Recruiting NCT06765109
Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neladalkib (NVL-655), Alectinib.
- Who it may be relevant to
- Registry conditions: Non-small Cell Lung Cancer, Anaplastic Lymphoma Kinase-positive. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Australia, Austria, Belgium +24
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)
Overview
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).
Detailed description
Patients will be randomized in a 1:1 ratio (approximately 225 in each arm) to receive either neladalkib (NVL-655) or alectinib.
Interventions
- Drug Neladalkib (NVL-655)
Oral tablet of Neladalkib (NVL-655) - Drug Alectinib
Oral capsule of alectinib
Primary outcome measures
- Progression-free survival (PFS) per blinded independent central review (BICR) [Time frame: Up to 5 years after first patient dosed]
Secondary outcome measures (12)
- Overall survival (OS) [Time frame: Up to 5 years after first patient dosed]
- Progression-free survival (PFS) per investigator assessment [Time frame: Up to 5 years after first patient dosed]
- Time to intracranial progression per BICR [Time frame: Up to 5 years after first patient dosed]
- Intracranial objective response rate (IC-ORR) [Time frame: Up to 5 years after first patient dosed]
- Intracranial duration of response (IC-DOR) [Time frame: Up to 5 years after first patient dosed]
- Objective response rate (ORR) [Time frame: Up to 5 years after first patient dosed]
- Duration of response (DOR) [Time frame: Up to 5 years after first patient dosed]
- Intracranial progression per investigator assessment [Time frame: Up to 5 years after first patient dosed]
- Treatment-emergent adverse events (TEAEs) and changes in clinically relevant laboratory parameters [Time frame: Up to 5 years after first patient dosed]
- Patient-reported measures in health-related quality of life (QoL) [Time frame: Up to 5 years after first patient dosed]
- Patient-reported measures in lung cancer symptoms and side effects of treatment [Time frame: Up to 5 years after first patient dosed]
- Patient-reported measures in patient functioning [Time frame: Up to 5 years after first patient dosed]
Eligibility criteria
Inclusion criteria
- Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC)
- Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood
- 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)
- Measurable disease (1 or more target lesions per Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1)
- Pretreatment tumor tissue
Exclusion criteria
- Patient's cancer has a known oncogenic driver alteration other than ALK.
- Known allergy/hypersensitivity to excipients of neladalkib or alectinib.
- Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization
- Major surgery within 4 weeks prior to randomization
- Uncontrolled clinically relevant infection requiring systemic therapy
- Known active tuberculosis, or active Hepatitis B or C
- QT corrected for heart rate by Fridericia's formula (QTcF) > 470 msec on repeated assessments
- Clinically significant cardiovascular disease
- Brain metastases associated with progressive neurological symptoms or requiring increasing doses of corticosteroids to control CNS disease
- Active malignancy requiring therapy within 2 years prior to randomization
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 23 centers
- Palo Verde Hematology Oncology — Glendale
- Hoag Hospital Newport Beach — Newport Beach
- University of California, Irvine Health — Orange
- Rocky Mountain Cancer Centers — Boulder
- Sylvester Comprehensive Cancer Center Miami — Miami
- AdventHealth Cancer Institute — Orlando
- H Lee Moffitt Cancer Center and Research Institute — Tampa
- Winship Cancer Institute of Emory University — Atlanta
- … and 15 more centers
Italy · 12 centers
- Azienda Ospedaliero Universitaria delle Marche — Ancona
- IRCCS Istituto Tumori Giovanni Paolo II — Bari
- Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) — Meldola
- Istituto Clinico Humanitas — Milan
- … and 8 more centers
France · 10 centers
- Centre Hospitalier Universitaire d' Angers — Angers
- Institut Bergonie — Bordeaux
- Centre Francois Baclesse — Caen
- Centre Leon Berard — Lyon
- Hospital Nord — Marseille
- Institut Regional du Cancer de Montpellier — Montpellier
- Centre Hospitalier Universitaire (CHU) Nantes Hopital Nord Laennec — Nantes
- APHP - Hôpital Tenon — Paris
- … and 2 more centers
Japan · 10 centers
Center list to be confirmed — check the primary protocol.
