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Real-World check: Osimertinib's performance in spanish lung cancer patients under the microscope

NCT ID NCT06068049

Knowledge-focused Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 21, 2026 · Updated 4 times

Summary

This study observes 500 Spanish patients with EGFR-mutated non-small cell lung cancer who are taking osimertinib in routine care. It aims to measure survival, quality of life, and how long patients stay on treatment. The goal is to see if results from clinical trials hold up in real life, especially for groups often left out of studies, like older patients.

What this could mean

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

Active substance
osimertinib
What this could lead to
If successful, this study could confirm that osimertinib works as well in real-world settings as in clinical trials, especially for older patients or those with rare mutations.
What could go wrong
This is an observational study, not a controlled trial, so results may be less reliable. It only looks at patients in Spain, so findings may not apply elsewhere.

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

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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 include all adult EGFRm NSCLC patients receiving osimertinib according to SmPC.

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: * Female or male patients, treated with osimertinib * Age ≥ 18 years at starts of osimertinib treatment (i.e., index date). * Patients histologically diagnosed with EGFRm NSCLC (before index date): * Patients with first-line treatment with EGFRm locally advanced or metastatic NSCLC, not amenable to curative surgery or radiotherapy (Cohort 1). * Patients with stage IB-IIIA whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, after complete tumor resection (Cohort 2). * Patients with advanced NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, that received osimertinib in combination with pemetrexed and platinum-based chemotherapy for the first-line treatment (Cohort 3). * Patients with locally advanced, unresectable NSCLC treated with osimertinib, whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum-based chemoradiation therapy (cohort 4). * Provision of informed consent (for alive patients). Deceased patients who met the selection criteria when they started treatment with osimertinib could also be included in the study. Exclusion Criteria: * Osimertinib treatment administration in a clinical trial setting.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    RECRUITING

    A Coruña, Spain

  • Research Site

    RECRUITING

    Alicante, Spain

  • Research Site

    RECRUITING

    Barcelona, Spain

  • Research Site

    RECRUITING

    C Rdoba, Spain

  • Research Site

    RECRUITING

    El Palmar, Spain

  • Research Site

    RECRUITING

    Girona, Spain

  • Research Site

    RECRUITING

    Granada, Spain

  • Research Site

    RECRUITING

    Jaén, Spain

  • Research Site

    RECRUITING

    Las Palmas de Gran Canaria, Spain

  • Research Site

    RECRUITING

    León, Spain

  • Research Site

    RECRUITING

    Lleida, Spain

  • Research Site

    RECRUITING

    Madrid, Spain

  • Research Site

    WITHDRAWN

    Madrid, Spain

  • Research Site

    RECRUITING

    Málaga, Spain

  • Research Site

    RECRUITING

    Ourense, Spain

  • Research Site

    RECRUITING

    Palma, Spain

  • Research Site

    RECRUITING

    Sabadell, Spain

  • Research Site

    RECRUITING

    Salamanca, Spain

  • Research Site

    RECRUITING

    Santa Cruz de Tenerife, Spain

  • Research Site

    ACTIVE_NOT_RECRUITING

    Santander, Spain

  • Research Site

    RECRUITING

    Santiago de Compostela, Spain

  • Research Site

    RECRUITING

    Seville, Spain

  • Research Site

    RECRUITING

    Valencia, Spain

  • Research Site

    RECRUITING

    Valladolid, Spain

  • Research Site

    RECRUITING

    Vigo, Spain

  • Research Site

    RECRUITING

    Zaragoza, Spain

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