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)
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)
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).
Patients will be randomized in a 1:1 ratio (approximately 225 in each arm) to receive either neladalkib (NVL-655) or alectinib.
Inclusion Criteria:
Exclusion Criteria:
clinicaltrials@nuvalent.com857-357-7000
Glendale, Arizona 85304, United States
Seattle, Washington 98109, United States
Porto Alegre, 90610, Brazil
São José do Rio Preto, 15090, Brazil
Meldola, 47014, Italy
Roma, 00144, Italy
Nagaizumi-chō, 411-0934, Japan
Tokyo, 135-8550, Japan
Amsterdam, 1066 CX, Netherlands
Porto, 4200-072, Portugal
Cambridge, NG5 1PB, United Kingdom