An observational study in EGFR-mutated NSCLC, sponsored by Gruppo Oncologico Italiano di Ricerca Clinica. Recruiting at 25 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-22.
Sponsored by Gruppo Oncologico Italiano di Ricerca Clinica · Observational
Retrospective-prospective observational multicentric study including radically resected EGFR-mutated NSCLC patients relapsed during or after adjuvant osimertinib, received according to clinical practice
This study will include patients
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.
Gruppo Oncologico Italiano di Ricerca Clinica is the lead sponsor of 28 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
100 relapsed EGFR-mutated NSCLC patient receiving osimertinib in adjuvant setting and with tissue biopsy and/or liquid biopsy collected at the time of recurrence
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Characterization of the molecular mechanisms of recurrence to adjuvant osimertinib
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
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 endpoint
• Frequency of new variant(s) in Next Generation Sequencing (NGS) Panel in tissue sample at the time of recurrence to adjuvant osimertinib compared to surgical/pre-osimertinib sample
Time frame: 3 years
Secondary endpoint
• percent of treatment options at disease relapse
Time frame: 3 years
Secondary endpoint
• Correlation of new variants in NGS and clinical features to the onset of recurrence (on treatment/off treatment)
Time frame: 3 years
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Started Apr 2026 (actual). Primary completion is estimated for Dec 2028, 32 months after the start.
How these figures are worked out, and which studies are left out of them.
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Gruppo Oncologico Italiano di Ricerca Clinica