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Reasons for recurrence after adjuvant osimertinib in surgically removed EGFR-mutated lung cancer

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

Observational Gruppo Oncologico Italiano di Ricerca Clinica · NCT07363252

This project looks for genetic and clinical reasons why people with EGFR-mutated lung cancer who had surgery and adjuvant osimertinib later had their cancer come back, using tissue and blood samples taken at recurrence.

Quick facts

Study typeObservational
Enrollment100 (estimated)
Ages18 Years and up
SexAll
SponsorGruppo Oncologico Italiano di Ricerca Clinica Academic / other
Drugs / interventionsosimertinib
Locations25 sites (Bari, BA and 24 other locations)
Trial IDNCT07363252 on ClinicalTrials.gov

What this trial studies

This is a multicenter retrospective-prospective observational study of adults with radically resected stage IB-IIIA EGFR-mutated non-small cell lung cancer who received adjuvant osimertinib and subsequently relapsed either during treatment or after stopping it. Clinical data including demographics, comorbidities, and treatment outcomes will be collected for each patient. Centrally performed next-generation sequencing (NGS) will analyze tissue and/or liquid biopsies obtained at the time of recurrence, and NGS will also be run on surgical tissue where available. Patients may be enrolled at or after the time of recurrence and samples from participating Italian centers will be processed centrally for molecular profiling.

Who should consider this trial

Good fit: Adults (≥18) with radically resected stage IB–IIIA EGFR-activating mutation NSCLC who received adjuvant osimertinib and experienced relapse during or after that therapy, and who have a tissue and/or liquid biopsy from the time of recurrence and can give consent.

Not a fit: Patients without an available tissue or liquid biopsy at recurrence, with concurrent active non-NSCLC malignancies treated within the past two years, or who never received adjuvant osimertinib are unlikely to benefit from this project.

Why it matters

Potential benefit: If successful, the study could identify common resistance mechanisms after adjuvant osimertinib that help doctors choose better follow-up therapies and design future trials.

How similar studies have performed: Prior molecular studies in advanced EGFR-mutant NSCLC have identified both EGFR-dependent and EGFR-independent resistance mechanisms to osimertinib, but comprehensive NGS profiling specifically at adjuvant recurrence remains limited.

Eligibility criteria

Show full inclusion / 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).

Where this trial is running

Bari, BA and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions EGFR-mutated NSCLCadjuvant osimertinibRecurrence
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.