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

Recruiting

Conditions

Intervention / Treatment

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

Observational

Enrollment (Estimated)

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 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

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

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

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

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)

April 14, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

December 10, 2025

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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