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Protocol NumberNVL-655-04
NCT Number(ClinicalTrials.gov Identfier)NCT06765109
Active

2025-02-01 - 2030-12-31

Recruiting4

ICD-10C34.90

Malignant neoplasm of unspecified part of unspecified bronchus or lung

ICD-10C34.91

Malignant neoplasm of unspecified part of right bronchus or lung

ICD-10C34.92

Malignant neoplasm of unspecified part of left bronchus or lung

ICD-10C7A.090

Malignant carcinoid tumor of the bronchus and lung

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9162.9

Malignant neoplasm of bronchus and lung, unspecified

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)

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/04/10

Investigators and Locations

Principal Investigator Gee-chen Chang Division of General Internal Medicine
Chung Shan Medical University Hospital

Co-Principal Investigator

  • 曲承鑲 Division of General Internal Medicine
  • 鄭哲融 Division of General Internal Medicine
  • 吳珈潤 Division of General Internal Medicine
  • 陳焜結 Division of General Internal Medicine

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jen-Yu Hung Division of Thoracic Medicine
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chien-Chung Lin
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Non-small Cell Lung Cancer 、Anaplastic Lymphoma Kinase-positive

Objectives

Primary: 1. Evaluate the efficacy of NVL-655 compared to alectinib in treatment-naïve ALK-positive advanced NSCLC patients. Secondary: 1. Evaluate other efficacy endpoints of NVL-655 compared to alectinib in treatment-naïve ALK-positive advanced NSCLC patients. 2. Evaluate the safety and tolerability of NVL-655 compared to alectinib. 3. Evaluate and compare patient-reported health-related quality of life (QoL), lung cancer symptoms, patient function, and treatment side effects. Exploratory: 1. Explore candidate biomarkers/molecular mechanisms of response and resistance to NVL-655 and alectinib. 2. Evaluate progression-free survival (PFS) with subsequent therapy.

Test Drug

Tablets; Hard capsules

Active Ingredient

NVL-655

Dosage Form

110
110

Dosage

50mg與150mg
50 or 150 mg

Endpoints

Progression-free survival (PFS) is defined as the time elapsed from randomization to radiographic progression or patient death as assessed by a blinded independent central review (BICR) according to the Responsive Criteria for Solid Tumor Response (RECIST 1.1).

Inclution Criteria

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

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

The Estimated Number of Participants

  • Taiwan

    10 participants

  • Global

    450 participants

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