Real-World Study of Aumolertinib in Patients With Advanced EGFR T790M-Positive NSCLC

Registry record from ClinicalTrials.gov (NCT07838532). This is a study registration, not published results. Lead sponsor: Xin Li. Recruitment status: COMPLETED. Study type: OBSERVATIONAL. Enrollment: 637 participants (ACTUAL). Conditions: Non Small Cell Lung Cancer, T790M, EGFR Activating Mutation. Interventions: DRUG: Aumolertinib monotherapy （development code: HS-10296）. Primary outcome measures: Overall Survival (OS) , From first use of aumolertinib to death from any cause or administrative censoring on December 31, 2024; up to 60 months.. Brief summary: The single-arm phase II APOLLO study demonstrated favorable antitumor activity and an acceptable safety profile for aumolertinib in patients with EGFR T790M-positive locally advanced or metastatic non-small cell lung cancer after progression on a first- or second-generation epidermal growth factor receptor tyrosine kinase inhibitor, supporting conditional marketing authorization for this indication in China. However, registrational trials use restrictive patient selection, protocol-driven tumor assessment, and intensive follow-up, and APOLLO had no concurrent control group. Its findings may therefore not fully represent the more complex and heterogeneous patients treated in routine practice. As aumolertinib has been widely used in mainland China since approval, real-world evidence is needed to further evaluate its effectiveness and safety in clinical practice. AUMO-RWE is a retrospective observational cohort study based on health care data from Jiangsu Province, China. The study will use deidentified outpatient and inpatient records from the China Health and Medical Big Data Center (East), securely linked to the Jiangsu Province Resident Death Registration Database. Eligible participants will be adults who first initiated aumolertinib in routine care between January 1, 2020, and December 31, 2024, after progression on a first- or second-generation EGFR tyrosine kinase inhibitor and who have documented EGFR T790M-positive disease. The primary outcome is overall survival. Secondary outcomes include real-world progression-free survival and adverse events recorded during treatment. Tumor response, treatment patterns, health care utilization, medical costs, health insurance payments, and patient out-of-pocket payments will also be described. In addition, a trial-aligned cohort will be constructed using target trial emulation principles and key elements of the APOLLO protocol. Where data comparability permits, an unanchored matching-adjusted indirect comparison will standardize measured baseline characteristics of the real-world cohort to the published APOLLO population. This comparison is intended to describe and quantify trial-to-practice outcome differences and to inform clinical use and assessment of the value of health insurance reimbursement. Because both APOLLO and AUMO-RWE are single-arm aumolertinib cohorts, the comparison will not be interpreted as a randomized causal effect of aumolertinib versus another treatment.