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Lung cancer trial recreated using patient records – no new drugs needed

NCT ID NCT06675695

Knowledge-focused Sponsor: Brigham and Women's Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This completed study looked at nearly 5,000 people with non-small cell lung cancer to see if information from electronic health records could produce the same results as a famous clinical trial called FLAURA. Researchers compared patients who started taking osimertinib to those on older drugs (erlotinib or gefitinib) using real-world data. The goal was not to test a new treatment, but to learn whether real-world data can be trusted to answer important medical questions.

What this could mean

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

What this could lead to
If successful, this could show that real-world data can reliably mimic clinical trials, potentially speeding up future research and reducing costs.
What could go wrong
This is an observational study, not a new treatment trial. It cannot prove cause and effect, and results may not match the original trial due to data limitations.

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

4,864 people

The number who actually took part.

Started

Oct 2024

Finished

Nov 2025

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

Patients with locally advanced or metastatic EGFR sensitizing mutation (EGFRm+) Non-small Cell Lung Cancer (NSCLC) who are treatment-naïve and eligible for first-line treatment with an EGFR-TKI

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.

Market availability of osimertinib began April 18, 2018. Study Period: ENCORE database 1 (EDB1): Patient identification period: 01/01/2011-04/30/2024 with follow-up information through data cut-off date on 04/30/2024 ENCORE database 2 (EDB2): Follow-up information through 02/24/2023 (there is no specific time period restrictions for patient eligibility) ENCORE database 4 (EDB4): Patient identification period: 10/01/2018-09/30/2023 with follow-up information through data cut-off date on 09/30/2023. Inclusion Criteria: * Age \>= 18 * New users of first-line antineoplastic system therapy: osimertinib, gefitinib, or erlotinib for advanced/metastatic disease * Mention of 'adenocarcinoma' histology ('non-squamous' in EDB1) * Line of therapy setting needs to be 'advanced' (EDB1), 'metastatic' (EDB2) or there needs to be evidence of metastatic disease at time of treatment initiation (EDB4) * Evidence of any EGFR mutation in the 180 days before/on treatment initiation * Treatment needs to be first-line for advanced (EDB1) or metastatic (EDB2) disease or patients with prior exposure to any potential antineoplastic treatment commonly used in the advanced/metastatic NSCLC setting are excluded (EDB4) * ECOG 0 or 1 in the 90 days before/on treatment initiation Exclusion Criteria: * Missing age * Concurrent primary malignancies (EDB2) * Missing date of diagnosis or clinician note in the EHR (EDB2) * Only one visit at provider site (EDB2) * Metastatic (includes leukemias and multiple myeloma) for a malignancy diagnosed prior to the malignancy of interest with the presence of low grade (inclusive of grades 1 and 2) neuroendocrine histology (EDB2) * Participation in any clinical trial at any point in treatment history (EDB4)

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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.

Non-small cell lung cancer

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02120, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.