RecruitingNCT06234579

Longitudinal Assessment of Genomic Alterations and Clonal Evolution in ALK-positive NSCLC (Galileo Project)

"GALILEO (Genomic ALteratIons and cLonal EvOlution in ALK+ NSCLC) - Valutazione Longitudinale Delle Alterazioni Genomiche e Clonali Nei Pazienti Affetti da Neoplasie Polmonari ALK-riarrangiate".

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

108 participants

Start Date

Jul 12, 2021

Study Type

OBSERVATIONAL

Conditions

NSCLC Stage IV ALK Gene Mutation ALK Sensitizing Mutation

Summary

The scope of GALILEO project (Genomic ALteratIons and cLonal EvOlution in ALK+ NSCLC) is to explore the feasibility of genomic longitudinal evaluation for ALK+ NSCLC patients in Italian routine practice and provide a detailed overview of resistance mechanisms and clinical outcomes according to current standard treatments.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This observational study (called the Galileo Project) is tracking genetic changes in advanced non-small cell lung cancer (NSCLC) with an ALK gene rearrangement over time, to better understand how the cancer evolves and becomes resistant to treatment. **You may be eligible if...** - You have been diagnosed with advanced NSCLC with an ALK rearrangement (detected by genetic testing) - You have been taking alectinib, brigatinib, or lorlatinib as your first-line treatment for at least 28 days - You are 18 or older - You are in reasonably good general health **You may NOT be eligible if...** - Your lung cancer does not have an ALK rearrangement - You stopped treatment early due to side effects without any evidence of cancer progression Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTBiopsy (tissue or liquid)

At the time of diagnosis, all newly diagnosed ALK+ NSCLC patients eligible for first line treatment with alectinib or brigatinib or lorlatinib will be considered for the study. In case of progression, a multidisciplinary team (oncologists, interventional pneumologists and radiologists, surgeons) will discuss case-by-case the feasibility to procure an adequate biopsy from progressing lesions. Repeat biopsies will be performed within 2 weeks from multidisciplinary evaluation and before the start of subsequent treatment. If repeat biopsies are not technically or safely feasible or fail to yield sufficient material for genomic analysis, we will collect a whole blood drawn by venepuncture for the analysis of ctDNA.

Locations(1)

Fondazione Policlinico Gemelli IRCCS

Rome, Italy

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NCT06234579

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