Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
Recruiting · NCT06765109 · Interventional (participants receive a specific treatment) · Lead sponsor: Nuvalent Inc.
View the official record on ClinicalTrials.gov →Interventions studied
AlectinibNeladalkib (NVL-655)
What this trial is about
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).
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed across 15 US states.
- Palo Verde Hematology Oncology - Glendale, Arizona, United States
- Hoag Hospital Newport Beach - Newport Beach, California, United States
- University of California, Irvine Health - Orange, California, United States
- Rocky Mountain Cancer Centers - Boulder, Colorado, United States
- Sylvester Comprehensive Cancer Center Miami - Miami, Florida, United States
- AdventHealth Cancer Institute - Orlando, Florida, United States
- H Lee Moffitt Cancer Center and Research Institute - Tampa, Florida, United States
- Winship Cancer Institute of Emory University - Atlanta, Georgia, United States
- Dana-Farber Cancer Institute - Boston, Massachusetts, United States
- Barbara Ann Karmanos Cancer Institute - Detroit, Michigan, United States
- Washington University Center for Advanced Medicine - St Louis, Missouri, United States
- NYU Langone's Perlmutter Cancer Center - New York, New York, United States
- Memorial Sloan Kettering Cancer Center - New York, New York, United States
- Optum Medical Care, PC - Westbury, New York, United States
- Carolinas Medical Center - Charlotte, North Carolina, United States
- Duke Cancer Center - Durham, North Carolina, United States
- University of Cincinnati Cancer Center - Cincinnati, Ohio, United States
- The Ohio State University - Columbus, Ohio, United States
- Alliance Cancer Specialists - Sellersville, Pennsylvania, United States
- SCRI Oncology Partners - Nashville, Tennessee, United States
- Virginia Cancer Specialists - Fairfax, Virginia, United States
- University of Washington - Fred Hutchinson Cancer Center - Seattle, Washington, United States
- Compass Oncology - Vancouver, Washington, United States
- Complejo Hospitalario Universitario a Coruña - A Coruña, Spain
- Aarhus Universitetshospital - Aarhus, Denmark
- Hospital de Cascais - Alcabideche, Portugal
- Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis - Amsterdam, Netherlands
- Azienda Ospedaliero Universitaria delle Marche - Ancona, Italy
- Centre Hospitalier Universitaire d' Angers - Angers, France
- Henry Dunant Hospital Center - Athens, Greece
- Sotiria Thoracic Diseases Hospital of Athens - Athens, Greece
- ICO Badalona H.U. Germans Trias i Pujol - Badalona, Spain
- Phramongkutklao Hospital - Bangkok, Thailand
- Ramathibodi Hospital, Mahidol University - Bangkok, Thailand
- Siriraj Hospital Mahidol University - Bangkok, Thailand
- UOMi Cancer Center - Barcelona, Spain
- IRCCS Istituto Tumori Giovanni Paolo II - Bari, Italy
- Fundação Pio XII - Barretos, Brazil
- Santa Casa de Misericordia de Belo Horizonte - Belo Horizonte, Brazil
- Helios Klinikum Emil von Behring GmbH - Berlin, Germany
- Institut Bergonie - Bordeaux, France
- Cliniques Universitaires Saint-Luc - Brussels, Belgium
- Szpital Specjalistyczny w Brzozowie - Brzozów, Poland
- Centre Francois Baclesse - Caen, France
- Cambridge University Hospitals NHS Trust, Addenbrooke's Hospital - Cambridge, United Kingdom
- Chungbuk National University Hospital - Cheongju-si, South Korea
- Maharaj Nakorn Chiang Mai Hospital - Chiang Mai, Thailand
- Aichi Cancer Center - Chikusa, Japan
- Sanatorio Allende - Córdoba, Argentina
- Centro Médico Privado CEMIC - Córdoba, Argentina
- Debreceni Egyetem Klinikai Kozpont Nagyerdei Campus - Debrecen, Hungary
- Rajavithi Hospital - Din Daeng, Thailand
- Antwerp University Hospital - Edegem, Belgium
- Klinikum Esslingen GmbH - Esslingen am Neckar, Germany
- Uniwersyteckie Centrum Kliniczne - Gdansk, Poland
- Hospital Universitari de Girona Dr Josep Trueta - Girona, Spain
- Center for Lung Cancer, National Cancer Center - Goyang-si, South Korea
- LungenClinic Grosshansdorf GmBH - Großhansdorf, Germany
- Royal Surrey County Hospital - Guildford, United Kingdom
- Matrai Gyogyintezet - Gyöngyös, Hungary
Showing 60 of 158 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →