Clinical Trial 23482

• Overview

  Study Title:

  A Phase 3 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 Compared to Alectinib in First-Line Treatment of Patients With ALK-Positive Advanced Non-Small Cell Lung Cancer (ALKAZAR)

  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).

  Objective:

  Primary * To evaluate the efficacy of NVL-655 compared to alectinib in patients with treatment-naïve ALK-positive advanced NSCLC Secondary * To assess additional measures of efficacy of NVL-655 compared to alectinib in patients with treatment-naïve ALK-positive advanced NSCLC To evaluate the safety and tolerability of NVL-655 compared to alectinib * To evaluate and compare patient-reported measures of health-related quality of life (QoL), lung cancer symptoms, patient functioning, and side effects of treatment

• Treatments

  Therapies:

  Tyrosine Kinase Inhibitor

  Medications:

  Alectinib (); NVL-655 ()

• Inclusion Criteria

  Key Inclusion 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 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)
  • Pretreatment tumor tissue

• Exclusion Criteria

  Key Exclusion Criteria:
  • 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
  • Uncontrolled clinically relevant infection requiring systemic therapy
  • Known active tuberculosis, or active Hepatitis B or C
  • QT corrected for heart rate by Fridericia's formula (QTcF) > 470 msec on repeated assessments
  • Clinically significant cardiovascular disease
  • Brain metastases associated with progressive neurological symptoms or requiring increasing doses of corticosteroids to control CNS disease
  • Active malignancy requiring therapy within 2 years prior to randomization

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