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
• 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.
• 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.