Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC

Part of paid clinical trials in Glendale, Arizona.

Sponsor
Nuvalent Inc.
Study ID
NCT06765109
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Neladalkib (NVL-655) — DRUG
    Oral tablet of Neladalkib (NVL-655)
  • Alectinib — DRUG
    Oral capsule of alectinib

Study Details

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).

Key Dates

Start date
Jul 17, 2025
Status verified
May 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Neladalkib (NVL-655)
    150mg taken orally once daily (QD)
  • Active Comparator: Alectinib
    600mg taken orally twice daily (BID)

Primary Outcome Measure

Progression-free survival (PFS) per blinded independent central review (BICR) [ Time Frame: Up to 5 years after first patient dosed ]

Central Contacts

Locations (22)

FacilityCityStateZIPSite coordinators
Palo Verde Hematology OncologyGlendaleArizona85304
Amol Nanak Singh Rakkar, M.D. (PRINCIPAL_INVESTIGATOR)
Hoag Hospital Newport BeachNewport BeachCalifornia92663
Yaser Homsi, MD (PRINCIPAL_INVESTIGATOR)
University of California, Irvine HealthOrangeCalifornia92868
Misako Nagasaka, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
Rocky Mountain Cancer CentersBoulderColorado80218
Robert Jotte, MD, PhD (PRINCIPAL_INVESTIGATOR)
Sylvester Comprehensive Cancer Center MiamiMiamiFlorida33136
Gilberto de Lima Lopes, Jr., M.D. (PRINCIPAL_INVESTIGATOR)
AdventHealth Cancer InstituteOrlandoFlorida32804
Mark Socinski, M.D. (PRINCIPAL_INVESTIGATOR)
H Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612
Ben Creelan, M.D. (PRINCIPAL_INVESTIGATOR)
Winship Cancer Institute of Emory UniversityAtlantaGeorgia30322
Ticiana Leal, M.D. (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Alice Shaw, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
Barbara Ann Karmanos Cancer InstituteDetroitMichigan48201-
Washington University Center for Advanced MedicineSt LouisMissouri63110
Ayse Ece Cali Daylan, M.D. (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Alexander Drilon, M.D. (PRINCIPAL_INVESTIGATOR)
NYU Langone's Perlmutter Cancer CenterNew YorkNew York10016
Elaine Shum, MD (PRINCIPAL_INVESTIGATOR)
Optum Medical Care, PCWestburyNew York11590
Jonathan S. Goldberg, M.D. (PRINCIPAL_INVESTIGATOR)
Carolinas Medical CenterCharlotteNorth Carolina28203
Daniel Haggstrom, MD (PRINCIPAL_INVESTIGATOR)
Duke Cancer CenterDurhamNorth Carolina27710
Thomas Stinchcombe, M.D. (PRINCIPAL_INVESTIGATOR)
University of Cincinnati Cancer CenterCincinnatiOhio45267
Jennifer Leddon, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
The Ohio State UniversityColumbusOhio43210
Logan Roof, M.D., MSCR (PRINCIPAL_INVESTIGATOR)
Alliance Cancer SpecialistsSellersvillePennsylvania18960
Howard Zipin, MD (PRINCIPAL_INVESTIGATOR)
SCRI Oncology PartnersNashvilleTennessee37203
Melissa Johnson, M.D. (PRINCIPAL_INVESTIGATOR)
Virginia Cancer SpecialistsFairfaxVirginia22031
Alexander Spira, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)
University of Washington - Fred Hutchinson Cancer CenterSeattleWashington98109
Christina Baik, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Glendale, AZ

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By research site
Palo Verde Hematology Oncology· Glendale, AZHoag Hospital Newport Beach· Newport Beach, CAUniversity of California, Irvine Health· Orange, CARocky Mountain Cancer Centers· Boulder, COSylvester Comprehensive Cancer Center Miami· Miami, FLAdventHealth Cancer Institute· Orlando, FL

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