JS111 in Patients With Advanced NSCLC Harboring EGFR Mutations

This is a Phase II clinical study evaluating JS111 capsules (AP-L1898) as monotherapy in patients with advanced NSCLC harboring EGFR mutations.Approximately 3 to 42 treatment-naïve patients with EGFR mutation-positive locally advanced, metastatic, or recurrent NSCLC will be enrolled.Based on prior safety, PK, and efficacy data, two dose levels-160 mg QD and 240 mg QD-will be tested to assess safety, tolerability, PK, and preliminary efficacy, and to determine the recommended Phase II dose (RP2D), as referenced in Section 4.3. The study includes two parts: Part 1: Each dose group will enroll 3-12 subjects who will receive oral JS111 capsules daily until meeting treatment discontinuation criteria. Once all subjects complete at least the Day 21 observation following the first dose 21 days of treatment , the Safety Monitoring Committee (SMC) will review the data to decide whether to: 1. Select RP2D for further enrollment; 2. Continue enrollment for further evaluation; 3. Explore other dose levels; 4. Amend or terminate the study if needed. Subjects who receive \<80% of planned doses or discontinue for non-drug-related reasons during the 21-day period will be replaced. Mutation subtypes (exon 19 deletion or exon 21 L858R) will be evenly assigned across dose groups, starting from the lower dose. Part 2: Subjects will be enrolled into the RP2D cohort until \~30 patients have been treated with the dose. Subjects from the other group may continue on the same dose or switch to RP2D as appropriate. JS111 will be taken once daily in 21-day cycles to further assess safety, PK, and preliminary efficacy.