Phase II Evaluation of AK146D1 Combined With AK112 or Osimertinib in Advanced Non-Small Cell Lung Cancer Treatment

What this Trial Is About

Researchers are evaluating the safety, tolerability, pharmacokinetics, and antitumor effects of the drug AK146D1 combined with AK112 or other anticancer treatments in patients with advanced non-small cell lung cancer NSCLC. This phase II study focuses on patients with locally advanced or metastatic NSCLC who are unable to undergo curative surgery or chemoradiotherapy. The study aims to understand how these combinations work and their impact on tumor response. Participants will be assigned to one of three groups one group receives AK146D1 combined with AK112 and platinum chemotherapy via intravenous infusion another group receives AK146D1 combined with osimertinib and the third group receives AK146D1 combined with AK112 via intravenous infusion. These treatments are given under medical supervision, with dosing schedules as per the study protocol. The treatments are being studied for up to approximately two years, with a safety run-in phase lasting the first three weeks. During the study, participants will be closely monitored through regular assessments including measuring tumor response using RECIST criteria, tracking progression-free survival, overall survival, and duration of response. Blood samples will be taken to study drug concentrations and immune responses. Safety will be monitored from consent through 30 to 90 days after the last dose. The total participation time may span up to the end of the study in 2029, with primary results expected by 2027.

A Phase II Study of AK146D1 in Combination With AK112 in Advanced Non-Small Cell Lung Cancer