Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC

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).

Trial Details

NCT ID
NCT06765109
Phase
PHASE3
Sponsor
Nuvalent Inc.
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • Neladalkib (NVL-655)
  • Alectinib
Locations (sample)
  • Glendale, Arizona, United States|33.53865,-112.18599
  • Newport Beach, California, United States|33.61891,-117.92895
  • Orange, California, United States|33.78779,-117.85311
  • Boulder, Colorado, United States|40.01499,-105.27055
  • Miami, Florida, United States|25.77427,-80.19366

Key Eligibility 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…
  • Measurable disease (1 or more target lesions per Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1)

For full eligibility, visit ClinicalTrials.gov.

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