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Back|NCT06765109Recruiting
Official 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)

Phase
Phase 3
Sponsor
Nuvalent Inc.
Enrollment
450
Timeline
Jul 2025 → Dec 2029
About This Study

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 Criteria

Inclusion Criteria

  • 1Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC)
  • 2Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood
  • 3No 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)
  • 4Measurable disease (1 or more target lesions per Response Evaluation Criteria in Solid Tumors \[RECIST\] 1.1)
  • 5Pretreatment tumor tissue

Exclusion Criteria

  • 1Patient's cancer has a known oncogenic driver alteration other than ALK.
  • 2Known allergy/hypersensitivity to excipients of neladalkib or alectinib.
  • 3Ongoing or recent radiotherapy as per protocol-specified timeframes prior to randomization
  • 4Major surgery within 4 weeks prior to randomization
  • 5Uncontrolled clinically relevant infection requiring systemic therapy
  • 6Known active tuberculosis, or active Hepatitis B or C
  • 7QT corrected for heart rate by Fridericia's formula (QTcF) \> 470 msec on repeated assessments
  • 8Clinically significant cardiovascular disease
  • 9Brain metastases associated with progressive neurological symptoms or requiring increasing doses of corticosteroids to control CNS disease
  • 10Active malignancy requiring therapy within 2 years prior to randomization

Locations

88 sites participating in this study

Winship Cancer Institute of Emory University

Atlanta, Georgia 30322

Recruiting

Ticiana Leal, M.D.

Palo Verde Hematology Oncology

Glendale, Arizona 85304

Recruiting

Amol Nanak Singh Rakkar, M.D.

University of California, Irvine Health

Orange, California 92868

Recruiting

Misako Nagasaka, M.D., Ph.D.

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →