Tests DZD6008 pill in advanced lung cancer with EGFR gene changes
Tests DZD6008 pill in adults with advanced lung cancer and EGFR changes.
Plain-language title generated from the registry record
Registry title: A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1)
Key facts
- Where
- Blacktown and Camperdown, AustraliaSee the 2 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced non-small cell lung cancer that carries an EGFR mutation. It tests the safety and anti-tumor effect of the drug DZD6008.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Non-small cell lung cancer that is locally advanced or has spread, and cannot be treated with treatment meant to remove all of the disease. Measurable disease per RECIST 1.1. ECOG 0 or 1, expected life span of at least 12 weeks. Brain metastases must be stable.
- Earlier treatment
- Part A: the cancer got worse on, or the person could not tolerate, at least 1 earlier EGFR TKI treatment. Part B cohort A: failed 1 earlier third-generation EGFR TKI. Part B cohort B: no earlier treatment.
- Biomarker or test result
- An EGFR mutation confirmed by a local certified laboratory. Part A monotherapy cohorts and all Part B cohorts need an EGFR sensitizing mutation (Exon19del and/or L858R). A tumor sample is needed.
Main reasons for not taking part
- Other EGFR changes besides T790M and C797X, such as uncommon mutations or exon 20 insertions (Part B)
- Mixed small cell lung cancer or change of the tumor into small cell type
- Spinal cord compression or cancer in the membranes around the brain (leptomeningeal metastasis)
- Past or active interstitial lung disease (ILD)
- Pregnant or breastfeeding women
Read by machine on 9 November 2026.
Where in Australia
- Blacktown HospitalBlacktown, AustraliaNo longer taking part
- Chris O'Brien LifehouseCamperdown, AustraliaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Dizal Pharmaceuticals
- Trial code
- NCT06905197
- Record updated
- 23 October 2026
- Original description
This study is designed to evaluate safety and anti-tumor activity of DZD6008 in patients with advanced NSCLC with EGFR mutations.Read full original descriptionShow less
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)
This study is designed to evaluate safety and anti-tumor activity of DZD6008 in patients with advanced NSCLC with EGFR mutations.
Inclusion: 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 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; 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); 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; 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.
Exclusion: 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; Received a live vaccine within 2 weeks before the first administration of DZD6008; NSCLC with mixed small cell lung cancer (SCLC) or NSCLC with histologic SCLC transformation; Patients with any other malignancy within 2 years of the first administration of study drug; 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; Past medical history of ILD or active ILD; Diseases which would preclude adequate absorption of DZD6008; Hypersensitivity to active or inactive excipients of DZD6008 or sunvozertinib; 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); 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; Spinal cord compression or leptomeningeal metastasis; Women who are pregnant or breastfeeding; Involvement in the planning and conduct of the study; Judgment by the investigator that the patient is unlikely to comply with study procedures.