RecruitingNCT07363252

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

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


Sponsor

Gruppo Oncologico Italiano di Ricerca Clinica

Enrollment

100 participants

Start Date

Apr 14, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria6

  • 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 Criteria3

  • 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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Interventions

DRUGOsimertinib

Characterization of the molecular mechanisms of recurrence to adjuvant osimertinib


Locations(25)

IRCCS Oncologico Giovanni Paolo II

Bari, BA, Italy

Asst Papa Giovanni Xxiii Sc Oncologia

Bergamo, BG, Italy

UOC di Oncologia Medica IRCCS - Policlinico S. Orsola Malpighi

Bologna, BO, Italy

Humanitas Istituto Clinico Catanese Contrada Cubba

Misterbianco, CT, Italy

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

Monza, MB, Italy

Grande Ospedale Metropolitano Niguarda Ca' Granda

Milan, Michigan, Italy

Dip Oncologia-Ematologia - UO Oncologia AOU Policlinico di Modena

Modena, Missouri, Italy

Irccs Humanitas Research Hospital

Milan, MI, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Milan, MI, Italy

Ospedale San Raffaele Dipartimento di Oncologia Medica

Milan, MI, Italy

European Institute of Oncology IRCCS

Milan, MI, Italy

UOC di Oncologia Medica 2 - IOV Istituto Oncologico Veneto

Padova, PD, Italy

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

Aviano, PN, Italy

UOC di Oncologia Medica Azienda Ospedaliero-Universitaria di Parma

Parma, PR, Italy

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

Ravenna, RA, Italy

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

Reggio Emilia, RE, Italy

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, RM, Italy

Ifo-Istituto Regina Elena - Oncologia Medica 1

Roma, RM, Italy

Fondazione Policlinico Universitario 'Agostino Gemelli' IRCCS

Roma, RM, Italy

AOU San Luigi Gonzaga - SSD oncologia polmonare

Orbassano, TO, Italy

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

Varese, VA, Italy

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

Peschiera del Garda, VR, Italy

AOU Integrata di Verona - Ospedale Borgo Trento

Verona, VR, Italy

Oncologia Clinica Sperimentale Toraco-Polmonare, IRCCS Pascale di Napoli

Naples, Italy

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

Novara, Italy

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