Investigation of REcurrence Mechanisms to Adjuvant osimertINib in Radically Resected EGFR-mutated NSCLC Patients
REMAIN
1 other identifier
observational
100
1 country
25
Brief Summary
Retrospective-prospective observational multicentric study including radically resected EGFR-mutated NSCLC patients relapsed during or after adjuvant osimertinib, received according to clinical practice
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2026
Typical duration for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2025
CompletedFirst Posted
Study publicly available on registry
January 23, 2026
CompletedStudy Start
First participant enrolled
April 14, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
April 22, 2026
January 1, 2026
2.6 years
December 10, 2025
April 17, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
3 years
Secondary Outcomes (3)
Secondary endpoint
3 years
Secondary endpoint
3 years
Secondary endpoint
3 years
Interventions
Characterization of the molecular mechanisms of recurrence to adjuvant osimertinib
Eligibility Criteria
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
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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
IRCCS Oncologico Giovanni Paolo II
Bari, BA, 70124, Italy
Asst Papa Giovanni Xxiii Sc Oncologia
Bergamo, BG, 24127, Italy
UOC di Oncologia Medica IRCCS - Policlinico S. Orsola Malpighi
Bologna, BO, 40138, Italy
Humanitas Istituto Clinico Catanese Contrada Cubba
Misterbianco, CT, 95045, Italy
A.S.S.T - Monza Ospedale San Gerardo
Monza, MB, 20900, Italy
Grande Ospedale Metropolitano Niguarda Ca' Granda
Milan, Michigan, 20162, Italy
Dip Oncologia-Ematologia - UO Oncologia AOU Policlinico di Modena
Modena, Missouri, 41124, Italy
Irccs Humanitas Research Hospital
Milan, MI, 20089, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
Milan, MI, 20113, Italy
Ospedale San Raffaele Dipartimento di Oncologia Medica
Milan, MI, 20132, Italy
European Institute of Oncology IRCCS
Milan, MI, 20141, Italy
UOC di Oncologia Medica 2 - IOV Istituto Oncologico Veneto
Padova, PD, 35128, Italy
S.O.C. di Oncologia Medica e dei Tumori Immuno-correlati, Centro di Riferimento Oncologico IRCCS
Aviano, PN, 33081, Italy
UOC di Oncologia Medica Azienda Ospedaliero-Universitaria di Parma
Parma, PR, 43126, Italy
U.O.C. Oncologia Medica Azienda Unità Sanitaria Locale della Romagna
Ravenna, RA, 48100, Italy
S.C. Oncologia Provinciale, Azienda USL-IRCCS di Reggio Emilia
Reggio Emilia, RE, 42123, Italy
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, RM, 00128, Italy
Ifo-Istituto Regina Elena - Oncologia Medica 1
Roma, RM, 00144, Italy
Fondazione Policlinico Universitario 'Agostino Gemelli' IRCCS
Roma, RM, 00168, Italy
AOU San Luigi Gonzaga - SSD oncologia polmonare
Orbassano, TO, 10043, Italy
SC Oncologia ASST Sette Laghi "Ospedale di Circolo e Fondazione Macchi "
Varese, VA, 21100, Italy
"OSPEDALE P. PEDERZOLI" Casa di Cura Privata S.p.A.
Peschiera del Garda, VR, 37019, Italy
AOU Integrata di Verona - Ospedale Borgo Trento
Verona, VR, 37126, Italy
Oncologia Clinica Sperimentale Toraco-Polmonare, IRCCS Pascale di Napoli
Naples, 80131, Italy
A.O.U. "Maggiore della Carita'"- S.C.D.U Oncologia
Novara, 28100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2025
First Posted
January 23, 2026
Study Start
April 14, 2026
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
April 22, 2026
Record last verified: 2026-01