Clinical Research Directory

A Multicenter Exploratory Clinical Study of Iruplaltinib Combined With Pemetrexed as Neoadjuvant Therapy for Resectable ALK-Positive Non-Squamous Non-Small Cell Lung Cancer

This is a single-arm clinical study planning to enroll 30 treatment-naive patients with resectable ALK-positive non-squamous non-small cell lung cancer (NSCLC). The study consists of two phases: a safety lead-in phase and an expansion phase. Safety Lead-in Phase A total of 6 subjects will be enrolled and treated with the regimen: iruplaltinib 60 mg orally once daily on Days 1-7, followed by 180 mg orally once daily starting on Day 8, combined with pemetrexed 500 mg/m² intravenously every 3 weeks for one cycle (3 weeks). Adopting the modified Toxicity Probability Interval-2 (mTPI-2) design with a target dose-limiting toxicity (DLT) rate of 30%, DLTs occurring within the 21-day observation period after the first dose among the 6 subjects will be evaluated. Unlike standard mTPI-2 design with decisions of "stay" or "escalate", if the decision in this safety lead-in phase is "stay" or "escalate", the lead-in phase will be completed and the study will proceed to the expansion phase. If the decision is "de-escalate" or "exclude this dose from the study", the study will be terminated. Expansion Phase Eligible screened patients will receive iruplaltinib (60 mg po QD d1-7; then 180 mg po QD starting on Day 8) plus pemetrexed (500 mg/m² iv Q3W). Patients will receive 6 weeks of pre-operative treatment followed by curative resection, which is scheduled to be performed within 4 weeks after completion of neoadjuvant therapy. Patients with progressive disease (PD) will receive subsequent therapy such as alectinib or brigatinib at the investigator's discretion. Four weeks after curative surgery, patients will receive adjuvant iruplaltinib for up to 2 years.