Non-Small Cell Lung CancerPhase 1/2NCT07079475

Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8)

A Phase 1/2 study testing DZD6008, Sunvozertinib and Osimertinib in people with Non-Small Cell Lung Cancer, run by Dizal Pharmaceuticals at 14 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

This study will treat patients with advanced NSCLC harboring EGFR mutations. This is the first study to test DZD6008 combined with sunvozertinib in patients, which will help to understand what type of side effects with the treatment. 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, Sunvozertinib and Osimertinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 220 participants
Where: 14 sitesChina
Study dates: 30 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

Participants must be able to provide documented informed consent.
Aged ≥ 18 years.
Histologically or cytologically confirmed diagnosis of non-squamous NSCLC, locally advanced or metastatic, not suitable for curative therapy.
Documentation of EGFR mutation from a local certified laboratory. Part A: EGFR mutations (excluding participants only harboring EGFR exon20ins). Part B: EGFR sensitizing mutations (Exon19del and/or L858R) with or without T790M/C797S resistance mutations.
Provide adequate baseline tumor and plasma samples. For part A: tumor samples collected after disease progression on the last EGFR TKI treatment. For part B: tumor samples of B1 and B2 cohorts should be collected after disease progression on the last EGFR TKI treatment. Tumor samples of B3 cohort should be collected before the study treatment.
Previous anti-tumor therapy requirement. For part A, B1, and B2 cohorts of part B: participants should have failed (progressed on or are intolerant to) one line of third-generation EGFR TKI regimen (such as Osimertinib), with (cohort B2) or without (cohort B1) prior platinum-based chemotherapy treatment. Participants could receive no more than 2 lines of EGFR TKI treatment and no more than 3 lines of systemic therapy. Participants in B3 cohort: should not receive prior systemic anti-tumor therapy.

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ECOG 0 or 1 with predicted life expectancy ≥ 12 weeks.
Brain metastases must be stable at study entry.
Measurable disease per RECIST 1.1.
Adequate hematopoietic and other organ system functions.

Who cannot join

NSCLC with mixed small-cell lung cancer (SCLC) or NSCLC with histologic SCLC transformation.
For part A: participants only harboring EGFR exon20ins（harboring other EGFR mutations could be enrolled）.
Prior treatment with any of the following: 1) Previously received two or more than two lines of third-generation EGFR TKI treatment. 2) Previously received systemic anti-cancer therapy for advanced disease (only for B3 cohort). 3) Immunotherapy or other antibody therapy within 4 weeks prior to the first administration; 4) 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; 5) Radiotherapy with a limited field of radiation for palliation within 7 days of the first administration, radiation to more than 30% of the bone marrow or with a wide field of radiation within 28 days of the first administration; 6) 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; 7) Currently receiving or unable to stop drugs known to be CYP3A4 sensitive substrate with a narrow therapeutic index. A washout period of at least 2 weeks is required prior to the first study drug administration; 8) Currently receiving or unable to stop drugs known to be proton-pump inhibitors. A washout period of at least 1 week is required prior to the first study drug administration; 9) Major surgery within 4 weeks of the first administration of study drug administration 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.
Participants with any other malignancy within 2 years of the first administration of the study drug.

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Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses as judged by the investigator.
Participants with active infection, including but not limited to HBV, HCV and HIV.
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 that would preclude adequate absorption of study drug.
Received a live vaccine within 2 weeks before the first administration of study drug.
Women who are pregnant or breastfeeding.
Hypersensitivity to active or inactive excipients of DZD6008, sunvozertinib or osimertinib (only for B3 cohort).

Trial locations and contacts

14 sites in 1 country. Contact the study team or a site near you to ask about taking part.

YIFAN LIU contact

(86) 021-61095854

yifan.liu@dizalpharma.com

clinicaltrials@dizalpharma.com contact

clinicaltrials@dizalpharma.com

City, postcode or hospital

Sites recruiting now only

14 sites in 1 country

China14 sites, 14 recruiting

Beijing Chest Hospital
Beijing, Beijing Municipality, 101125
Prof. Lin, 86-13313786157, lingen@bjxkyy.cn
Recruiting
Hunan Cancer Hospital
Changsha, Hunan
Dr Zhang, 86-13873123436, zhanglei1152@126.com
Not yet recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan, 6100042
Prof. Zhou, 86-18908190355, zhoujt521@163.com
Recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan
Dr Li, 86-18980605143, 59968642@qq.com
Not yet recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Dr Zhou, 86-13560351186, doctorzcz@163.com
Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310005
Prof. Yu, 86-13705718617, yuxm@zjcc.org.cn
Recruiting
Harbin Cancer Hospital
Harbin, Heilongjiang
Dr Yu, 86-18980606909, gpyuyan@163.com
Not yet recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
Prof. Tang, 86-13708938661, cot163@163.com
Recruiting
Jiangsu People's Hospital
Nanjing, Jiangsu
Dr. Guo, 86-13585145540, guorenhua@csco.ac.cn
Not yet recruiting
Nanjing Gulou Hospital
Nanjing, Jiangsu
Dr Wang, 86-15150580136, dolphin8012@yahoo.com
Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Prof. Lu, 86-21-22200000 ext. 3123, shunlu_shchest@sina.com
Recruiting
First Affilicated Hospital of China Medical University
Shengyang, Liaoning
Dr Zhao, 86-13644055129, zhaomf618@126.com
Not yet recruiting
Zhejiang Taizhou Hospital
Taizhou, Zhejiang, 317000
Prof. Lv, 86-13867622009, lvdq@enzemed.com
Recruiting
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060
Prof. Huang, 86-18622221232, dingzhih72@163.com
Recruiting

