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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS108 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

108

Conditions

ALK Gene Mutation NSCLC Stage IV ALK Sensitizing Mutation

Interventions

Biopsy (tissue or liquid)DIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * a) histologically confirmed diagnosis of advanced NSCLC with ALK rearrangement detection by NGS (ALK+ NSCLCs patients detected at diagnosis by in hybridization (FISH), immunohistochememistry (IHC), or reverse transcriptase-PCR (RT-PCR) can be included if adequate tissue for NGS is available) b) to have received upfront treatment with alectinib, brigatinib or lorlatinib for at least 28 days c) ECOG PS 0-2 d) adult patients (aged ≥ 18 years) at the moment of diagnosis e) signing of informed consent approved by the local Ethic Committee Exclusion Criteria: a) Diagnosis of lung cancer without ALK rearrangement a) early withdrawn of treatment due to toxicity without evidence of radiological disease progression cannot be eligible for the study

Outcomes

Primary Outcomes

Percentage of patients with available NGS testing at diagnosis

Percentage of ALK+ patients with adeguate tissue for NGS after diagnosisc biopsy

Time frame: 5 years

Percentage of patients with available NGS re-testing after progession (either tissue or ctDNA) to first-line treatment with II-III generation ALK-Inhibitor

Percentage of patients who obtenied successfull NGS post-progression testing after re-biopsy or liquid biopsy

Time frame: 5 years

Secondary Outcomes

PFS to first-line treatment with II-III generation ALK-inhibitor

Time from treatment start until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

Time frame: 5 years

PFS to first-line treatment with II-III generation ALK-inhibitor

Time from treatment start to death for any cause, assesed up to 5 years

Time frame: 5 years

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts