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

April 17, 2026 updated by: Gruppo Oncologico Italiano di Ricerca Clinica

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
      • Naples, Italy, 80131
        • Not yet recruiting
        • Oncologia Clinica Sperimentale Toraco-Polmonare, IRCCS Pascale di Napoli
        • Contact:
          • Alessandro Morabito, MD
      • Novara, Italy, 28100
        • Not yet recruiting
        • A.O.U. "Maggiore della Carita'"- S.C.D.U Oncologia
        • Contact:
          • Gloria Borra, MD
    • BA
      • Bari, BA, Italy, 70124
        • Active, not recruiting
        • IRCCS Oncologico Giovanni Paolo II
    • BG
      • Bergamo, BG, Italy, 24127
        • Not yet recruiting
        • Asst Papa Giovanni Xxiii Sc Oncologia
        • Contact:
          • Anna Bettini, MD
    • BO
      • Bologna, BO, Italy, 40138
        • Not yet recruiting
        • UOC di Oncologia Medica IRCCS - Policlinico S. Orsola Malpighi
        • Contact:
          • Andrea De Giglio, MD
    • CT
      • Misterbianco, CT, Italy, 95045
        • Not yet recruiting
        • Humanitas Istituto Clinico Catanese Contrada Cubba
        • Contact:
          • Alessandro Russo, MD
    • MB
      • Monza, MB, Italy, 20900
        • Not yet recruiting
        • A.S.S.T - Monza Ospedale San Gerardo
        • Contact:
          • Diego Cortinovis, MD
    • MI
      • Milan, MI, Italy, 20089
        • Not yet recruiting
        • Irccs Humanitas Research Hospital
        • Contact:
          • Luca Toschi, MD
      • Milan, MI, Italy, 20113
        • Not yet recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
        • Contact:
          • Marta Brambilla, MD
      • Milan, MI, Italy, 20132
        • Not yet recruiting
        • Ospedale San Raffaele Dipartimento di Oncologia Medica
        • Contact:
          • Alessandra Bulotta, MD
      • Milan, MI, Italy, 20141
        • Not yet recruiting
        • European Institute of Oncology IRCCS
        • Contact:
          • Antonio Passaro, MD
    • Michigan
      • Milan, Michigan, Italy, 20162
        • Active, not recruiting
        • Grande Ospedale Metropolitano Niguarda Ca' Granda
    • Missouri
      • Modena, Missouri, Italy, 41124
        • Active, not recruiting
        • Dip Oncologia-Ematologia - UO Oncologia AOU Policlinico di Modena
    • PD
      • Padova, PD, Italy, 35128
        • Not yet recruiting
        • UOC di Oncologia Medica 2 - IOV Istituto Oncologico Veneto
        • Contact:
          • Giulia Pasello, MD
    • PN
      • Aviano, PN, Italy, 33081
        • Not yet recruiting
        • S.O.C. di Oncologia Medica e dei Tumori Immuno-correlati, Centro di Riferimento Oncologico IRCCS
        • Contact:
          • Martina Bortolot, MD
    • PR
      • Parma, PR, Italy, 43126
        • Not yet recruiting
        • UOC di Oncologia Medica Azienda Ospedaliero-Universitaria di Parma
        • Contact:
          • Alessandro Leonetti, MD
    • RA
      • Ravenna, RA, Italy, 48100
        • Recruiting
        • U.O.C. Oncologia Medica Azienda Unità Sanitaria Locale della Romagna
        • Contact:
          • Chiara Bennati, MD
    • RE
      • Reggio Emilia, RE, Italy, 42123
        • Active, not recruiting
        • S.C. Oncologia Provinciale, Azienda USL-IRCCS di Reggio Emilia
    • RM
      • Roma, RM, Italy, 00128
        • Not yet recruiting
        • Fondazione Policlinico Universitario Campus Bio-Medico
        • Contact:
          • Alessandro Cortellini, MD
      • Roma, RM, Italy, 00144
        • Not yet recruiting
        • Ifo-Istituto Regina Elena - Oncologia Medica 1
        • Contact:
          • Fabiana Cecere, MD
      • Roma, RM, Italy, 00168
        • Not yet recruiting
        • Fondazione Policlinico Universitario 'Agostino Gemelli' IRCCS
        • Contact:
          • Emilio Bria, MD
    • TO
      • Orbassano, TO, Italy, 10043
        • Not yet recruiting
        • AOU San Luigi Gonzaga - SSD oncologia polmonare
        • Contact:
          • Silvia Novello, MD
    • VA
      • Varese, VA, Italy, 21100
        • Not yet recruiting
        • SC Oncologia ASST Sette Laghi "Ospedale di Circolo e Fondazione Macchi "
        • Contact:
          • Francesco Grossi, MD
    • VR
      • Peschiera del Garda, VR, Italy, 37019
        • Active, not recruiting
        • "OSPEDALE P. PEDERZOLI" Casa di Cura Privata S.p.A.
      • Verona, VR, Italy, 37126
        • Not yet recruiting
        • AOU Integrata di Verona - Ospedale Borgo Trento
        • Contact:
          • Lorenzo Belluomini, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Secondary endpoint
Time Frame: 3 years
• 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
3 years
Secondary endpoint
Time Frame: 3 years
• Correlation of new variants in NGS and clinical features to the onset of recurrence (on treatment/off treatment)
3 years
Secondary endpoint
Time Frame: 3 years
• percent of treatment options at disease relapse
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gruppo Oncologico Italiano di Ricerca Clinica

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 14, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 10, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GOIRC-03-2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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