An observational study in Non Small Cell Lung Cancer, T790M and EGFR Activating Mutation, sponsored by Xin Li. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Xin Li · Observational
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Among 1,878 studies in Carcinoma, Non-Small-Cell Lung with a site in China — 763 open to participants now, 986 under way, 203 of them phase 3. Carcinoma, Non-Small-Cell Lung · China.
Among the 1,878 studies in Carcinoma, Non-Small-Cell Lung with a site in China, this one is the 64th largest by enrollment of the 286 observational ones that give a count, is one of 135 that started in 2020, is one of 286 observational ones, and was the 1,851st registered.
7,624 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,837 are open to participants now.
Browse Carcinoma, Non-Small-Cell Lung studies →763 of the 1,878 studies in Carcinoma, Non-Small-Cell Lung with a site in China are open now. Recruiting first, the newest first:
Jiangsu Hansoh Pharmaceutical Co., Ltd. · Sites in China
Ages 18+
Sichuan Baili Pharmaceutical Co., Ltd. · Sites in China
Ages 18+
Ruijin Hospital · Sites in China
Ages 18+
Daiichi Sankyo · Sites in China, United States, Argentina and 10 more countries
Ages 18+
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Sites in China
Ages 18–80 · Healthy volunteers
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 1,326 Carcinoma, Non-Small-Cell Lung studies recruiting now, 988 (75%) set no upper age limit and 225 (17%) stop at 75 or younger; 34 take children under 18; 40 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,878 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 360 · Phase 2 847 · Phase 3 404 · Phase 4 40
First in 1996; this study’s year is marked. 135 started in 2020.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 637 is above the median of 160 across 1,148 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Median enrollment 100 across the 1,592 interventional studies, 200 across the 286 observational. Of the 453 that completed or were terminated, 130 (29%) have results posted.
This tab as a report to print or save as PDF → With an account.
803 of 1,878 have an industry lead sponsor. The 10 most frequent:
Xin Li is the lead sponsor of 2 studies on the registry; none are open to participants now.
Xin Li has 1 study filed under Carcinoma, Non-Small-Cell Lung — fewer than ten, so there is no comparison to draw.
225 of the studies in Carcinoma, Non-Small-Cell Lung with a site in China that are under way reach primary completion within a year, 33 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06448312Phase 3Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.A Study of SKB264 in Combination With Pembrolizumab Versus Pembrolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer | 2026-11 |
| NCT06704620Phase 3Tianjin Medical University Cancer Institute and HospitalStudy of Tislelizumab and Platinum-based Chemotherapy Combination With H1 Receptor Antagonist（Diphenhydramine）in Advanced and Metastatic Non-Small Cell Lung Cancer | 2026-11 |
| NCT05429463Phase 3Second Affiliated Hospital, Zhejiang University, School of MedicineNeoadjuvant Therapy of Sintilimab Combined With Chemotherapy for Resectable Squamous Cell NSCLC（neoSCORE Ⅱ） | 2026-11-30 |
| NCT06711900Phase 3Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.A Study of SKB264 in Combination With Pembrolizumab Versus Chemotherapy in Combination With Pembrolizumab as First-Line Treatment for PD-L1 Negative Patients With Locally Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer | 2026-12 |
| NCT06382129Phase 3Sichuan Baili Pharmaceutical Co., Ltd.A Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer(PANKU-Lung02) | 2026-12 |
Add all 225 to your calendar (.ics) → With an account.
Among the 1,878 studies in Carcinoma, Non-Small-Cell Lung with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Lung cancer is one of the leading causes of cancer burden worldwide, and non-small cell lung cancer accounts for most lung cancer cases. Sensitizing EGFR mutations are common oncogenic drivers among Chinese patients with advanced non-small cell lung cancer. First- and second-generation EGFR tyrosine kinase inhibitors provide substantial clinical benefit, but acquired resistance is nearly inevitable. EGFR T790M is an important resistance mechanism after progression on these agents. Third-generation EGFR tyrosine kinase inhibitors that selectively inhibit sensitizing EGFR mutations and T790M have therefore become an important subsequent treatment option for this population.
Aumolertinib is a third-generation EGFR tyrosine kinase inhibitor. The single-arm phase II APOLLO registrational study enrolled 244 patients with EGFR T790M-positive locally advanced or metastatic non-small cell lung cancer after progression on a prior EGFR tyrosine kinase inhibitor. The study reported an objective response rate of 68.9%, a disease control rate of 93.4%, and a median progression-free survival of 12.4 months. With longer follow-up, median overall survival was 30.2 months and the 24-month overall survival rate was 57.5%. The safety profile was considered acceptable in the trial setting. These findings supported conditional marketing authorization for this indication in China.
