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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALK+ NSCLC | The GALILEO project is an Italian observational prospective cohort study on advanced ALK+ NSCLC patient progressing on first-line therapy with alectinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5 years |
| PFS to first-line treatment with II-III generation ALK-inhibitor |
| Measure | Description | Time Frame |
|---|---|---|
| PFS to first-line treatment with II-III generation ALK-inhibitor | PFS to first-line, stratified according to ALK-rearrangement variants | 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 |
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
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Patients with newly diagnosed ALK+ NSCLC who are candidate to receive first-line therapy with II-III genaration ALK-inhibitor (alectinib, brigatinib or lorlatinib)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emanuele Vita, MD | Contact | 3480510228 | dr.emanuele.vita@gmail.com | |
| EMILIO Bria, Prof. | Contact | 0630156318 | emilio.bria@policlinicogemelli.it |
| Name | Affiliation | Role |
|---|---|---|
| GIAMPAOLO TORTORA, Prof. | Fondazione Policlinico Universitario A Gemelli | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Gemelli IRCCS | Recruiting | Rome | 00168 | Italy |
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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.
|
|
Time from treatment start to death for any cause, assesed up to 5 years |
| 5 years |
PFS to first-line, stratified according to NGS-based mutational profiling |
| 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 | OS to first-line, stratified according to ALK-rearrangement variants | Time from treatment start until the date of death from any cause, assessed up to 5 years |
| OS to first-line treatment with II-III generation ALK-inhibitor | OS to first-line, stratified according to NGS-based mutation profiling | Time from treatment start until the date of death from any cause, assessed up to 5 years |
| Incidence of secondary resistance mutations (SNVs) after first line treatment | Percentage of patients with SNV-based resistance diagnosed by tissue or liquid biopsy | 5 years |
| PFS to lorlatinib according to secondary resistance mechanism | PFS to second-line lorlatinib, stratified according to type of resistance (SNV vs off-target) | 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 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| D006650 | Histocompatibility Testing |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D007159 | Immunologic Tests |
| D007158 | Immunologic Techniques |
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