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

Gruppo Oncologico Italiano di Ricerca Clinica

Status: Not yet enrolling

Conditions: EGFR-mutated NSCLC

Treatments: Drug: Osimertinib

Study type: Observational

Funder types: Other

Identifiers

NCT07363252

GOIRC-03-2024

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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).