Clinical trial NCT06234579: Longitudinal Assessment of Genomic Alterations and Clonal Evolution in ALK-positive NSCLC (Galileo Project)
Official title: "GALILEO (Genomic ALteratIons and cLonal EvOlution in ALK+ NSCLC) - Valutazione Longitudinale Delle Alterazioni Genomiche e Clonali Nei Pazienti Affetti da Neoplasie Polmonari ALK-riarrangiate".
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: ALK Gene Mutation
NSCLC Stage IV
ALK Sensitizing Mutation
Keywords: ALK mutation
NSCLC
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with newly diagnosed ALK+ NSCLC who are candidate to receive first-line therapy with II-III genaration ALK-inhibitor (alectinib, brigatinib or lorlatinib)

Brief 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 criteria: 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a) early withdrawn of treatment due to toxicity without evidence of radiological disease progression cannot be eligible for the study

Primary outcomes:
measure: Percentage of patients with available NGS testing at diagnosis
timeFrame: 5 years
measure: Percentage of patients with available NGS re-testing after progession (either tissue or ctDNA) to first-line treatment with II-III generation ALK-Inhibitor
timeFrame: 5 years
Secondary outcomes:
measure: PFS to first-line treatment with II-III generation ALK-inhibitor
timeFrame: 5 years
measure: PFS to first-line treatment with II-III generation ALK-inhibitor
timeFrame: 5 years
Other outcomes:
measure: PFS to first-line treatment with II-III generation ALK-inhibitor
timeFrame: 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
measure: PFS to first-line treatment with II-III generation ALK-inhibitor
timeFrame: 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
measure: OS to first-line treatment with II-III generation ALK-inhibitor
timeFrame: Time from treatment start until the date of death from any cause, assessed up to 5 years
measure: OS to first-line treatment with II-III generation ALK-inhibitor
timeFrame: Time from treatment start until the date of death from any cause, assessed up to 5 years
measure: Incidence of secondary resistance mutations (SNVs) after first line treatment
timeFrame: 5 years
measure: PFS to lorlatinib according to secondary resistance mechanism
timeFrame: 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
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico Universitario A Gemelli
name: GIAMPAOLO TORTORA, Prof.
role: PRINCIPAL_INVESTIGATOR
References: