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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• U.O.C. Oncologia Medica Azienda Unità Sanitaria Locale della Romagna
  Ravenna, Ra, Italy Recruiting
• IRCCS Oncologico Giovanni Paolo II
  Bari, Ba, Italy Active not recruiting
• Asst Papa Giovanni Xxiii Sc Oncologia
  Bergamo, Bg, Italy Not yet recruiting
• UOC di Oncologia Medica IRCCS - Policlinico S. Orsola Malpighi
  Bologna, Bo, Italy Not yet recruiting
• Humanitas Istituto Clinico Catanese Contrada Cubba
  Misterbianco, CT, Italy Not yet recruiting
• A.S.S.T - Monza Ospedale San Gerardo
  Monza, Mb, Italy Not yet recruiting

Study contacts

• Study coordinator: Alessandro Leonetti, MD
• Email: aleonetti@ao.pr.it
• Phone: +39 0521702682

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.