Study of Oral JBI-802 Alone or With Pembrolizumab for Advanced Non-Small Cell Lung Cancer With STK11 Mutation

What this Trial Is About

Researchers are evaluating the safety and tolerability of an oral drug called JBI-802, both alone and combined with Pembrolizumab, in people with non-small cell lung cancer NSCLC that has an STK11 mutation. This phase 2, open-label study focuses on patients with advanced NSCLC bearing this specific mutation to understand how these treatments perform and their effects on the cancer. Participants will receive JBI-802 orally at a dose of 10 mg once daily, following a schedule of 4 days on treatment and 3 days off. Those in the combination group will also receive Pembrolizumab at 200 mg every three weeks. The study is non-randomized with two experimental arms one using JBI-802 alone and the other combining it with Pembrolizumab. During the study, participants will have regular assessments including scans to measure tumor response, laboratory tests to monitor safety, and evaluations of side effects. The primary outcomes are the incidence of adverse events and the investigator-assessed overall response rate up to 28 days after the last dose. Participants will be monitored closely throughout the treatment and follow-up periods to track how they respond to the therapies and to ensure safety.

A Study of Orally Administered JBI-802 Alone or in Combination With Pembrolizumab for Patients With Non-small Cell Lung Cancer With an STK11 Mutation.