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

NCT06234579 | Recruiting FDA Drug

• 1 other identifier: 4906
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

ALK Gene Mutation; NSCLC Stage IV; ALK Sensitizing Mutation

Keywords

ALK mutation; NSCLC

Outcome Measures

Primary Outcomes (2)

• Percentage of patients with available NGS testing at diagnosis

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

  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

  5 years

Secondary Outcomes (2)

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

  5 years

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

  5 years

Other Outcomes (6)

• 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

• 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

• OS to first-line treatment with II-III generation ALK-inhibitor

  Time from treatment start until the date of death from any cause, assessed up to 5 years

Study Arms (1)

ALK+ NSCLC

The GALILEO project is an Italian observational prospective cohort study on advanced ALK+ NSCLC patient progressing on first-line therapy with alectinib

Diagnostic Test: Biopsy (tissue or liquid)

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.

Also known as: Alectinib, Brigatinib, Lorlatinib

ALK+ NSCLC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Gemelli IRCCS

Rome, 00168, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Biopsy; Histocompatibility Testing

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Immunologic Tests; Immunologic Techniques

Study Officials

• GIAMPAOLO TORTORA, Prof.

  Fondazione Policlinico Universitario A Gemelli

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emanuele Vita, MD

CONTACT

3480510228; dr.emanuele.vita@gmail.com

EMILIO Bria, Prof.

CONTACT

0630156318; emilio.bria@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: January 31, 2024
• Study Start: July 12, 2021
• Primary Completion: March 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)