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

RecruitingOBSERVATIONAL
Enrollment

108

Participants

Timeline

Start Date

July 12, 2021

Primary Completion Date

March 31, 2026

Study Completion Date

July 31, 2026

Conditions
ALK Gene MutationNSCLC Stage IVALK Sensitizing Mutation
Interventions
DIAGNOSTIC_TEST

Biopsy (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."

Trial Locations (1)

00168

RECRUITING

Fondazione Policlinico Gemelli IRCCS, Rome

All Listed Sponsors
lead

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER