A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

840

Participants

Timeline

Start Date

June 9, 2022

Primary Completion Date

December 31, 2027

Study Completion Date

January 31, 2028

Conditions
Locally Advanced Solid TumorMetastatic Solid Tumor
Interventions
DRUG

Neladalkib (NVL-655)

Oral Tablet of Neladalkib (NVL-655)

Trial Locations (74)

2065

RECRUITING

Royal North Shore Hospital, Sydney

2650

RECRUITING

Universitair Ziekenhuis Antwerpen (UZA), Antwerp

3000

RECRUITING

Peter MacCallum Cancer Centre, Melbourne

RECRUITING

Universitaire Ziekenhuizen Leuven Campus Gastthuisberg, Leuven

4102

RECRUITING

Princess Alexandra Hospital, Woolloongabba

6000

RECRUITING

Luzerner Kantonsspital, Lucerne

6500

RECRUITING

Istituto Oncologico Svizzera Italiana, Bellinzona

10002

RECRUITING

National Taiwan University Hospital, Taipei

10016

RECRUITING

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health, New York

10065

RECRUITING

Memorial Sloan Kettering Cancer Center, New York

10408

RECRUITING

National Cancer Center, Goyang-si

15006

RECRUITING

Complejo Hospitalario Universitario de A Coruna, A Coruña

19104

RECRUITING

University of Pennsylvania, Abramson Cancer Center, Philadelphia

20007

RECRUITING

Georgetown University Medical Center, Washington D.C.

20133

RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

20141

RECRUITING

Instituto Europeo di Oncologia, Milan

21224

RECRUITING

John Hopkins University, Baltimore

22927

RECRUITING

LungenClinic Grosshansdorf GmbH, Großhansdorf

27705

RECRUITING

Duke University Medical Center, Durham

28009

RECRUITING

Hospital General Universitario Gregorio Maranon, Madrid

28041

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

30322

RECRUITING

Winship Cancer Institute, Emory University, Atlanta

31059

RECRUITING

Institut Claudius Regaud, Toulouse

33136

RECRUITING

University of Miami; Sylvester Cancer Center, Miami

35128

RECRUITING

Instituto Oncologico Veneto, Padua

37203

RECRUITING

Sarah Cannon, Nashville

43210

RECRUITING

OSU Brain & Spine Hospital, Columbus

44093

RECRUITING

Chu De Nantes, Nantes

48100

RECRUITING

Ospedale Santa Maria delle Croci, Ravenna

48202

RECRUITING

Henry Ford Cancer Institute, Detroit

50937

RECRUITING

Universitatsklinikum Koln - University Hospital Cologne, Cologne

60126

RECRUITING

Azienda Ospedaliera Universitaria Ospedali Riuniti Umberto, Ancona

60590

RECRUITING

Universitätsklinikum Frankfurt, Frankfurt

60637

RECRUITING

University of Chicago Medical Center, Chicago

63310

RECRUITING

Washington University School of Medicine Siteman Cancer Center, St Louis

69126

RECRUITING

Universkitatsklinikum Heidelberg - University Hospital Heidelberg, Heidelberg

69373

RECRUITING

Centre Leon Berard, Lyon

70124

RECRUITING

"IRCCS Istituto Tumori G. Paolo II", Bari

70403

RECRUITING

National Cheng Kung University Hospital, Tainan City

77030

ACTIVE_NOT_RECRUITING

MD Anderson Cancer Center, Houston

80045

RECRUITING

University of Colorado Cancer Center, Aurora

92868

RECRUITING

University of California Irvine Medical Center, Orange

94305

RECRUITING

Stanford Cancer Institute, Stanford

94805

RECRUITING

Institute Gustave Roussy, Villejuif

95817

RECRUITING

University of California, Davis Comprehensive Cancer Center, Sacramento

98109

RECRUITING

Fred Hutchinson Cancer Center, Seattle

119074

RECRUITING

National University Hospital, Singapore

168583

RECRUITING

National Cancer Centre Singapore, Singapore

402306

RECRUITING

Chung-Shan Medical University Hospital, Taichung

1040051

RECRUITING

National Cancer Center Hospital, Tokyo

1358550

RECRUITING

Center Institute Hospital of JFCR, Tokyo

2418515

RECRUITING

Kanagawa Cancer Center, Kanagawa

4118777

RECRUITING

Shizuoka Cancer Center, Shizuoka

5898511

RECRUITING

Kindai University Hospital, Osaka

6418510

RECRUITING

Wakayama Medical University Hospital, Wakayama

7008558

RECRUITING

Okayama University Hospital, Okayama

02114

RECRUITING

Massachusetts General Hospital, Boston

02215

RECRUITING

Dana Farber Cancer Institute, Boston

T6G 1Z2

RECRUITING

Cross Cancer Institute, Edmonton

VZ 4E6

RECRUITING

BC Cancer Center, Vancouver

K1H 8L6

RECRUITING

The Ottawa Hospital Cancer Center, Ottawa

M5G 0A3

RECRUITING

Princess Margaret Cancer Centre, Toronto

00144

RECRUITING

Regina Elena Institute for Cancer Research, Rome

1066 CX

RECRUITING

The Netherlands Cancer Institute, Amsterdam

9713 GZ

RECRUITING

University Medical Center Groningen (UMCG), Groningen

03080

RECRUITING

Seoul National University Hospital, Seoul

03722

RECRUITING

Severance Hospital Yonsei University Health System, Seoul

06351

RECRUITING

Samsung Medical Center, Seoul

08017

RECRUITING

UOMI Cancer Center, Barcelona

08035

RECRUITING

Vall d'Hebron, Barcelona

SM2 5PT

RECRUITING

Royal Marsden Hospital, Sutton

RECRUITING

The Royal Marsden - Chelsea, London

EH4 2XU

RECRUITING

Edinburgh Cancer Centre, Edinburgh

M20 4BX

RECRUITING

The Christie NHS Foundation Trust, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Nuvalent Inc.

INDUSTRY

NCT05384626 - A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1) | Biotech Hunter | Biotech Hunter