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

NCT07838532 | Completed

• 2 other identifiers: NMU-AUMO-RWE-00172574107
• Study Type: observational
• Target: 637
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer; T790M; EGFR Activating Mutation

Keywords

Aumolertinib; EGFR tyrosine kinase inhibitor; real-world evidence; target trial emulation; overall survival; progression-free survival

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Overall survival is defined as the time from time zero, defined as the date of first recorded use of aumolertinib 110 mg once daily, to death from any cause. Vital status and date of death will be obtained through linkage with the Jiangsu resident mortality registry. Participants alive on December 31, 2024 will be administratively censored on that date. Kaplan-Meier methods will be used to estimate median OS and OS probabilities at 6, 9, 12, 24 and 48 months with 95% confidence intervals.

  From first use of aumolertinib to death from any cause or administrative censoring on December 31, 2024; up to 60 months.

Secondary Outcomes (2)

• Real-World Progression-Free Survival (rwPFS)

  From first use of aumolertinib to disease progression, death from any cause, or censoring; data available through December 31, 2024; up to 60 months.

• Incidence of Documented Adverse Events (AEs)

  From the first administration of aumolertinib until three months after discontinuation of aumolertinib, death or the date of the last available medical record, whichever occurs first; up to 60 months.

Other Outcomes (2)

• Treatment Discontinuation Due to Adverse Events

  From first use of aumolertinib to December 31, 2024, death, or last available healthcare record, whichever occurs first; up to 60 months.

• Dose Reduction Due to Adverse Events

  From first use of aumolertinib to December 31, 2024, death, or last available healthcare record, whichever occurs first; up to 60 months.

Study Arms (1)

Aumolertinib Real-World Cohort

Drug: Aumolertinib monotherapy （development code: HS-10296）

Interventions

Aumolertinib monotherapy （development code: HS-10296） DRUG

The study does not assign treatment. Exposure is defined by the first confirmed aumolertinib prescription, executed medication order, or administration in routine clinical practice. The approved regimen is 110 mg orally once daily. Actual dose modifications, discontinuation, switching, and treatment beyond progression will be captured from the medical record.

Aumolertinib Real-World Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will be drawn from outpatient and inpatient records of urban and rural residents of Jiangsu Province covered by the China Health and Medical Big Data Center (East). All records with aumolertinib exposure and a lung cancer-related code between January 1, 2020, and December 31, 2024, will undergo broad screening. The final cohort will be confirmed using pathology, disease stage, prior treatment, progression, and genetic testing results. Vital status will be linked by the data custodian within a secure environment to the Jiangsu Province Resident Death Registration Database. All patients' medical records have been anonymised.

You may qualify if:

• Age 18 years or older at time zero.
• Unresectable locally advanced, recurrent or metastatic non-small cell lung cancer.
• Prior continuous treatment with a first- or second-generation EGFR tyrosine kinase inhibitor and radiographic or clinical documentation of disease progression during or after the most recent relevant regimen.
• A documented positive EGFR T790M mutation result obtained after disease progression and before initiation of aumolertinib.
• There is a clear record of the date on which aumolertinib was first administered, and there is at least one complete record of an efficacy assessment following treatment.

You may not qualify if:

• Any record of treatment with a third-generation EGFR tyrosine kinase inhibitor before aumolertinib initiation.
• Inability to confirm any core requirement: non-small cell lung cancer, progression after a first- or second-generation EGFR TKI, or EGFR T790M positivity.
• Another active primary malignancy before time zero that, according to prespecified rules, could materially affect interpretation of survival outcomes.
• The medical records were incomplete.

Sponsors & Collaborators

• Xin Li: lead

Study Sites (1)

Nanjing Medical University

Nanjing, Jiangsu, 211166, China

Location

Related Publications (3)

• Ton TGN, Pal N, Trinh H, Mahrus S, Bretscher MT, Machado RJM, Sadetsky N, Chaudhary N, Lu MW, Riely GJ. Replication of Overall Survival, Progression-Free Survival, and Overall Response in Chemotherapy Arms of Non-Small Cell Lung Cancer Trials Using Real-World Data. Clin Cancer Res. 2022 Jul 1;28(13):2844-2853. doi: 10.1158/1078-0432.CCR-22-0471.

  PMID: 35511917 BACKGROUND

• Matthews AA, Danaei G, Islam N, Kurth T. Target trial emulation: applying principles of randomised trials to observational studies. BMJ. 2022 Aug 30;378:e071108. doi: 10.1136/bmj-2022-071108. No abstract available.

  PMID: 36041749 BACKGROUND

• Lu S, Wang Q, Zhang G, Dong X, Yang CT, Song Y, Chang GC, Lu Y, Pan H, Chiu CH, Wang Z, Feng J, Zhou J, Xu X, Guo R, Chen J, Yang H, Chen Y, Yu Z, Shiah HS, Wang CC, Yang N, Fang J, Wang P, Wang K, Hu Y, He J, Wang Z, Shi J, Chen S, Wu Q, Sun C, Li C, Wei H, Cheng Y, Su WC, Hsia TC, Cui J, Sun Y, Ou SI, Zhu VW, Chih-Hsin Yang J. Efficacy of Aumolertinib (HS-10296) in Patients With Advanced EGFR T790M+ NSCLC: Updated Post-National Medical Products Administration Approval Results From the APOLLO Registrational Trial. J Thorac Oncol. 2022 Mar;17(3):411-422. doi: 10.1016/j.jtho.2021.10.024. Epub 2021 Nov 19.

  PMID: 34801749 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, PhD, PhD supervisor, Deputy Dean of the School of Pharmacy, Nanjing Medical University

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 24, 2026
• Study Start: March 24, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 24, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)