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)
Dizal Pharmaceuticals
Summary
This study is designed to evaluate safety and anti-tumor activity of DZD6008 in patients with advanced NSCLC with EGFR mutations.
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 range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 pa…
Interventions
- DrugDZD6008
Daily dose of DZD6008
- DrugSunvozertinib
Daily dose of Sunvozertinib
Locations (5)
- Laura and Isaac Perlmutter Cancer Center at NYU Langone HealthNew York, New York
- Herbert Irving Comprehensive Cancer CenterNew York, New York
- Virginia Cancer Specialist (NEXT Oncology-Virginia)Fairfax, Virginia
- Blacktown HospitalBlacktown, New South Wales
- Chris O'Brien LifehouseCamperdown, New South Wales