cause QTcF prolongation or arrhythmia, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or family members with a history of sudden death under the age of 40.
- Severe cardiovascular diseases such as myocardial infarction, unstable angina or congestive heart failure, cerebrovascular accident (such as history of stroke or intracranial hemorrhage) within 6 months before the first dose.
- History of deep vein thrombosis or pulmonary embolism within 4 weeks before the first dose (excluding non-obstructive catheter-related thrombosis).
- Patient history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid hormone treatment, or any clinically active ILD, immunotherapy-related pneumonitis.
- Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing medication, or previous intestinal resection that prevents adequate absorption of study medication.
- Live vaccine within 4 weeks before the first dose.
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
Shanghai Chest Hospital
Shanghai, Shanghai Municipality
Lu, 021-22200000 ext. 3123, Shun_lu@hotmail.com
About this study
Official title: A Phase 1/2, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 Combination Therapy in Patients With Locally Advanced or Metastatic NSCLC With EGFR Mutation (TIAN-SHAN7)
This study is designed to evaluate safety and antitumor activity of DZD6008 combination therapy in patients with advanced Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutations.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- DZD6008, Pemetrexed, Carboplatin, Docetaxel
- 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
DZD6008 was administered orally at 40/60/90 mg QD.
PemetrexedDrug
Pemetrexed 500 mg/m2, every 3 weeks, intravenous infusion.
CarboplatinDrug
Carboplatin AUC 5 mg/mL/min, every 3 weeks, intravenous infusion.
DocetaxelDrug
Docetaxel 75 mg/m2, every 3 weeks, intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| DZD6008+pemetrexed/carboplatin | Experimental | DZD6008 was administered at 40/60/90 mg Once Daily (QD). Pemetrexed 500 mg/m2, once every 3 weeks, intravenous infusion. Carboplatin AUC 5 mg/mL/min, once every 3 weeks, intravenous infusion Receives: Drug: DZD6008; Drug: Pemetrexed; Drug: Carboplatin |
| DZD6008+docetaxel | Experimental | DZD6008 was administered at 40/60/90 mg QD. Docetaxel 75 mg/m2, once every 3 weeks, intravenous infusion Receives: Drug: DZD6008; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Dose-limiting Toxicities (DLTs)
To assess safety and tolerability
Measured: 21 days after the first dosing
Number of participants with Adverse events (AEs)/Serious adverse events (SAEs)
To assess safety and tolerability
Measured: Through the study completion, an average of around 1 year.
Objective Response Rate (ORR) as assessed by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
To assess anti-tumor activity
Measured: Through the study completion, an average of around 1 year.
Secondary outcomes (7)
Duration of Response(DoR)
DoR is defined as the time from the date of the first documented response (subsequently confirmed) according to RECIST 1.1 to the date of objective disease progression or death, whichever occurred first.
Measured: Through the study completion, an average of around 1 year.]
Disease Control Rate (DCR)
DCR is defined as the proportion of subjects with response defined as complete response, partial response, and stable disease according to RECIST 1.1 by the investigator.
Measured: Through the study completion, an average of around 1 year.
Progression Free survival (PFS)
PFS is defined as the time from the first dose of the subject to objective disease progression based on RECIST 1.1 or death due to any cause (whichever occurs first).
Measured: Through the study completion, an average of around 1 year.
Maximum Plasma Concentration (Cmax) of DZD6008
Cmax = Maximum concentration
Measured: Plasma samples were collected at cycle 1, 2, 3, 5, 7, and 9, or cycle 1, 3, 5 and subsequent odd number cycles (cycle number adaptive to be consistent with tumor assessment), each cycle is 21 days
Area Under the Plasma Concentration-time Curve from Zero to the Last Measurable Concentration (AUC0-t) of DZD6008
AUC0-t= Area Under the Plasma Concentration-time Curve from Zero to the Last Measurable Concentration
Measured: Plasma samples were collected at cycle 1, 2, 3, 5, 7, and 9, or cycle 1, 3, 5 and subsequent odd number cycles (cycle number adaptive to be consistent with tumor assessment), each cycle is 21 days
Maximum Plasma Concentration (Cmax) of docetaxel
Cmax = Maximum concentration
Measured: Plasma samples were collected on at cycle 1 and 2, each cycle is 21 days
Area Under the Plasma Concentration-time Curve from Zero to the Last Measurable Concentration (AUC0-t)of docetaxel
AUC0-t = Area Under the Plasma Concentration-time Curve from Zero to the Last Measurable Concentration
Measured: Plasma samples were collected at cycles 1 and 2, each cycle is 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start16 Jul 2025
- Primary completionJun 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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dizal Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lu, Principal investigator, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07070440
- Sponsor's protocol ID
- DZ2024C0001
- Status last verified
- Aug 2026
- First submitted
- 16 Jun 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 Combination Therapy in Patients With Locally Advanced or Metastatic NSCLC With EGFR Mutation (TIAN-SHAN7)
- ClinicalTrials.gov ID
- NCT07070440
- Acronym / sponsor ID
- DZ2024C0001
- Conditions
- Non Small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Dizal PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 17 Jul 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 combination therapy in patients with advanced Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) mutations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DZD6008+pemetrexed/carboplatin | Experimental | Drug: DZD6008, Drug: Pemetrexed, Drug: CarboplatinDZD6008 was administered at 40/60/90 mg Once Daily (QD). Pemetrexed 500 mg/m2, once every 3 weeks, intravenous infusion. Carboplatin AUC 5 mg/mL/min, once every 3 weeks, intravenous infusion |
| DZD6008+docetaxel | Experimental | Drug: DZD6008, Drug: DocetaxelDZD6008 was administered at 40/60/90 mg QD. Docetaxel 75 mg/m2, once every 3 weeks, intravenous infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent.
