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A Phase III 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)

UCI Specialty Area: Cancer
Principal Investigator: Misako Nagasaka
A Study On:
Lung

Study Description

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

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 (archived or a fresh biopsy)

Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2

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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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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