NCT07363252

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: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Gruppo Oncologico Italiano di Ricerca Clinica · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• EGFR-mutated NSCLC

Interventions

Type	Name	Description
DRUG	Osimertinib	Characterization of the molecular mechanisms of recurrence to adjuvant osimertinib

Timeline

• Start date: 2026-02-01
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2026-01-23
• Last updated: 2026-02-17

Locations

25 sites across 1 country: Italy

Regulatory

• FDA-regulated drug study