OncoMatch/Clinical Trials/NCT07079475
Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8)
Is NCT07079475 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including DZD6008 and Sunvozertinib for non-small cell lung cancer.
Treatment: DZD6008 · Sunvozertinib · Osimertinib — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: EGFR mutation
Documentation of EGFR mutation from a local certified laboratory. Part A: EGFR mutations (excluding participants only harboring EGFR exon20ins).
Required: EGFR sensitizing mutation
Part B: EGFR sensitizing mutations (Exon19del and/or L858R) with or without T790M/C797S resistance mutations.
Excluded: EGFR exon20ins
Part A: EGFR mutations (excluding participants only harboring EGFR exon20ins). For part A: participants only harboring EGFR exon20ins（harboring other EGFR mutations could be enrolled） [excluded].
Allowed: EGFR T790M
Part B: EGFR sensitizing mutations (Exon19del and/or L858R) with or without T790M/C797S resistance mutations.
Allowed: EGFR C797S
Part B: EGFR sensitizing mutations (Exon19del and/or L858R) with or without T790M/C797S resistance mutations.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: third-generation EGFR TKI (osimertinib)
should have failed (progressed on or are intolerant to) one line of third-generation EGFR TKI regimen (such as Osimertinib)
Cannot have received: third-generation EGFR TKI
Previously received two or more than two lines of third-generation EGFR TKI treatment
Cannot have received: systemic anti-cancer therapy
Exception: only for B3 cohort
Previously received systemic anti-cancer therapy for advanced disease (only for B3 cohort)
Cannot have received: immunotherapy or other antibody therapy
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 administration, radiation to more than 30% of the bone marrow or with a wide field of radiation within 28 days of the first administration
Lab requirements
Blood counts
adequate hematopoietic function
Kidney function
adequate organ system functions
Liver function
adequate 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 [excluded]
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 [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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