Other trials in China

About this study

Official title: A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 Combined With Sunvozertinib in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations (TIAN-SHAN8)

Conditions: Non-Small Cell Lung Cancer
Being tested: DZD6008, Sunvozertinib, Osimertinib
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 will be administered orally at 40/60 mg QD or selected dose.
SunvozertinibDrug
Sunvozertinib will be administered orally at 100/200 mg QD or selected dose.
OsimertinibDrug
Osimertinib will be administered orally at 80 mg QD

Study groups in NCT07079475
Study group	Role	What they receive
DZD6008 + Sunvozertinib	Experimental	Not described Receives: Drug: DZD6008; Drug: Sunvozertinib
Osimertinib	Active comparator	Not described Receives: Drug: Osimertinib

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 Adverse events (AEs)/Serious adverse events (SAEs)
Measured: Through the study completion, an average of around 2 years
Part A: To assess safety and tolerability
Number of participants with Dose-limiting Toxicities (DLTs)
Measured: 21 days after the first dose
Part B: To assess anti-tumor activity
Objective Response Rate (ORR) assessed by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: Through the study completion, an average of around 2 years

Secondary outcomes (14)

Part A: To assess the anti-tumor activity
ORR assessed by investigator per RECIST version 1.1
Measured: Through the study completion, an average of around 2 years
Part A: To assess the anti-tumor activity
Duration of Response (DoR) assessed by investigator per RECIST version 1.1
Measured: Through the study completion, an average of around 2 years
Part A: To assess the anti-tumor activity
Disease Control Rate (DCR) assessed by investigator per RECIST version 1.1
Measured: Through the study completion, an average of around 2 years
Part A: To assess the anti-tumor activity
Percentage change in tumor size assessed by investigator per RECIST version 1.1
Measured: Through the study completion, an average of around 2 years
Part A: To assess the anti-tumor activity
Progression Free Survival (PFS) assessed by investigator per RECIST version 1.1
Measured: Through the study completion, an average of around 2 years
Part A: To characterize the Pharmacokinetics of DZD6008
To characterize the concentration of DZD6008 in plasma and cerebrospinal fluid (selected participants with brain metastasis).
Measured: Through the study until the time specified in the protocol, an average of around half year.
Part A: To characterize the Pharmacokinetics of sunvozertinib and DZ0753
To characterize the concentrations of sunvozertinib and DZ0753 in plasma and cerebrospinal fluid (selected participants with brain metastasis).
Measured: Through the study until the time specified in the protocol, an average of around half year.
Part B: To assess the anti-tumor activity
DoR assessed by investigator per RECIST version 1.1
Measured: Through the study completion, an average of around 2 years
Part B: To assess the anti-tumor activity
DCR assessed by investigator per RECIST version 1.1
Measured: Through the study completion, an average of around 2 years
Part B: To assess the anti-tumor activity
Percentage change in tumor size assessed by investigator per RECIST version 1.1
Measured: Through the study completion, an average of around 2 years
Part B: To assess the anti-tumor activity
PFS assessed by investigator per RECIST version 1.1
Measured: Through the study completion, an average of around 2 years
Part B: To assess safety and tolerability
Number of participants with AEs /SAEs
Measured: Through the study completion, an average of around 2 years
Part B: To characterize the Pharmacokinetics of DZD6008
To characterize the concentration of DZD6008 in plasma and cerebrospinal fluid (selected participants with brain metastasis).
Measured: Through the study until the time specified in the protocol, an average of around half year.
Part B: To characterize the Pharmacokinetics of sunvozertinib and DZ0753
To characterize the concentration of sunvozertinib and DZ0753 in plasma and cerebrospinal fluid (selected participants with brain metastasis).
Measured: Through the study until the time specified in the protocol, an average of around half year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jul 2025Dec 2028

First posted23 Jul 2025
Study start30 Jul 2025
Primary completionJun 2028 (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: Parallel groups
Masking: None (open label)
Enrolment: 220 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07079475
Sponsor's protocol ID: DZ2025C0001
Status last verified: May 2026
First submitted: 10 Jul 2025
Last updated: 23 Oct 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 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of DZD6008 Combined With Sunvozertinib in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) With EGFR Mutations (TIAN-SHAN8)
ClinicalTrials.gov ID: NCT07079475
Acronym / sponsor ID: DZ2025C0001
Conditions: Non-Small Cell Lung Cancer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 220 participants (estimated)
Lead sponsor: Dizal PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 30 Jul 2025 (actual)
Primary completion: Jun 2028 (estimated)
Study completion: Dec 2028 (estimated)
First posted: 23 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
DZD6008 + Sunvozertinib	Experimental	Drug: DZD6008, Drug: Sunvozertinib
Osimertinib	Active comparator	Drug: Osimertinib