Although APOLLO provided pivotal evidence of clinical benefit, its single-arm design and restrictive eligibility criteria limit direct generalization to routine practice. Older patients and those with poorer performance status, comorbidities, organ dysfunction, complex metastatic patterns, or different prior treatment pathways are more frequently encountered in the real world. In addition, the frequency of imaging assessment, dose modification, treatment interruption, subsequent therapy, and completeness of follow-up may differ from those in a registrational trial. Real-world outcomes may therefore differ from trial results. A large real-world study with long-term follow-up can provide further evidence on the effectiveness and safety of aumolertinib and can also inform assessment of health care utilization, medical costs, and the value of health insurance reimbursement.
This is a population-based, retrospective, observational, single-cohort study using health care data from Jiangsu Province, China. The China Health and Medical Big Data Center (East) covers outpatient and inpatient care for approximately 80 million urban and rural residents and includes demographic characteristics, diagnoses, imaging and laboratory findings, clinical and pathology notes, prescriptions and medication orders, health care institutions, medical costs, and health insurance reimbursement. Broad screening will identify patients with a lung cancer-related code (C34 or D02.200) and a record of aumolertinib between January 1, 2020, and December 31, 2024. Final eligibility will be confirmed from pathology or cytology, disease stage, prior treatment, disease progression, and molecular testing records. Within a secure environment, patients will be linked through a unique card number to the Jiangsu Province Resident Death Registration Database to determine vital status through January 1, 2025. The study will not assign treatment, contact patients, or alter clinical care.
Time zero is the first confirmed aumolertinib prescription, executed medication order, or administration. Eligibility assessment, treatment initiation, and the start of outcome follow-up will be aligned at time zero. The primary outcome is overall survival, defined as the time from time zero to death from any cause. Secondary outcomes include real-world progression-free survival and adverse events. Real-world disease progression will be ascertained from treating clinician documentation, radiology reports, pathology findings, and longitudinal clinical records. An adverse event will be described as treatment-related only when causality is explicitly documented in the medical record.
Using target trial emulation principles, the study will prespecify and align eligibility criteria, treatment strategy, time zero, follow-up, outcomes, and analysis. An indication-aligned new-user cohort and a stricter trial-aligned cohort will be analyzed separately. Overall survival and real-world progression-free survival will be described using Kaplan-Meier methods, survival probabilities at fixed time points, and restricted mean survival time. For the trial-aligned cohort, where common variable definitions and data quality permit, an unanchored matching-adjusted indirect comparison will align measured characteristics with published APOLLO baseline distributions. Weight distributions, effective sample size, and residual imbalance will be reported. The comparison with APOLLO is a trial-to-practice benchmark intended to assess consistency and transportability of outcomes; it is not a randomized causal comparison of aumolertinib versus another treatment.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Aumolertinib monotherapy （development code: HS-10296）
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.
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.
Time frame: From first use of aumolertinib to death from any cause or administrative censoring on December 31, 2024; up to 60 months.
Real-World Progression-Free Survival (rwPFS)
rwPFS is defined as the time from first use of aumolertinib to the first recorded disease progression or death from any cause, whichever occurs first. Disease progression will be identified from clinical records, imaging reports, or medical documentation. Among patients with no documented progression, death within 91 days after the last documented progression-free assessment will be counted as a progression/death event on the date of death; death occurring more than 91 days after the last progression-free assessment, or no death, will result in censoring on the date of the last documented progression-free assessment. Patients with no post-index disease assessment or follow-up record will be excluded from the rwPFS analysis. Kaplan-Meier methods will estimate median rwPFS and rwPFS probabilities at 6, 9, 12, 24 and 48 months with 95% confidence intervals.
Time frame: 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)
Proportion of patients with at least one documented safety event or adverse event after initiation of aumolertinib. Events will be identified from outpatient, inpatient, clinical narrative, prescription, test results and medical order records using a prespecified algorithm and summarized by prespecified categories. As CTCAE grading and investigator-assessed causality are not systematically available, this outcome will not be interpreted as the incidence of CTCAE-graded treatment-related adverse events.
Time frame: 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.
Treatment Discontinuation Due to Adverse Events
Proportion of patients with a documented record of aumolertinib treatment discontinuation due to an adverse event.
Time frame: 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
Proportion of patients with a documented record of aumolertinib dose reduction due to an adverse event.
Time frame: From first use of aumolertinib to December 31, 2024, death, or last available healthcare record, whichever occurs first; up to 60 months.
Plan to share: No — IPD will not be shared because the ethics committee approval and informed consent obtained for this retrospective study do not include permission for secondary data sharing with third parties.
Ran from Mar 2020 to primary completion in Dec 2024, 57 months.
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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung →
Xin Li