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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Neladalkib (NVL-655)
DrugOral tablet of Neladalkib (NVL-655)
Alectinib
DrugOral capsule of alectinib
Treatment groups
450 Participants
are divided into 2 treatment groupsGroup A: Neladalkib (NVL-655)Experimental treatment 1 intervention
Group B: AlectinibActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Progression-free survival (PFS) per blinded independent central review (BICR)
Time from randomization to BICR-assessed radiographic disease progression or death
Time frame
Up to 5 years after first patient dosedSecondary outcomes
1
Overall survival (OS)
Time from randomization to death
Time frame
Up to 5 years after first patient dosed2
Progression-free survival (PFS) per investigator assessment
Time from randomization to investigator-assessed radiographic disease progression or death
Time frame
Up to 5 years after first patient dosed3
Time to intracranial progression per BICR
Time from randomization to the first BICR-assessed occurrence of disease progression in the central nervous system (CNS)
Time frame
Up to 5 years after first patient dosed4
Intracranial objective response rate (IC-ORR)
Proportion of patients with a confirmed intracranial response (intracranial complete response \[IC-CR\] or intracranial partial response \[IC-PR\]) among patients with measurable CNS disease at baseline
Time frame
Up to 5 years after first patient dosedSponsors and contacts
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Source ClinicalTrials.gov