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Participants must be able to provide documented informed consent.
Aged ≥ 18 years.
Histologically or cytologically confirmed diagnosis of non-squamous NSCLC, locally advanced or metastatic, not suitable for curative therapy.
Documentation of EGFR mutation from a local certified laboratory. Part A: EGFR mutations (excluding participants only harboring EGFR exon20ins). Part B: EGFR sensitizing mutations (Exon19del and/or L858R) with or without T790M/C797S resistance mutations.
Provide adequate baseline tumor and plasma samples. For part A: tumor samples collected after disease progression on the last EGFR TKI treatment. For part B: tumor samples of B1 and B2 cohorts should be collected after disease progression on the last EGFR TKI treatment. Tumor samples of B3 cohort should be collected before the study treatment.

Key exclusion criteria (14 listed)

NSCLC with mixed small-cell lung cancer (SCLC) or NSCLC with histologic SCLC transformation.
For part A: participants only harboring EGFR exon20ins（harboring other EGFR mutations could be enrolled）.
Prior treatment with any of the following: 1) Previously received two or more than two lines of third-generation EGFR TKI treatment. 2) Previously received systemic anti-cancer therapy for advanced disease (only for B3 cohort). 3) Immunotherapy or other antibody therapy within 4 weeks prior to the first administration; 4) 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; 5) Radiotherapy with a limited field of radiation for palliation within 7 days of the first administration, radiation to more than 30% of the bone marrow or with a wide field of radiation within 28 days of the first administration; 6) 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; 7) Currently receiving or unable to stop drugs known to be CYP3A4 sensitive substrate with a narrow therapeutic index. A washout period of at least 2 weeks is required prior to the first study drug administration; 8) Currently receiving or unable to stop drugs known to be proton-pump inhibitors. A washout period of at least 1 week is required prior to the first study drug administration; 9) Major surgery within 4 weeks of the first administration of study drug administration 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
DZD6008DZD6008 will be administered orally at 40/60 mg QD or selected dose.	Drug	DZD6008 + Sunvozertinib
SunvozertinibSunvozertinib will be administered orally at 100/200 mg QD or selected dose.	Drug	DZD6008 + Sunvozertinib
OsimertinibOsimertinib will be administered orally at 80 mg QD	Drug	Osimertinib

Primary outcome

Part A: To assess safety and tolerability
Time frame: Through the study completion, an average of around 2 years
Number of participants with Adverse events (AEs)/Serious adverse events (SAEs)
Part A: To assess safety and tolerability
Time frame: 21 days after the first dose
Number of participants with Dose-limiting Toxicities (DLTs)
Part B: To assess anti-tumor activity
Time frame: Through the study completion, an average of around 2 years
Objective Response Rate (ORR) assessed by investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

14 secondary outcomes

Part A: To assess the anti-tumor activity
Time frame: Through the study completion, an average of around 2 years
Part A: To assess the anti-tumor activity
Time frame: Through the study completion, an average of around 2 years
Part A: To assess the anti-tumor activity
Time frame: Through the study completion, an average of around 2 years
Part A: To assess the anti-tumor activity
Time frame: Through the study completion, an average of around 2 years
Part A: To assess the anti-tumor activity
Time frame: Through the study completion, an average of around 2 years
Part A: To characterize the Pharmacokinetics of DZD6008
Time frame: Through the study until the time specified in the protocol, an average of around half year.
Part A: To characterize the Pharmacokinetics of sunvozertinib and DZ0753
Time frame: Through the study until the time specified in the protocol, an average of around half year.
Part B: To assess the anti-tumor activity
Time frame: Through the study completion, an average of around 2 years
Part B: To assess the anti-tumor activity
Time frame: Through the study completion, an average of around 2 years
Part B: To assess the anti-tumor activity
Time frame: Through the study completion, an average of around 2 years
Part B: To assess the anti-tumor activity
Time frame: Through the study completion, an average of around 2 years
Part B: To assess safety and tolerability
Time frame: Through the study completion, an average of around 2 years
Part B: To characterize the Pharmacokinetics of DZD6008
Time frame: Through the study until the time specified in the protocol, an average of around half year.
Part B: To characterize the Pharmacokinetics of sunvozertinib and DZ0753
Time frame: Through the study until the time specified in the protocol, an average of around half 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 23 Oct 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.

YIFAN LIU contact

(86) 021-61095854

yifan.liu@dizalpharma.com

clinicaltrials@dizalpharma.com contact

clinicaltrials@dizalpharma.com

14 sites 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, Sunvozertinib and Osimertinib in people with Non-Small Cell Lung Cancer, run by Dizal Pharmaceuticals at 14 sites 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 14 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 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites 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 YIFAN LIU ((86) 021-61095854, yifan.liu@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: Through the study completion, an average of around 2 years). 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?

On the ClinicalTrials.gov record for NCT07079475.

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 23 Oct 2026.