Clinical trial • Phase III • Oncology

NVL-655 (neladalkib) for Advanced ALK-positive non-small cell lung cancer

Phase III trial of NVL-655 (neladalkib) for Advanced ALK-positive non-small cell lung cancer.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Advanced ALK-positive non-small cell lung cancer
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
14-02-2025
First CTIS Authorization Date
02-06-2025

Trial design

Randomised, open-label, alecensa 150 mg hard capsules (alectinib) - marketed comparator product (productname: alecensa 150 mg hard capsules; active substance: alectinib hydrochloride; product lists maxdailydoseamount: 1200 mg). specific dosing schedule in the protocol is not provided in the public record.-controlled Phase III trial in Italy, Germany, Austria and others.

Randomised
Yes
Open Label
Yes
Comparator
Alecensa 150 mg hard capsules (alectinib) - marketed comparator product (productName: Alecensa 150 mg hard capsules; active substance: alectinib hydrochloride; product lists maxDailyDoseAmount: 1200 mg). Specific dosing schedule in the protocol is not provided in the public record.
Target Sample Size
159
Trial Duration For Participant
1575

Stratification factors

  • Brain metastases (yes vs. no)
  • Ethnic origin (Asian vs. non-Asian)
  • ECOG PS score

Eligibility

Recruits 159 Vulnerable population is selected in the trial record. Subject information and informed consent forms are provided (Main ICF and country-specific ICFs). There are specific ICF documents referenced for pregnancy and for partner/newborn in multiple countries. Assent or age-specific consent handling details are not specified in the available record..

Vulnerable Population
Vulnerable population is selected in the trial record. Subject information and informed consent forms are provided (Main ICF and country-specific ICFs). There are specific ICF documents referenced for pregnancy and for partner/newborn in multiple countries. Assent or age-specific consent handling details are not specified in the available record.

Inclusion criteria

  • {"criterion_text":"- Patients must meet all of the following criteria to be eligible to enroll in the study: 1. Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC)\n- 2. Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood\n- 3. No prior systemic anticancer treatment for NSCLC (adjuvant/neoadjuvant chemotherapy allowed if 12 months prior to randomization; prior ALK tyrosine kinase inhibitor [TKI] such as alectinib is not allowed in any setting)\n- 4. Measurable disease (1 or more target lesions per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1)\n- 5. Pretreatment tumor tissue (archived or a fresh biopsy)"}

Exclusion criteria

  • {"criterion_text":"- 1. Patient’s cancer has a known oncogenic driver alteration other than ALK.\n- 2. Known allergy/hypersensitivity to excipients of NVL-655 or alectinib.\n- 3. Major surgery within 4 weeks prior to randomization\n- 4. Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization\n- 5. Uncontrolled clinically relevant infection requiring systemic therapy\n- 6. Known active tuberculosis, known active Hepatitis B or C\n- 7. QT corrected for heart rate by Fridericia’s formula (QTcF) > 470 msec on repeated assessments\n- 8. Clinically significant cardiovascular disease\n- 9. Brain metastases associated with progressive neurological symptoms or requiring increasing doses of corticosteroids to control CNS disease\n- 10. Active malignancy requiring therapy within 2 years prior to randomization"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Progression-free survival (PFS)","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Overall survival (OS)\n- Progression-free survival (PFS) per investigator assessment\n- Time to intracranial progression per blinded independent central review (BICR)\n- Intracranial objective response rate (IC-ORR)\n- Intracranial duration of response (IC-DOR)\n- Objective response rate (ORR)\n- Duration of response (DOR)\n- Incidence and severity of treatment-emergent adverse events (TEAEs) and changes in clinically relevant laboratory parameters\n- Changes in patient-reported outcomes (PROs)","definition_or_measurement_approach":"PFS (secondary listing) specified as per investigator assessment for one measure; time to intracranial progression specified to be assessed per blinded independent central review (BICR); safety assessed by incidence and severity of TEAEs and clinically relevant laboratory parameter changes; PROs measured by patient-reported outcome instruments (quality of life questionnaires referenced in protocol documents)."}

Recruitment

Digital Remote Recruitment
Yes
Planned Sample Size
159
Recruitment Window Months
54
Consent Approach
Informed consent is obtained using Main ICF documents and country-specific ICFs (Main ICF versions listed for multiple countries). Additional ICFs are provided for pregnancy, treatment beyond progression, optional future research/genetic research, and partner/newborn where applicable. ICFs are available in country languages (examples: Italian, German, Spanish, Polish, Dutch/English for NL, Czech, French, Portuguese, Greek, Hungarian, Danish). Specific assent procedures for minors are not specified in the available documentation.

Methods

  • Physician referral letters (country-specific physician referral letters provided)
  • GP letters (GP/primary care letters for selected countries)
  • Patient brochures (digital and print versions available in multiple languages)
  • Site flyers (digital site flyers for sites to display/reach potential participants)
  • Country-specific recruitment/informed consent procedures (K1/K2 documents listed for each Member State)

Geography

Total Number Of Sites
71
Total Number Of Participants
291

Italy

Earliest CTIS Part Ii Submission Date
26-02-2025
Latest Decision Or Authorization Date
12-11-2025
Processing Time Days
259
Number Of Sites
13
Number Of Participants
65

Sites

Site Name
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Department Name
Oncologia Medica
Contact Person Name
Vanesa Gregorc
Contact Person Email
vanesa.gregorc@ircc.it
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
S.C.Oncologia Medica
Contact Person Name
Diego Cortinovis
Contact Person Email
d.cortinovis@asst-monza.it
Site Name
Istituto Tumori Bari Giovanni Paolo II
Department Name
Oncologia Medica Toracica
Contact Person Name
Domenico Galetta
Contact Person Email
galetta@oncologico.bari.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Oncologia Toracica
Contact Person Name
Gianluca Spitaleri
Contact Person Email
gianluca.spitaleri@ieo.it
Site Name
Azienda Ospedaliero Universitaria Delle Marche
Department Name
SOD Clinica Oncologica
Contact Person Name
Rossana Berardi
Site Name
Humanitas Mirasole S.p.A.
Department Name
Oncologia Medica ed Ematologia
Contact Person Name
Giovanna Finocchiaro
Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
Oncology Department – SD Oncopneumologia
Contact Person Name
Antonio Chella
Contact Person Email
a.chella@ao-pisa.toscana.it
Site Name
Fondazione IRCCS Istituto Nazionale Dei Tumori
Department Name
S. C. Oncologia Medica 1
Contact Person Name
Arsela Prelaj
Contact Person Email
arsela20@hotmail.it
Site Name
Istituto Oncologico Veneto
Department Name
Second Medical Oncology Unit
Contact Person Name
Giulia Pasello
Contact Person Email
giulia.pasello@ioveneto.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
Dipartimentale di Oncologia Toracica
Contact Person Name
Angelo Delmonte
Contact Person Email
angelo.delmonte@irst.emr.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Dipartimento di Oncologia ed Ematologia
Contact Person Name
Chiara Bennati
Contact Person Email
chiara.bennati@auslromagna.it
Site Name
I.F.O. Istituti Fisioterapici Ospitalieri
Department Name
UOSD Sperimentazioni cliniche
Contact Person Name
Lorenza Landi
Contact Person Email
landi.lorenza@gmail.com
Site Name
Ospedale S G Moscati
Department Name
Department of Oncology
Contact Person Name
Salvatore Pisconti

Germany

Earliest CTIS Part Ii Submission Date
20-05-2025
Latest Decision Or Authorization Date
12-11-2025
Processing Time Days
176
Number Of Sites
6
Number Of Participants
17

Sites

Site Name
HELIOS Klinikum Emil von Behring GmbH
Department Name
Helios Klinikum Emil von Behring
Contact Person Name
Jens Kollmeier
Site Name
Klinikum der Universitaet Muenchen AöR
Department Name
Medizinische Klinik und Poliklinik V
Contact Person Name
Amanda Tufman
Site Name
LungenClinic Grosshansdorf GmbH
Department Name
LungenClinic Grosshansdorf
Contact Person Name
Martin Reck
Contact Person Email
m.reck@lungenclinic.de
Site Name
MVZ-Onkologie Velbert GbR
Department Name
MVZ-Onkologie Velbert
Contact Person Name
Arnd Nusch
Contact Person Email
nusch@aol.com
Site Name
Lungenfachklinik Immenhausen
Department Name
Lungenfachklinik Immenhausen
Contact Person Name
Achim Rittmeyer
Site Name
Klinikum Esslingen GmbH
Department Name
Klinik für Kardiologie, Angiologie und Pneumologie
Contact Person Name
Martin Faehling

