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Lung cancer relapse mystery: new study digs into genetic clues

NCT ID NCT07363252

Knowledge-focused Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study looks at 100 people with a specific type of lung cancer (EGFR-mutated NSCLC) whose cancer came back during or after treatment with the drug osimertinib. Researchers want to find out what new genetic changes appear when the cancer returns. This is an observational study, meaning no new treatment is given—just analysis of tumor samples to better understand why resistance happens.

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 100 people

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

Started

Apr 2026

Expected to finish

Dec 2028

An estimate. End dates often move.

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

100 relapsed EGFR-mutated NSCLC patient receiving osimertinib in adjuvant setting and with tissue biopsy and/or liquid biopsy collected at the time of recurrence

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 * Diagnosis of radically resected IB-IIIA NSCLC with EGFR activating mutation * Treatment with adjuvant osimertinib (starting from September 2022, date of approval) according to clinical practice * Recurrence of disease during or after adjuvant therapy with osimertinib received according to clinical practice * Availability of tissue and/or liquid biopsy sample collected at the time of recurrence * Signed informed consent. * Exclusion Criteria: * Unavailability of tissue and/or liquid biopsy sample collected at the time of recurrence * Concomitant synchronous malignancies aside from NSCLC or any concurrent and/or active malignancy that has required treatment within 2 years * Involvement in the planning and/or conduct of the study (applies to both investigator staff and/or staff at the study site).

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma Recurrence

As listed by the trial registrant

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

EGFR-mutated NSCLC

How to take part

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

  1. The places running it

    20 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

  • "OSPEDALE P. PEDERZOLI" Casa di Cura Privata S.p.A.

    ACTIVE_NOT_RECRUITING

    Peschiera del Garda, VR, 37019, Italy

  • A.O.U. "Maggiore della Carita'"- S.C.D.U Oncologia

    NOT_YET_RECRUITING

    Novara, 28100, Italy

  • A.S.S.T - Monza Ospedale San Gerardo

    NOT_YET_RECRUITING

    Monza, MB, 20900, Italy

  • AOU Integrata di Verona - Ospedale Borgo Trento

    NOT_YET_RECRUITING

    Verona, VR, 37126, Italy

  • AOU San Luigi Gonzaga - SSD oncologia polmonare

    NOT_YET_RECRUITING

    Orbassano, TO, 10043, Italy

  • Asst Papa Giovanni Xxiii Sc Oncologia

    NOT_YET_RECRUITING

    Bergamo, BG, 24127, Italy

  • Dip Oncologia-Ematologia - UO Oncologia AOU Policlinico di Modena

    ACTIVE_NOT_RECRUITING

    Modena, Missouri, 41124, Italy

  • European Institute of Oncology IRCCS

    NOT_YET_RECRUITING

    Milan, MI, 20141, Italy

  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

    NOT_YET_RECRUITING

    Milan, MI, 20113, Italy

  • Fondazione Policlinico Universitario 'Agostino Gemelli' IRCCS

    NOT_YET_RECRUITING

    Roma, RM, 00168, Italy

  • Fondazione Policlinico Universitario Campus Bio-Medico

    NOT_YET_RECRUITING

    Roma, RM, 00128, Italy

  • Grande Ospedale Metropolitano Niguarda Ca' Granda

    ACTIVE_NOT_RECRUITING

    Milan, Michigan, 20162, Italy

  • Humanitas Istituto Clinico Catanese Contrada Cubba

    NOT_YET_RECRUITING

    Misterbianco, CT, 95045, Italy

  • IRCCS Oncologico Giovanni Paolo II

    ACTIVE_NOT_RECRUITING

    Bari, BA, 70124, Italy

  • Ifo-Istituto Regina Elena - Oncologia Medica 1

    NOT_YET_RECRUITING

    Roma, RM, 00144, Italy

  • Irccs Humanitas Research Hospital

    NOT_YET_RECRUITING

    Milan, MI, 20089, Italy

  • Oncologia Clinica Sperimentale Toraco-Polmonare, IRCCS Pascale di Napoli

    NOT_YET_RECRUITING

    Naples, 80131, Italy

  • Ospedale San Raffaele Dipartimento di Oncologia Medica

    NOT_YET_RECRUITING

    Milan, MI, 20132, Italy

  • S.C. Oncologia Provinciale, Azienda USL-IRCCS di Reggio Emilia

    ACTIVE_NOT_RECRUITING

    Reggio Emilia, RE, 42123, Italy

  • S.O.C. di Oncologia Medica e dei Tumori Immuno-correlati, Centro di Riferimento Oncologico IRCCS

    NOT_YET_RECRUITING

    Aviano, PN, 33081, Italy

  • SC Oncologia ASST Sette Laghi "Ospedale di Circolo e Fondazione Macchi "

    NOT_YET_RECRUITING

    Varese, VA, 21100, Italy

  • U.O.C. Oncologia Medica Azienda Unità Sanitaria Locale della Romagna

    RECRUITING

    Ravenna, RA, 48100, Italy

  • UOC di Oncologia Medica 2 - IOV Istituto Oncologico Veneto

    NOT_YET_RECRUITING

    Padova, PD, 35128, Italy

  • UOC di Oncologia Medica Azienda Ospedaliero-Universitaria di Parma

    NOT_YET_RECRUITING

    Parma, PR, 43126, Italy

  • UOC di Oncologia Medica IRCCS - Policlinico S. Orsola Malpighi

    NOT_YET_RECRUITING

    Bologna, BO, 40138, Italy

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