Phase 1 Study of Oral DZD6008 for Safety and Effectiveness in Advanced Non-Small Cell Lung Cancer with EGFR Mutations

What this Trial Is About

Researchers are evaluating the safety and anti-tumor activity of DZD6008, an oral EGFR inhibitor, in patients with advanced non-small cell lung cancer NSCLC that have EGFR mutations. This Phase 1, open-label study includes patients with locally advanced or metastatic NSCLC who have specific EGFR mutations and either have been previously treated with EGFR tyrosine kinase inhibitors TKIs or are treatment-nave. The study aims to better understand how DZD6008 works in this patient group and assess its tolerability and anti-cancer effects. The study has two parts Part A focuses on dose escalation, enrolling patients who have failed at least one prior EGFR TKI therapy. Multiple dose levels of DZD6008 are tested, ranging from 20 mg to 150 mg daily, including combination cohorts. Part B is a dose expansion phase that includes patients who have either failed one line of third-generation EGFR TKI or are treatment-nave, to further evaluate selected doses of DZD6008. Participants take the study drug orally once daily during these periods. Participants will undergo regular safety and tumor assessments throughout the study, typically for about one year. Researchers will monitor blood levels of DZD6008 and its metabolites, assess tumor response using RECIST 1.1 criteria, and evaluate overall tolerability. Safety evaluations include laboratory tests, ECGs, and monitoring for adverse events. The study collects tumor samples before treatment and tracks disease progression and patient well-being during follow-up.

A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1)