- Age ≥18 years old.
- Locally advanced or metastatic non-squamous non-small cell lung cancer by histopathology or cytology, not suitable for other radical treatment.
- Documentation of EGFR sensitizing mutation confirmed by local laboratory.
- Provide sufficient tumor tissue samples and plasma samples for retrospective analysis of EGFR mutations by central laboratory.
Key exclusion criteria (23 listed)
- Histology mixed with small cell lung cancer (SCLC) or with SCLC transformation.
- Received the following treatments or had the following lifestyle habits, etc.:
- Presence of AEs of >1 grade (except any degree of alopecia) caused by previous treatment (such as adjuvant chemotherapy, radiotherapy).
- Tumor-related spinal cord compression or meningeal metastasis.
- History of malignant tumor within 2 years (except for basal cell carcinoma of the skin or cervical cancer in situ that has been adequately treated; other tumors that have been tumor-free for more than 2 years and are expected to survive for more than 2 years, which needs to be discussed with Dizal clinical research physicians).
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 |
|---|---|---|
| DZD6008DZD6008 was administered orally at 40/60/90 mg QD. | Drug | DZD6008+docetaxel, DZD6008+pemetrexed/carboplatin |
| PemetrexedPemetrexed 500 mg/m2, every 3 weeks, intravenous infusion. | Drug | DZD6008+pemetrexed/carboplatin |
| CarboplatinCarboplatin AUC 5 mg/mL/min, every 3 weeks, intravenous infusion. | Drug | DZD6008+pemetrexed/carboplatin |
| DocetaxelDocetaxel 75 mg/m2, every 3 weeks, intravenous infusion. | Drug | DZD6008+docetaxel |
Primary outcome
Number of participants with Dose-limiting Toxicities (DLTs)
Time frame: 21 days after the first dosing
To assess safety and tolerability
Number of participants with Adverse events (AEs)/Serious adverse events (SAEs)
Time frame: Through the study completion, an average of around 1 year.
To assess safety and tolerability
Objective Response Rate (ORR) as assessed by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: Through the study completion, an average of around 1 year.
To assess anti-tumor activity
7 secondary outcomes
Duration of Response(DoR)
Time frame: Through the study completion, an average of around 1 year.]
Disease Control Rate (DCR)
Time frame: Through the study completion, an average of around 1 year.
Progression Free survival (PFS)
Time frame: Through the study completion, an average of around 1 year.
Maximum Plasma Concentration (Cmax) of DZD6008
Time frame: Plasma samples were collected at cycle 1, 2, 3, 5, 7, and 9, or cycle 1, 3, 5 and subsequent odd number cycles (cycle number adaptive to be consistent with tumor assessment), each cycle is 21 days
Area Under the Plasma Concentration-time Curve from Zero to the Last Measurable Concentration (AUC0-t) of DZD6008
Time frame: Plasma samples were collected at cycle 1, 2, 3, 5, 7, and 9, or cycle 1, 3, 5 and subsequent odd number cycles (cycle number adaptive to be consistent with tumor assessment), each cycle is 21 days
Maximum Plasma Concentration (Cmax) of docetaxel
Time frame: Plasma samples were collected on at cycle 1 and 2, each cycle is 21 days
Area Under the Plasma Concentration-time Curve from Zero to the Last Measurable Concentration (AUC0-t)of docetaxel
Time frame: Plasma samples were collected at cycles 1 and 2, each cycle is 21 days
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 31 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Lu principal investigator
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing DZD6008, Pemetrexed and Carboplatin in people with Non Small 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 10 inclusion and 23 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 31 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Yuanli Dong (+86 21 61095854, yuanli.dong@dizalpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Dose-limiting Toxicities (DLTs) (time frame: 21 days after the first dosing). 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 31 Aug 2026.