AzTrials
AzTrials

EGFR-mutated NSCLCREMAINNCT07363252

Investigation of REcurrence Mechanisms to Adjuvant osimertINib in Radically Resected EGFR-mutated NSCLC Patients

An observational study of EGFR-mutated NSCLC, run by Gruppo Oncologico Italiano di Ricerca Clinica at 25 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Retrospective-prospective observational multicentric study including radically resected EGFR-mutated NSCLC patients relapsed during or after adjuvant osimertinib, received according to clinical practice Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
EGFR-mutated NSCLC
What is being tested?
Osimertinib
How many people
100 participants
Where
25 sitesItaly
Study dates
14 Apr 2026to Dec 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: 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

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

25 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Alessandro Leonetti, MD contact

+39 0521702682

aleonetti@ao.pr.it

Michele Tognetto contact

goirc-remain@goirc.org

25 sites in 1 country

Italy25 sites, 20 recruiting

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

    Aviano, PN, 33081

    Martina Bortolot, MD

    Not yet recruiting

  • IRCCS Oncologico Giovanni Paolo II

    Bari, BA, 70124

    Active, not recruiting

  • Asst Papa Giovanni Xxiii Sc Oncologia

    Bergamo, BG, 24127

    Anna Bettini, MD

    Not yet recruiting

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

    Bologna, BO, 40138

    Andrea De Giglio, MD

    Not yet recruiting

  • Grande Ospedale Metropolitano Niguarda Ca' Granda

    Milan, Michigan, 20162

    Active, not recruiting

  • Irccs Humanitas Research Hospital

    Milan, MI, 20089

    Luca Toschi, MD

    Not yet recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

    Milan, MI, 20113

    Marta Brambilla, MD

    Not yet recruiting

  • Ospedale San Raffaele Dipartimento di Oncologia Medica

    Milan, MI, 20132

    Alessandra Bulotta, MD

    Not yet recruiting

  • European Institute of Oncology IRCCS

    Milan, MI, 20141

    Antonio Passaro, MD

    Not yet recruiting

  • Humanitas Istituto Clinico Catanese Contrada Cubba

    Misterbianco, CT, 95045

    Alessandro Russo, MD

    Not yet recruiting

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

    Modena, Missouri, 41124

    Active, not recruiting

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

    Monza, MB, 20900

    Diego Cortinovis, MD

    Not yet recruiting

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

    Naples, 80131

    Alessandro Morabito, MD

    Not yet recruiting

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

    Novara, 28100

    Gloria Borra, MD

    Not yet recruiting

  • AOU San Luigi Gonzaga - SSD oncologia polmonare

    Orbassano, TO, 10043

    Silvia Novello, MD

    Not yet recruiting

  • UOC di Oncologia Medica 2 - IOV Istituto Oncologico Veneto

    Padova, PD, 35128

    Giulia Pasello, MD

    Not yet recruiting

  • UOC di Oncologia Medica Azienda Ospedaliero-Universitaria di Parma

    Parma, PR, 43126

    Alessandro Leonetti, MD

    Not yet recruiting

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

    Peschiera del Garda, VR, 37019

    Active, not recruiting

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

    Ravenna, RA, 48100

    Chiara Bennati, MD

    Recruiting

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

    Reggio Emilia, RE, 42123

    Active, not recruiting

  • Fondazione Policlinico Universitario Campus Bio-Medico

    Roma, RM, 00128

    Alessandro Cortellini, MD

    Not yet recruiting

  • Ifo-Istituto Regina Elena - Oncologia Medica 1

    Roma, RM, 00144

    Fabiana Cecere, MD

    Not yet recruiting

  • Fondazione Policlinico Universitario 'Agostino Gemelli' IRCCS

    Roma, RM, 00168

    Emilio Bria, MD

    Not yet recruiting

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

    Varese, VA, 21100

    Francesco Grossi, MD

    Not yet recruiting

  • AOU Integrata di Verona - Ospedale Borgo Trento

    Verona, VR, 37126

    Lorenzo Belluomini, MD

    Not yet recruiting

Other trials in Italy

About this study

Official title: Investigation of REcurrence Mechanisms to Adjuvant osimertINib in Radically Resected EGFR-mutated NSCLC Patients - REMAIN Study

Retrospective-prospective observational multicentric study including radically resected EGFR-mutated NSCLC patients relapsed during or after adjuvant osimertinib, received according to clinical practice

Read the detailed description

This study will include patients

  1. who have already received adjuvant osimertinib and who relapsed at the end of the treatment (off-treatment recurrence) and patients
  2. who relapsed during the treatment (on-treatment recurrence). Patients could be enrolled at the time or after the recurrence. Data regarding clinical features for each patient, including demographics and comorbidities, and clinical outcomes of adjuvant osimertinib will be collected.

NGS analysis will be centrally performed on tissue biopsy and/or liquid biopsy collected at the time of recurrence in EGFR-mutated NSCLC treated with adjuvant osimertinib. NGS will be also centrally performed on tissue samples collected at the time of surgery.

Being tested
Osimertinib
Keywords
EGFR-mutated NSCLC, adjuvant osimertinib, Recurrence
Medical subject headings
Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OsimertinibDrug

    Characterization of the molecular mechanisms of recurrence to adjuvant osimertinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary endpoint of the study is the frequency of new variant(s) detected by Next Generation Sequencing (NGS) Panel at the time of recurrence to adjuvant osimertinib in tissue and/or liquid biopsy

    The primary endpoint of the study is the frequency of new variant(s) detected by Next Generation Sequencing (NGS) Panel at the time of recurrence to adjuvant osimertinib in tissue and/or liquid biopsy

    Measured: 3 years

Secondary outcomes (3)

  1. Secondary endpoint

    • Frequency of new variant(s) in Next Generation Sequencing (NGS) Panel in tissue sample at the time of recurrence to adjuvant osimertinib compared to surgical/pre-osimertinib sample

    Measured: 3 years

  2. Secondary endpoint

    • percent of treatment options at disease relapse

    Measured: 3 years

  3. Secondary endpoint

    • Correlation of new variants in NGS and clinical features to the onset of recurrence (on treatment/off treatment)

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jan 2026
  2. Study start14 Apr 2026
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07363252
Sponsor's protocol ID
GOIRC-03-2024
Acronym
REMAIN
Status last verified
Jan 2026
First submitted
10 Dec 2025
Last updated
22 Apr 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of EGFR-mutated NSCLC, run by Gruppo Oncologico Italiano di Ricerca Clinica at 25 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Alessandro Leonetti, MD (+39 0521702682, aleonetti@ao.pr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary endpoint of the study is the frequency of new variant(s) detected by Next Generation Sequencing (NGS) Panel at the time of recurrence to adjuvant osimertinib in tissue and/or liquid biopsy (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07363252.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in