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

PHASE3RecruitingINTERVENTIONAL
Enrollment

450

Participants

Timeline

Start Date

July 17, 2025

Primary Completion Date

December 31, 2029

Study Completion Date

December 31, 2029

Conditions
Non-small Cell Lung CancerAnaplastic Lymphoma Kinase-positive
Interventions
DRUG

Neladalkib (NVL-655)

Oral tablet of Neladalkib (NVL-655)

DRUG

Alectinib

Oral capsule of alectinib

Trial Locations (32)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

10408

RECRUITING

Center for Lung Cancer, National Cancer Center, Goyang-si

10450

RECRUITING

Hospital Pulau Pinang, George Town

11042

RECRUITING

Clinical Research Alliance Inc., New Hyde Park

21565

RECRUITING

Gachon University Gil Medical Center, Incheon

22031

RECRUITING

Virginia Cancer Specialists, Fairfax

28644

RECRUITING

Chungbuk National University Hospital, Cheongju-si

30322

RECRUITING

Winship Cancer Institute of Emory University, Atlanta

32804

RECRUITING

AdventHealth Cancer Institute, Orlando

37203

RECRUITING

SCRI Oncology Partners, Nashville

40201

RECRUITING

Chung Shan Medical University, Taichung

45267

RECRUITING

University of Cincinnati Cancer Center, Cincinnati

46050

RECRUITING

Beacon International Specialist Centre, Petaling Jaya

48201

RECRUITING

Barbara Ann Karmanos Cancer Institute, Detroit

50586

RECRUITING

Hospital Kuala Lumpur, Kuala Lumpur

62250

RECRUITING

Institut Kanser Negara, Putrajaya

63110

RECRUITING

Washington University Center for Advanced Medicine, St Louis

70403

RECRUITING

National Cheng Kung University Hospital, Tainan City

80218

RECRUITING

Rocky Mountain Cancer Centers, Denver

80756

RECRUITING

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

85304

RECRUITING

Palo Verde Hematology Oncology, Glendale

92868

RECRUITING

University of California, Irvine Health, Orange

93586

RECRUITING

Hospital Umum Sarawak, Kuching

168583

RECRUITING

National Cancer Centre Singapore, Singapore

308433

RECRUITING

Tan Tock Seng Hospital, Singapore

02215

RECRUITING

Dana-Farber Cancer Institute, Boston

03080

RECRUITING

Seoul National University Hospital, Seoul

03722

RECRUITING

Severance Hospital Yonsei Cancer Center, Seoul

Unknown

RECRUITING

National Taiwan University Hospital, Taipei

NG5 1PB

RECRUITING

Cambridge University Hospitals NHS Trust, Addenbrooke's Hospital, Cambridge

SE1 9RT

RECRUITING

Guy's Cancer Centre NHS Foundation Trust, London

SW3 6JJ

RECRUITING

The Royal Marsden NHS Foundation Trust, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Nuvalent Inc.

INDUSTRY