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A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1) | Clinical Trials | Clareo Health

RECRUITINGPHASE1

A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1)

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)

NCT06905197•Dizal Pharmaceuticals

View on ClinicalTrials.gov

Summary

This study is designed to evaluate safety and anti-tumor activity of DZD6008 in patients with advanced NSCLC with EGFR mutations.

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients must be able to provide documented informed consent.
•2. Aged ≥ 18 years.
•3. Histologically or cytologically confirmed diagnosis of NSCLC, locally advanced or metastatic, not suitable for curative therapy.
•4. 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.
•5. 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).
•6. 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.
•7. ECOG 0 or 1 with predicted life expectancy ≥ 12 weeks.
•8. Patients with brain metastases must have a stable BM status.
•9. Measurable disease per RECIST 1.1.
•10. Adequate hematopoietic and other organ system functions.
+1 more criteria

Exclusion Criteria

•1. 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).
•2. NSCLC with mixed small cell lung cancer (SCLC) or NSCLC with histologic SCLC transformation.
•3. 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.
•4. Any unresolved toxicities from prior anti-cancer therapy greater than CTCAE Grade 1.
•5. Spinal cord compression or leptomeningeal metastasis.
•6. Patients with any other malignancy within 2 years of the first administration of study drug.
•7. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses as judged by investigator.
•8. Patients with active infection, including but not limited to HBV, HCV, HIV and active infection of COVID-19.
•9. 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.
•10. Past medical history of ILD or active ILD.
+6 more criteria

Locations (5)

Laura and Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, United States

Herbert Irving Comprehensive Cancer Center

New York, New York, United States

Virginia Cancer Specialist (NEXT Oncology-Virginia)

Fairfax, Virginia, United States

Blacktown Hospital

Blacktown, New South Wales, Australia

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

Key Dates

Start Date

May 13, 2025

Primary Completion Date

September 1, 2027

Completion Date

December 1, 2028

Last Updated

February 27, 2026

Enrollment

140

ESTIMATED participants

Conditions

Non Small Cell Lung Cancer

Interventions

DZD6008

DRUG

Sunvozertinib

DRUG

Contacts

Yifan Liu

CONTACT

86-21-61095854 yifan.liu@dizalpharma.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1)

Inclusion Criteria

Exclusion Criteria

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