Spain · 10 centers
Center list to be confirmed — check the primary protocol.
Brazil · 8 centers
- Fundação Pio XII — Barretos
- Santa Casa de Misericordia de Belo Horizonte — Belo Horizonte
- Irmandade Da Santa Casa de Misericordia de Porto Alegre — Porto Alegre
- Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul — Porto Alegre
- Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base — São José do Rio Preto
- Instituto do Cancer do Estado de São Paulo ICESP — São Paulo
- A.C.Camargo Cancer Center — São Paulo
- Hospital Amaral Carvalho — São Paulo
United Kingdom · 8 centers
Center list to be confirmed — check the primary protocol.
Malaysia · 6 centers
Center list to be confirmed — check the primary protocol.
South Korea · 6 centers
Center list to be confirmed — check the primary protocol.
Thailand · 6 centers
Center list to be confirmed — check the primary protocol.
Germany · 5 centers
- Helios Klinikum Emil von Behring GmbH — Berlin
- Klinikum Esslingen GmbH — Esslingen am Neckar
- LungenClinic Grosshansdorf GmBH — Großhansdorf
- Lungenfachklinik Immenhausen — Immenhausen
- MVZ Onkologie Velbert — Velbert
Greece · 5 centers
- Henry Dunant Hospital Center — Athens
- Sotiria Thoracic Diseases Hospital of Athens — Athens
- University General Hospital of Larissa — Larissa
- Athens Medical Center — Marousi
- GENESIS General Clinic — Thessaloniki
Mexico · 5 centers
Center list to be confirmed — check the primary protocol.
Chile · 4 centers
- Fundacion Arturo Lopez Perez FALP — Providencia
- Centro de Oncologia de Precision de la Universidad Mayor — Santiago
- Centro de Investigaciones Clinicas UC CICUC — Santiago
- Oncovida - Santiago — Santiago
Poland · 4 centers
Center list to be confirmed — check the primary protocol.
Portugal · 4 centers
Center list to be confirmed — check the primary protocol.
Taiwan · 4 centers
Center list to be confirmed — check the primary protocol.
Argentina · 3 centers
- Sanatorio Parque S.A. — Rosario
- Sanatorio Allende — Córdoba
- Centro Médico Privado CEMIC — Córdoba
Australia · 3 centers
- Westmead Hospital — Westmead
- Austin Health — Heidelberg
- Peter MacCallum Cancer Centre — Melbourne
Belgium · 3 centers
- Cliniques Universitaires Saint-Luc — Brussels
- Antwerp University Hospital — Edegem
- UZ Leuven — Leuven
Denmark · 3 centers
- Aarhus Universitetshospital — Aarhus
- Herlev and Gentofte Hospital — Herlev
- University of Southern Denmark — Odense
Hong Kong · 3 centers
- Queen Mary Hospital Department of Medicine — Hong Kong
- Queen Elizabeth Hospital — Hong Kong
- Prince of Wales Hospital — Shatin
Hungary · 3 centers
- Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus — Debrecen
- Matrai Gyogyintezet — Gyöngyös
- Bacs-Kiskun Varmegyei Oktatokorhaz — Kecskemét
Netherlands · 3 centers
Center list to be confirmed — check the primary protocol.
Singapore · 2 centers
Center list to be confirmed — check the primary protocol.
Austria · 1 center
- Wiener Gesundheitsverbund — Vienna
Canada · 1 center
- Princess Margaret Cancer Centre — Toronto
Czechia · 1 center
- Nemocnice AGEL Nový Jičín a.s. — Nový Jičín
Switzerland · 1 center
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06765109 · NVL-655-04 · 2024-517553-26