Title: A multicenter, open-label, phase IIb study to evaluate the efficacy and safety of sutetinib maleate capsule in locally advanced or metastatic NSCLC (non-resistant uncommon EGFR mutations only, including L861Q, G719X, and/or S768I)
Principal Investigator: Anthony Lam, MD, of OPN Healthcare in Glendale, California
Description: Researchers are conducting a phase 2b study to evaluate sutetinib maleate in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with non-resistant, uncommon EGFR mutations.
Patients will receive sutetinib maleate capsules by mouth for up to 13 cycles.
The primary outcome is the objective response rate. Secondary outcomes include duration of response, disease control rate, progression-free survival, time to progressive disease, time to response, time to treatment failure, overall survival, and more.
To be eligible for this study, patients must be 18 years of age or older. They must have locally advanced or metastatic NSCLC with a non-resistant, uncommon EGFR mutation, including L861Q, G719X, and/or S768I. They must have received no more than 1 prior line of chemotherapy. For a complete list of eligibility criteria, please see the reference.
This study is sponsored by Teligene US.
ClinicalTrials.gov. Study to evaluate sutetinib maleate capsule in locally advanced or metastatic non-small cell lung cancer. NCT05168566. Accessed May 22, 2023.