OncoMatch/Clinical Trials/NCT06813365
Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN2)
Is NCT06813365 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies DZD6008 for nonsmall-cell lung cancer.
Treatment: DZD6008 — This study is designed to evaluate safety and antitumor activity of DZD6008 in patients with advanced NSCLC with EGFR mutations. This is the first time the drug is tested in human.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR exon 19 deletion
Documentation of EGFR sensitizing mutation (Exon19del and/or L858R)
Required: EGFR L858R
Documentation of EGFR sensitizing mutation (Exon19del and/or L858R)
Excluded: EGFR G719X
Carry any other known EGFR alterations, including but not limited to uncommon EGFR mutations (G719X, S768I, L861Q, exon 20 insertions, etc.)(Part B)
Excluded: EGFR S768I
Carry any other known EGFR alterations, including but not limited to uncommon EGFR mutations (G719X, S768I, L861Q, exon 20 insertions, etc.)(Part B)
Excluded: EGFR L861Q
Carry any other known EGFR alterations, including but not limited to uncommon EGFR mutations (G719X, S768I, L861Q, exon 20 insertions, etc.)(Part B)
Excluded: EGFR exon 20 insertions
Carry any other known EGFR alterations, including but not limited to uncommon EGFR mutations (G719X, S768I, L861Q, exon 20 insertions, etc.)(Part B)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: EGFR tyrosine kinase inhibitor
Part A: Failed (progressed or are intolerant) at least 1 prior EGFR TKI
Must have received: platinum-based chemotherapy
Part A: Failed (progressed or are intolerant) at least 1 prior EGFR TKI and platinum-based chemotherapy
Must have received: third-generation EGFR TKI
Part B: Cohorts 1 and 2: Failed 1 prior third-generation EGFR TKI
Cannot have received: immunotherapy or other antibody therapy
Prior treatment with any of the following:1)Immunotherapy or other antibody therapy within 4 weeks prior to the first administration
Cannot have received: cytotoxic chemotherapy
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
Cannot have received: radiation therapy
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
Lab requirements
Blood counts
Adequate hematopoietic and other organ system functions
Kidney function
Adequate hematopoietic and other organ system functions
Liver function
Adequate hematopoietic and other organ system functions
Cardiac function
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
Adequate hematopoietic and other organ system functions. 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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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