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.
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
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.
clinicaltrials@dizalpharma.com contact
14 sites in 1 country
China14 sites, 14 recruiting
- Recruiting
Beijing Chest Hospital
Beijing, Beijing Municipality, 101125
Prof. Lin, 86-13313786157, lingen@bjxkyy.cn
- Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan
Dr Zhang, 86-13873123436, zhanglei1152@126.com
- Recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan, 6100042
Prof. Zhou, 86-18908190355, zhoujt521@163.com
- Not yet recruiting
West China Hospital, Sichuan University
Chengdu, Sichuan
Dr Li, 86-18980605143, 59968642@qq.com
- 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
- Not yet recruiting
Harbin Cancer Hospital
Harbin, Heilongjiang
Dr Yu, 86-18980606909, gpyuyan@163.com
- Recruiting
Shandong Cancer Hospital
Jinan, Shandong, 250117
Prof. Tang, 86-13708938661, cot163@163.com
- Not yet recruiting
Jiangsu People's Hospital
Nanjing, Jiangsu
Dr. Guo, 86-13585145540, guorenhua@csco.ac.cn
- 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
- Not yet recruiting
First Affilicated Hospital of China Medical University
Shengyang, Liaoning
Dr Zhao, 86-13644055129, zhaomf618@126.com
- 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
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)
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. It will also measure the levels of two drugs in the body and preliminarily assess the anti-tumor activity with the combination treatment
- 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 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.
- 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Dizal Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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