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 Mutation (TIAN-SHAN1)

This study is a Phase 1 clinical trial, which means it is the first stage of testing a new drug in humans to evaluate its safety, determine how the body processes it, and identify any potential side effects. The drug being studied, DZD6008, is investigational, meaning it has not been approved by the U.S. Food and Drug Administration (FDA). This study is evaluating the study drug, DZD6008, in patients with advanced non small cell lung cancer (NSCLC) harboring an epidermal growth factor receptor (EGFR) mutation. EGFR is a protein that is important in regulating activities in cell proliferation. The main purpose of the study is to learn if the study drug is safe and tolerable (if it will cause harmful effects), and effectiveness in patients diagnosed with advanced NSCLC with positive EGFR gene mutations. The study will also measure concentration levels of study drug, DZD6008, in plasma, and explore how the human body takes up, breaks down, and clears the study drug (and metabolites if applicable), a field of study that is known as pharmacokinetics (PK). Additional analyses may be conducted with PK blood samples to further study possible drug metabolites or validate the analytical method.

Are you Eligible? (Inclusion Criteria)

• Be able to understand the nature of the trial and provide a signed and dated written informed consent form (ICF) prior to any study specific procedures, sampling, and analyses. 2. Aged at least 18 years old (or per local regulatory/IRB requirement). 3. Females of childbearing potential should use reliable contraceptives from the time of screening until 6 weeks after discontinuation of study drug. Female participants should not be breastfeeding and must have a negative pregnancy test prior to starting dosing or must fulfill one of the following criteria at screening: • Post-menopausal is defined as aged more than 50 years and amenorrhea for at least 12 months following cessation of all exogenous hormonal treatment. • Women under 50 years old will be considered postmenopausal if they have been amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments and with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range. • Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.