Austria

Earliest CTIS Part Ii Submission Date
21-05-2025
Latest Decision Or Authorization Date
17-11-2025
Processing Time Days
180
Number Of Sites
2
Number Of Participants
11

Sites

Site Name
Stadt Wien Wiener Gesundheitsverbund
Department Name
Klinik Floridsdorf Abteilung für Innere Medizin und Pneumologie
Contact Person Name
Maximilian Hochmair
Site Name
Medizinische Universitaet Innsbruck
Department Name
Universitätsklinik für Innere Medizin V Innsbruck
Contact Person Name
Arno Amann
Contact Person Email
arno.amann@tirol-kliniken.at

Spain

Earliest CTIS Part Ii Submission Date
08-05-2025
Latest Decision Or Authorization Date
17-11-2025
Processing Time Days
193
Number Of Sites
11
Number Of Participants
32

Sites

Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Oncología Médica
Contact Person Name
Antonio Calles Blanco
Contact Person Email
antonio.calles@live.com
Site Name
Micancer Center S.L.P.
Department Name
Oncología Médica
Contact Person Name
Santiago Viteri Ramires
Contact Person Email
sviteri@uomi.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncología Médica
Contact Person Name
Pilar Garrido Lopez
Contact Person Email
pgarrido@salud.madrid.org
Site Name
Institut Catala D'oncologia (Badalona)
Department Name
Oncología Médica
Contact Person Name
Maria Teresa Moran Bueno
Contact Person Email
mmoran@iconcologia.net
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncología Médica
Contact Person Name
Luis Gonzaga Paz-Ares Rodriguez
Contact Person Email
lpazaresr@seom.org
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncología Médica
Contact Person Name
Miriam Alonso Garcia
Contact Person Email
miriamag3@hotmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Oncología Médica
Contact Person Name
Teresa García Manrique
Contact Person Email
tgarciamanrique.onco@gmail.com
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncología Médica
Contact Person Name
María Rosario Garcia Campelo
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncología Médica
Contact Person Name
Manuel Cobo Dols
Contact Person Email
manuelcobodols@yahoo.es
Site Name
Institut Catala D'oncologia (L'hospitalet De Llobregat)
Department Name
Oncología Médica
Contact Person Name
Ernest Nada Alforja
Site Name
Institut Catala D'oncologia (Girona)
Department Name
Oncología Médica
Contact Person Name
Elia Sais Girona

Poland

Earliest CTIS Part Ii Submission Date
09-05-2025
Latest Decision Or Authorization Date
15-11-2025
Processing Time Days
190
Number Of Sites
4
Number Of Participants
20

Sites

Site Name
One Day Med Sp. z o.o.
Contact Person Name
Piotr Serwatowski
Contact Person Email
piotrserwatowski@wp.pl
Site Name
Zanamed Medical Clinic Sp. z o.o.
Contact Person Name
Ludmiła Grzybowska-Szatkowska
Contact Person Email
ludmila.szatkowska@zanamed.pl
Site Name
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Department Name
Oddział Dzienny Chemioterapii i Hematologii Onkologicznej
Contact Person Name
Dariusz Sawka
Site Name
Uniwersyteckie Centrum Kliniczne
Department Name
Klinika Onkologii i Radioterapii
Contact Person Name
Anna Wrona
Contact Person Email
anna.wrona@gumed.edu.pl

Netherlands

Earliest CTIS Part Ii Submission Date
23-05-2025
Latest Decision Or Authorization Date
11-11-2025
Processing Time Days
172
Number Of Sites
3
Number Of Participants
22

Sites

Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Lung Cancer Center and Thoracic Oncology
Contact Person Name
Adrianus Johannes (Joop) De Langen
Contact Person Email
j.d.langen@nki.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Cancer Center / Pulmonary Diseases
Contact Person Name
Anne van Lindert
Site Name
Radboud universitair medisch centrum Stichting
Department Name
Thoracic Oncology
Contact Person Name
Miep van der Drift
Contact Person Email
miep.vanderdrift@radboudumc.nl

Czechia

Earliest CTIS Part Ii Submission Date
08-05-2025
Latest Decision Or Authorization Date
11-11-2025
Processing Time Days
187
Number Of Sites
2
Number Of Participants
7

Sites

Site Name
Multiscan s.r.o.
Department Name
Komplexni Onkologicke Centrum Pardubickeho kraje
Contact Person Name
Karel Odrážka
Contact Person Email
odrazka@multiscan.cz
Site Name
Nemocnice AGEL Novy Jicin a.s.
Department Name
Komplexni onkologicke centrum Oddeleni onkologie a radioterapie
Contact Person Name
Vojtech Tlusty
Contact Person Email
vojtech.tlusty@nnjagel.cz

