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Does a daily pill hold up outside the trial? Real-World lung cancer data put aumolertinib to the test

NCT ID NCT07838532

Disease control Sponsor: Xin Li Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 24, 2026 · Last updated Sep 25, 2026 · Updated 1 time

Summary

Researchers are examining how well aumolertinib works and how safe it is in everyday practice for adults with advanced non-small cell lung cancer that has an EGFR T790M mutation and has worsened after an earlier EGFR drug. The study reviews deidentified medical records from Jiangsu Province, China, for patients who started aumolertinib in routine care between 2020 and 2024. It tracks overall survival, time until cancer progression or death, and side effects, and compares these real-world outcomes with those from the earlier APOLLO trial.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
aumolertinib, an EGFR-targeted lung cancer drug taken as a daily pill
What this could lead to
If the real-world data match the earlier trial, this could strengthen confidence that aumolertinib helps similar patients outside strict research settings and support decisions about insurance coverage.
What could go wrong
This is a retrospective look at medical records, not a randomized comparison, so differences in patients and care could distort the results. It cannot prove that aumolertinib causes any particular outcome.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

637 people

The number who actually took part.

Started

Mar 2020

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

EGFR activating mutation Non small cell lung cancer T790M

Contacts and locations

Locations

  • Nanjing Medical University

    Nanjing, Jiangsu, 211166, China

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