This is a phase Ⅰb, multicenter study to evaluate safety, tolerability, pharmacokinetics, and efficacy of HS-10241 administered orally in combination with Almonertinib in patients with EGFRm+ locally advanced or metastatic NSCLC who have progressed following prior EGFR-TKI therapy.~The study consist of two parts: Part 1 is the dose escalation period to observe the safety, tolerance, PK characteristics and preliminary anti-tumor activity, and determine the maximum tolerated dose (MTD) or maximum applicable dose (MAD) of combined administration; Part 2 is the dose expansion period to select appropriate doses in different target populations and further evaluate the efficacy, safety, tolerance and PK characteristics of combined administration, and determine the phase II recommended dose (RP2D).~All patients will be carefully followed for adverse events during the study treatment and for 28 days after the last dose of study drug. Patients of this study will be permitted to continue therapy with assessments for progression once every 8 weeks, if the product is well tolerated and the subject has stable disease or better. Survival follow-up is recommended once every 12 weeks.
This study is conducted to determine the safety, tolerability, pharmacokinetics and anti-tumor activity of HS-10241 when given together with Almonertinib in patients with EGFRm+ advanced NSCLC.