Belgium

Earliest CTIS Part Ii Submission Date
06-05-2025
Latest Decision Or Authorization Date
12-11-2025
Processing Time Days
190
Number Of Sites
3
Number Of Participants
11

Sites

Site Name
Cliniques Universitaires Saint-Luc
Department Name
Pneumology
Contact Person Name
Frank Aboubakar
Site Name
Universitair Ziekenhuis Antwerpen
Department Name
Pneumology
Contact Person Name
Jo Raskin
Contact Person Email
jo.raskin@uza.be
Site Name
UZ Leuven
Department Name
Pneumology
Contact Person Name
Christophe Dooms
Contact Person Email
christophe.dooms@uzleuven.be

Portugal

Earliest CTIS Part Ii Submission Date
26-02-2025
Latest Decision Or Authorization Date
11-11-2025
Processing Time Days
258
Number Of Sites
4
Number Of Participants
15

Sites

Site Name
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Department Name
Medical Oncology
Contact Person Name
Marta Soares
Site Name
Champalimaud Clinical Centre
Department Name
Pneumology Unit
Contact Person Name
Marcos Pantarotto
Site Name
Galo Saude Parcerias Cascais S.A.
Department Name
Oncology
Contact Person Name
Diogo Alpuim Costa
Site Name
Hospital CUF Porto S.A.
Department Name
Oncology
Contact Person Name
Venceslau Hespanhol
Contact Person Email
hespanholv@gmail.com

France

Earliest CTIS Part Ii Submission Date
23-05-2025
Latest Decision Or Authorization Date
06-01-2026
Processing Time Days
228
Number Of Sites
11
Number Of Participants
56

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Service de pneumologie
Contact Person Name
Jacques CADRANEL
Contact Person Email
Jacques.cadranel@aphp.fr
Site Name
Institut Bergonie
Department Name
Medical Oncology, 229 cours de l’Argonne
Contact Person Name
Sophie COUSIN
Contact Person Email
s.cousin@bordeaux.unicancer.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Multidisciplinary oncology and therapeutic innovations
Contact Person Name
Pascale TOMASINI
Contact Person Email
pascale.tomasini@ap-hm.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Oncology Medical Department
Contact Person Name
Elvire PONS-TOSTIVINT
Contact Person Email
Elvire.pons@chu-nantes.fr
Site Name
Institut Regional Du Cancer De Montpellier
Department Name
Medical oncology
Contact Person Name
Xavier QUANTIN
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Hôpital du Haut Lévêque, Centre François Magendie, Service des Maladies Respiratoires
Contact Person Name
Rémi VEILLON
Contact Person Email
Remi.veillon@chu-bordeaux.fr
Site Name
Centre Francois Baclesse
Department Name
Department of Pneumology
Contact Person Name
Hubert CURCIO
Contact Person Email
h.curcio@baclesse.unicancer.fr
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Pneumology
Contact Person Name
Youssef OULKHOUIR
Site Name
Centre Leon Berard
Department Name
Department of Medical Oncology
Contact Person Name
Aurélie SWALDUZ
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Pneumology
Contact Person Name
Julien MAZIERES
Contact Person Email
mazieres.j@chu-toulouse.fr
Site Name
Institut Gustave Roussy
Department Name
Medical oncology
Contact Person Name
Benjamin BESSE

Hungary

Earliest CTIS Part Ii Submission Date
15-05-2025
Latest Decision Or Authorization Date
13-02-2026
Processing Time Days
274
Number Of Sites
4
Number Of Participants
11

Sites

Site Name
Bacs-Kiskun Varmegyei Oktatokorhaz
Department Name
Onkoradiológiai Központ
Contact Person Name
Zsuzsanna Kelemen
Site Name
Matrai Gyogyintezet
Department Name
Oncológiai
Contact Person Name
Albert István
Contact Person Email
albert.magy@gmail.com
Site Name
University Of Debrecen
Department Name
Tüdőgyógyászati Klinika
Contact Person Name
Ildikó Horváth
Contact Person Email
horvath.ildiko@med.unideb.hu
Site Name
Bekes Varmegyei Koezponti Korhaz
Department Name
Aktív Tüdőgyógyászati Osztály
Contact Person Name
Ibolya Laczó
Contact Person Email
laczoibolya@gmail.com

