NCT06765109Recruiting
Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
Summary
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).
Inclusion criteria
1. Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC) 2. Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood 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) 4. Measurable disease (1 or more target lesions per Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1) 5. Pretreatment tumor tissue
Exclusion criteria
1. Patient's cancer has a known oncogenic driver alteration other than ALK. 2. Known allergy/hypersensitivity to excipients of neladalkib or alectinib. 3. Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization 4. Major surgery within 4 weeks prior to randomization 5. Uncontrolled clinically relevant infection requiring systemic therapy 6. Known active tuberculosis, or active Hepatitis B or C 7. QT corrected for heart rate by Fridericia's formula (QTcF) \> 470 msec on repeated assessments 8. Clinically significant cardiovascular disease 9. Brain metastases associated with progressive neurological symptoms or requiring increasing doses of corticosteroids to control CNS disease 10. Active malignancy requiring therapy within 2 years prior to randomization
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, Austria, United States, Argentina, Australia, Belgium, Brazil, Canada, Chile, Czechia, Denmark, Greece, Hong Kong, Hungary, Japan, Malaysia, Mexico, Netherlands, Poland, Portugal, Singapore, South Korea, Spain, Taiwan, Thailand, United Kingdom
- Sponsor
- Nuvalent Inc.(Industry)
- Protocol no.
- NVL-655-04
- Conditions
- Non-small Cell Lung Cancer, Anaplastic Lymphoma Kinase-positive
- Interventions
- Drug
Treatments studied
- Neladalkib (NVL-655)
- Alectinib
Locations · 158
- Lucerne, SwitzerlandLuzerner KantonsspitalRecruiting at this site
- Angers, FranceCentre Hospitalier Universitaire d' AngersRecruiting at this site
- Bordeaux, FranceInstitut BergonieRecruiting at this site
- Caen, FranceCentre Francois BaclesseRecruiting at this site
- Lyon, FranceCentre Leon BerardRecruiting at this site
- Marseille, FranceHospital NordRecruiting at this site
- Montpellier, FranceInstitut Regional du Cancer de MontpellierRecruiting at this site
- Nantes, FranceCentre Hospitalier Universitaire (CHU) Nantes Hopital Nord LaennecRecruiting at this site
- Paris, FranceAPHP - Hôpital TenonRecruiting at this site
- Pessac, FranceCentre Hospitalier Universitaire (CHU) de BordeauxRecruiting at this site
- Toulouse, FranceCentre Hospitalier Universitaire de Toulouse - Hopital LarreyRecruiting at this site
- Berlin, GermanyHelios Klinikum Emil von Behring GmbHRecruiting at this site
- Esslingen am Neckar, GermanyKlinikum Esslingen GmbHRecruiting at this site
- Großhansdorf, GermanyLungenClinic Grosshansdorf GmBHRecruiting at this site
- Immenhausen, GermanyLungenfachklinik ImmenhausenRecruiting at this site
- Velbert, GermanyMVZ Onkologie VelbertRecruiting at this site
- Ancona, ItalyAzienda Ospedaliero Universitaria delle MarcheRecruiting at this site
- Bari, ItalyIRCCS Istituto Tumori Giovanni Paolo IIRecruiting at this site
- Meldola, ItalyIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST)Recruiting at this site
- Milan, ItalyIstituto Clinico HumanitasRecruiting at this site
- Milan, ItalyFondazione IRCCS Istituto Nazionale dei TumoriRecruiting at this site
- Milan, ItalyIstituto Europeo di OncologiaRecruiting at this site
- Monza, ItalyFondazione IRCCS San Gerardo dei TintoriRecruiting at this site
- Pisa, ItalyAzienda Ospedaliero Universitaria PisanaRecruiting at this site
- Ravenna, ItalyAUSL Della Romagna - Ospedale Santa Maria delle CrociRecruiting at this site
- Roma, ItalyIstituti Fisioterapici Ospitalieri - IRCCS Istituto Nazionale Tumori Regina ElenaRecruiting at this site
- Statte, ItalyASL Taranto Ospedale S. G. MoscatiRecruiting at this site
- Torino, ItalyIstituto di Candiolo IRCCS - Fondazione del Piemonte per l'OncologiaRecruiting at this site
- Vienna, AustriaWiener GesundheitsverbundRecruiting at this site
- Glendale, United StatesPalo Verde Hematology OncologyRecruiting at this site
In total, worldwide, 158 of the 159 sites listed in the registry are recruiting; the other one is not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: September 30, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 128 more locations
Other identifiers
- 2024-517553-26 · EudraCT number
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.