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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07363252

Acronym

REMAIN

Enrollment

100

Registered

2026-01-23

Start date

2026-04-14

Completion date

2028-12-01

Last updated

2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

EGFR-mutated NSCLC

Keywords

EGFR-mutated NSCLC, adjuvant osimertinib, Recurrence

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

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.

Interventions

DRUGOsimertinib

Characterization of the molecular mechanisms of recurrence to adjuvant osimertinib

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
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	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

Secondary

Measure	Time frame	Description
Secondary endpoint	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

Countries

Italy

Contacts

CONTACTAlessandro Leonetti, MD

aleonetti@ao.pr.it+39 0521702682

CONTACTMichele Tognetto

goirc-remain@goirc.org

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026