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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)
Cancer Categories
Lung
Karmanos Trial ID
2025-054
NCT ID
NCT06765109
Age Group
Adult
Scope
National
Phase
Phase III
Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug
Phase III
Principal Investigator
Dipesh
Uprety, M.D.
Oncology - Medical
View Profile
Objective:
Primary Objective:
To evaluate the efficacy of NVL-655 compared to alectinib in patients with treatment-naïve ALK-positive advanced NSCLC
Secondary Objectives:
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
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Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
Eligibility
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:
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
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
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Phone:
1-800-527-6266
Karmanos Cancer Institute at Weisberg Cancer Center - Farmington Hills
31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone:
1-800-527-6266
Applicable Disease Site
Applicable Disease Site
Lung
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Therapies
Biological Therapy, Chemotherapy
Drugs
Alectinib; NVL-655
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