Denmark

Earliest CTIS Part Ii Submission Date
12-05-2025
Latest Decision Or Authorization Date
25-02-2026
Processing Time Days
289
Number Of Sites
3
Number Of Participants
6

Sites

Site Name
Region Midtjylland
Department Name
Department of Oncology
Contact Person Name
Peter Meldgaard
Contact Person Email
petemeld@rm.dk
Site Name
Odense University Hospital
Department Name
Department of Oncology
Contact Person Name
Lotte Holm Land
Contact Person Email
ouh.ode.r.ctis@rsyd.dk
Site Name
Region Hovedstaden
Department Name
Department of Oncology
Contact Person Name
Rikke Andersen
Contact Person Email
Rikke.andersen.02@regionh.dk

Greece

Earliest CTIS Part Ii Submission Date
26-02-2025
Latest Decision Or Authorization Date
22-04-2026
Processing Time Days
420
Number Of Sites
5
Number Of Participants
18

Sites

Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
Oncology Unit, 3'd Department of Ιnternal Medicine and Laboratory
Contact Person Name
Konstantinos Syrigos
Contact Person Email
ksyrigos.trials@gmail.com
Site Name
General University Hospital Of Larissa
Department Name
Dpt of Medical Oncology
Contact Person Name
Athanasios Kotsakis
Contact Person Email
thankotsakis@hotmail.com
Site Name
Athens Medical Center S.A.
Department Name
Oncology Department
Contact Person Name
Vasileios Ramfidis
Contact Person Email
ramfidis@gmail.com
Site Name
Henry Dunant Hospital Center
Department Name
4th’ Oncology Dept & Clinical Trials unit
Contact Person Name
Ioannis Mountzios
Contact Person Email
gmountzios@gmail.com
Site Name
Genesis Idiotiki Geniki Maieftiki Gynaikologiki Kliniki S.A.
Department Name
Medical Oncology
Contact Person Name
Ioannis Boukovinas
Contact Person Email
ibouk@bioncology.gr

Sponsor

Primary sponsor

Full Name
Nuvalent Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
PPD International Holdings LLC
Responsibilities
Kit supplies, Processing of Biomarker samples, Project manager, Sample management
Name
PPD Development LP
Name
PPD Global Ltd.
Name
PPD Global Central Labs (S) Pte Ltd
Responsibilities
Kit supplies, Processing of Biomarker samples, Project manager, Sample management
Name
Pra International
Responsibilities
Central Imaging for tumor assessments
Name
Fortrea Inc.
Responsibilities
Safety case processing
Name
Almac Clinical Services Limited
Responsibilities
Labelling and QP release for NVL-655 (neladalkib) and ALECENSA (alectinib)
Name
WCG Clinical Inc.
Responsibilities
ePROs
Name
Scout Clinical
Responsibilities
Travel Management and Expense Reimbursement
Name
Pharmaceutical Product Development LLC
Responsibilities
Kit supplies, Processing of Biomarker samples, Project manager, Sample management

Third parties

  • {"country":"Belgium","full_name":"PPD International Holdings LLC","duties_or_roles":"Kit supplies, Processing of Biomarker samples, Project manager, Sample management","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pra International","duties_or_roles":"Central Imaging for tumor assessments","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Safety case processing","organisation_type":"Pharmaceutical company"}
  • {"country":"Singapore","full_name":"PPD Global Central Labs (S) Pte Ltd","duties_or_roles":"Kit supplies, Processing of Biomarker samples, Project manager, Sample management","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Travel Management and Expense Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"Labelling and QP release for NVL-655 (neladalkib) and ALECENSA (alectinib)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"WCG Clinical Inc.","duties_or_roles":"ePROs","organisation_type":"Pharmaceutical company"}
  • {"country":"France","full_name":"Voisin Consulting Life Sciences","duties_or_roles":"EU Data Protection Representative","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Kit supplies, Processing of Biomarker samples, Project manager, Sample management","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
NVL-655
Active Substance
NVL-655 (neladalkib)
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Not authorised / Investigational (prodAuthStatus: 1)
Maximum Dose
Max daily dose amount 150 mg
Investigational Product Name
Alecensa 150 mg hard capsules
Active Substance
ALECTINIB HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised (prodAuthStatus: 2)
Starting Dose
150 mg (capsule strength listed)
Maximum Dose
Max daily dose amount 1200 mg

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