Menu
Recruiting NCT07363252

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

— Observational EGFR-mutated NSCLC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Osimertinib.
Who it may be relevant to
Registry conditions: EGFR-mutated NSCLC. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug Osimertinib
    Characterization of the molecular mechanisms of recurrence to adjuvant osimertinib

Primary outcome measures

  • 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]
Secondary outcome measures (3)
  • Secondary endpoint [Time frame: 3 years]
  • Secondary endpoint [Time frame: 3 years]
  • Secondary endpoint [Time frame: 3 years]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 25 centers
  • IRCCS Oncologico Giovanni Paolo II — Bari
  • Asst Papa Giovanni Xxiii Sc Oncologia — Bergamo
  • UOC di Oncologia Medica IRCCS - Policlinico S. Orsola Malpighi — Bologna
  • Humanitas Istituto Clinico Catanese Contrada Cubba — Misterbianco
  • A.S.S.T - Monza Ospedale San Gerardo — Monza
  • Grande Ospedale Metropolitano Niguarda Ca' Granda — Milan
  • Dip Oncologia-Ematologia - UO Oncologia AOU Policlinico di Modena — Modena
  • Irccs Humanitas Research Hospital — Milan
  • … and 17 more centers

Identifiers

NCT: NCT07363252 · GOIRC-03-2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