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BChir, Ph.D.",{"facility":1842,"status":44,"city":1843,"state":25,"zip":1844,"country":1807,"countryCode":1808,"cosmosGeoPoint":1845,"geoPoint":1849,"contacts":1850},"Guy's Cancer Centre NHS Foundation Trust","London","SE1 9RT",{"type":51,"coordinates":1846},[1847,1848],-0.12574,51.50853,{"lat":1848,"lon":1847},[1851],{"name":1852,"role":59,"phone":25,"phoneExt":25,"email":25},"Sharmistha Ghosh, BMBCH",{"facility":1854,"status":44,"city":1843,"state":25,"zip":1855,"country":1807,"countryCode":1808,"cosmosGeoPoint":1856,"geoPoint":1858,"contacts":1859},"The Royal Marsden NHS Foundation Trust","SW3 6JJ",{"type":51,"coordinates":1857},[1847,1848],{"lat":1848,"lon":1847},[1860],{"name":1861,"role":59,"phone":25,"phoneExt":25,"email":25},"Sanjay Popat, MBBS, Ph.D.",{"facility":1863,"status":44,"city":1864,"state":25,"zip":1865,"country":1807,"countryCode":1808,"cosmosGeoPoint":1866,"geoPoint":1870,"contacts":1871},"Maidstone Hospital","Maidstone","ME16 9QQ",{"type":51,"coordinates":1867},[1868,1869],0.51667,51.26667,{"lat":1869,"lon":1868},[1872],{"name":1873,"role":59,"phone":25,"phoneExt":25,"email":25},"Riyaz Shah, MBBS, Ph.D.",{"facility":1875,"status":44,"city":1876,"state":25,"zip":1877,"country":1807,"countryCode":1808,"cosmosGeoPoint":1878,"geoPoint":1882,"contacts":1883},"The Christie NHS Foundation Trust","Manchester","M20 4BX",{"type":51,"coordinates":1879},[1880,1881],-2.23743,53.48095,{"lat":1881,"lon":1880},[1884],{"name":1885,"role":59,"phone":25,"phoneExt":25,"email":25},"Raffaele Califano, M.D.",{"facility":1887,"status":44,"city":1888,"state":25,"zip":1806,"country":1807,"countryCode":1808,"cosmosGeoPoint":1889,"geoPoint":1893,"contacts":1894},"Nottingham City Hospital","Nottingham",{"type":51,"coordinates":1890},[1891,1892],-1.15047,52.9536,{"lat":1892,"lon":1891},[1895],{"name":1896,"role":59,"phone":25,"phoneExt":25,"email":25},"Jason Adhikaree, MBBS, Ph.D.",{"type":1898,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100574886",false,"NCT06765109","Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC","A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)","ALKAZAR","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC)\n2. Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood\n3. No prior systemic anticancer treatment for NSCLC (adjuvant\u002Fneoadjuvant chemotherapy allowed if 12 months prior to randomization; prior ALK tyrosine kinase inhibitor \\[TKI\\] such as alectinib is not allowed in any setting)\n4. Measurable disease (1 or more target lesions per Response Evaluation Criteria in Solid Tumors \\[RECIST\\] 1.1)\n5. Pretreatment tumor tissue\n\nExclusion Criteria:\n\n1. Patient's cancer has a known oncogenic driver alteration other than ALK.\n2. Known allergy\u002Fhypersensitivity to excipients of neladalkib or alectinib.\n3. Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization\n4. Major surgery within 4 weeks prior to randomization\n5. Uncontrolled clinically relevant infection requiring systemic therapy\n6. Known active tuberculosis, or active Hepatitis B or C\n7. QT corrected for heart rate by Fridericia's formula (QTcF) \\> 470 msec on repeated assessments\n8. Clinically significant cardiovascular disease\n9. Brain metastases associated with progressive neurological symptoms or requiring increasing doses of corticosteroids to control CNS disease\n10. Active malignancy requiring therapy within 2 years prior to randomization","ALL","18 Years",{"count":1909,"type":1910},450,"ESTIMATED","INTERVENTIONAL",[1913],"PHASE3","Multicenter, randomized, controlled, open-label, Phase 3 study designed to demonstrate that neladalkib (NVL-655) is superior to alectinib in prolonging progression-free survival (PFS) in patients with treatment-naïve, Anaplastic Lymphoma Kinase (ALK) positive, advanced Non-Small Cell Lung Cancer (NSCLC).",[1916,1917],"Non-small Cell Lung Cancer","Anaplastic Lymphoma Kinase-positive",[1919,1920,1921,1922,1923,1924,1925,1926],"NSCLC","Lung cancer","Lung neoplasms","Lung diseases","ALK positive NSCLC","TKI naive","ALK TKI naive","Treatment naive","2026-05-29",{"date":1929,"type":1930},"2026-06-02","ACTUAL",{"date":1932,"type":1930},"2025-07-17",{"date":1934,"type":1910},"2029-12",{"name":5,"class":6},155]