Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNuvalent Inc.
About this trial
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).
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Neladalkib (NVL-655)
- Alectinib
Treatment groups
450 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov