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Clinical trialNCT05384626RecruitingPhase 1/PHASE2Interventional

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

SponsorNuvalent Inc.Enrollment840Locally Advanced Solid TumorMetastatic Solid Tumor
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of neladalkib (NVL-655), determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ALK- positive (ALK+) NSCLC and other solid tumors. Phase 1 will evaluate the overall safety and tolerability of neladalkib and will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of neladalkib in patients with advanced ALK+ solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of neladalkib at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of neladalkib in patients with advanced ALK-positive NSCLC and other solid tumors. A drug-drug interaction (DDI) sub-study will determine the effect of neladalkib on the pharmacokinetics of midazolam and repaglinide, as well as the effect of itraconazole on the pharmacokinetics of neladalkib, in patients with advanced ALK-positive NSCLC

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

74 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Australia
  • Royal North Shore Hospital

    Sydney, New South Wales, Australia

    Malinda Itchins, MBBS PhD
    Recruiting
  • Princess Alexandra Hospital

    Woolloongabba, Queensland, Australia

    Kenneth O'Byrne, MD
    Recruiting
  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, Australia

    Benjamin Solomon, MD, PhD
    Recruiting
Belgium
  • Universitair Ziekenhuis Antwerpen (uza)

    Antwerp, Belgium

    Reinier Wener, MD
    Recruiting
  • Universitaire Ziekenhuizen Leuven Campus Gastthuisberg

    Leuven, Belgium

    Christophe Dooms, MD
    Recruiting
Canada
  • Cross Cancer Institute

    Edmonton, Alberta, Canada

    Quincy Siu Chung Chu, MD
    Recruiting
  • Bc Cancer Center

    Vancouver, British Columbia, Canada

    Barbara Melosky, MD
    Recruiting
  • the Ottawa Hospital Cancer Center

    Ottawa, Ontario, Canada

    Garth Nicholas, MD
    Recruiting
  • Princess Margaret Cancer Centre

    Toronto, Ontario, Canada

    Geoffrey Liu, M.D.
    Recruiting
France
  • Centre Leon Berard

    Lyon, France

    Aurelie Swalduz, MD
    Recruiting
  • Chu de Nantes

    Nantes, France

    Elvire Pons-Tostivint, MD, PhD
    Recruiting
  • Institut Claudius Regaud

    Toulouse, France

    Julien Mazieres, MD, PhD
    Recruiting
  • Institute Gustave Roussy

    Villejuif, France

    Benjamin Besse, MD, PhD
    Recruiting
Germany
  • Universitatsklinikum Koln - University Hospital Cologne

    Cologne, Germany

    Dr med Sebastian Michels
    Recruiting
  • Universitätsklinikum Frankfurt

    Frankfurt, Germany

    Martin Sebastian, MD
    Recruiting
  • Lungenclinic Grosshansdorf Gmbh

    Großhansdorf, Germany

    Prof Dr Martin Reck
    Recruiting
  • Universkitatsklinikum Heidelberg - University Hospital Heidelberg

    Heidelberg, Germany

    Prof Dr med Petros Christopoulos
    Recruiting
Italy
  • Azienda Ospedaliera Universitaria Ospedali Riuniti Umberto

    Ancona, Italy

    Rossana Berardi, MD
    Recruiting
  • Irccs Istituto Tumori "g. Paolo Ii"

    Bari, Italy

    Domenico Galetta, MD
    Recruiting
  • Fondazione Irccs Istituto Nazionale Dei Tumori

    Milan, Italy

    Sara Cresta, MD
    Recruiting
  • Instituto Europeo Di Oncologia

    Milan, Italy

    Gianluca Spitaleri, MD
    Recruiting
  • Instituto Oncologico Veneto

    Padova, Italy

    Giulia Pasello, MD
    Recruiting
  • Ospedale Santa Maria Delle Croci

    Ravenna, Italy

    Chiara Bennati, MD
    Recruiting
  • Regina Elena Institute for Cancer Research

    Rome, Italy

    Lorenza Landi, MD
    Recruiting
Japan
  • Kanagawa Cancer Center

    Kanagawa, Japan

    Tetsuro Kondo, MD
    Recruiting
  • Okayama University Hospital

    Okayama, Japan

    Kiichiro Ninomiya, MD
    Recruiting
  • Kindai University Hospital

    Osaka, Japan

    Junko Tanizaki, MD
    Recruiting
  • Shizuoka Cancer Center

    Shizuoka, Japan

    Ryo Ko, MD PhD
    Recruiting
  • Cancer Institute Hospital of Jfcr

    Tokyo, Japan

    Ryo Ariyasu, MD
    Recruiting
  • National Cancer Center Hospital

    Tokyo, Japan

    Tatsuya Yoshida, MD
    Recruiting
  • Wakayama Medical University Hospital

    Wakayama, Japan

    Hiroaki Akamatsu, MD, PhD
    Recruiting
Netherlands
  • the Netherlands Cancer Institute

    Amsterdam, Netherlands

    Adrianus Joop de Langen, MD
    Recruiting
  • University Medical Center Groningen (umcg)

    Groningen, Netherlands

    AJ Van Der Wekken, MD
    Recruiting
Singapore
  • National Cancer Centre Singapore

    Singapore, Singapore, Singapore

    Aaron Tan, MD
    Recruiting
  • National University Hospital

    Singapore, Singapore, Singapore

    Ross Soo, MD
    Recruiting
South Korea
  • National Cancer Center

    Goyang-si, Gyeonggi-do, South Korea

    Ji-Youn Han, MD
    Recruiting
  • Samsung Medical Center

    Seoul, South Korea

    Myung-Ju Ahn, MD
    Recruiting
  • Seoul National University Hospital

    Seoul, South Korea

    Dong-wan Kim, MD
    Recruiting
  • Severance Hospital Yonsei University Health System

    Seoul, South Korea

    Byoung Chul Cho, MD
    Recruiting
Spain
  • Complejo Hospitalario Universitario de A Coruna

    A Coruña, Spain

    Maria Campelo, MD
    Recruiting
34 more sites on the registry record.ClinicalTrials.gov ↗

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
9 Jun 2022
Primary completion
31 Dec 2027
Completion
31 Jan 2028
Last update posted
27 May 2026
Registered enrollment
840
Registry id
NCT05384626

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.