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

Recruiting now

Conditions studied: EGFR-mutated NSCLC

In brief

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

Key facts

Study ID

NCT07363252

Run by

Gruppo Oncologico Italiano di Ricerca Clinica

People needed

100

Starts

2026-04-14

Expected to finish

2028-12-01

Last updated by the study team

2026-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

Where it is running

• U.O.C. Oncologia Medica Azienda Unità Sanitaria Locale della Romagna — Ravenna, RA, Italy (enrolling)
• 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
• 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
• IRCCS Oncologico Giovanni Paolo II — Bari, BA, Italy
• A.O.U. "Maggiore della Carita'"- S.C.D.U Oncologia — Novara, Italy

Full record on ClinicalTrials.gov

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