Health Trials

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 groups

Locations

156
Argentina
Sanatorio Parque S.A.S20000DSV, RosarioSanta Fe Province, Argentina
Centro Médico Privado CEMICX5008, Córdoba Argentina
Sanatorio Allende5000, Córdoba Argentina
Australia
Westmead Hospital2145, WestmeadNew South Wales, Australia

Sponsors and collaborators

Nuvalent Inc.

Lead sponsor

Source ClinicalTrials.gov