Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC

Purpose

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).

Conditions

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Histologically or cytologically confirmed locally advanced (not amenable for multimodality treatment) or metastatic Non-small Cell Lung Cancer (NSCLC) 2. Documented Anaplastic Lymphoma Kinase (ALK) rearrangement via testing of tissue or blood 3. 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) 4. Measurable disease (1 or more target lesions per Response Evaluation Criteria in Solid Tumors [RECIST] 1.1) 5. Pretreatment tumor tissue

Exclusion Criteria

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Neladalkib (NVL-655) 		150mg taken orally once daily (QD)
  • Drug: Neladalkib (NVL-655)
    Oral tablet of Neladalkib (NVL-655)
Active Comparator
Alectinib 		600mg taken orally twice daily (BID)
  • Drug: Alectinib
    Oral capsule of alectinib
    Other names:
    • Alecensa

Recruiting Locations

Palo Verde Hematology Oncology
Glendale, Arizona 85304

Hoag Hospital Newport Beach
Newport Beach, California 92663

University of California, Irvine Health
Orange, California 92868

Rocky Mountain Cancer Centers
Boulder, Colorado 80218

Sylvester Comprehensive Cancer Center Miami
Miami, Florida 33136

AdventHealth Cancer Institute
Orlando, Florida 32804

H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida 33612

Winship Cancer Institute of Emory University
Atlanta, Georgia 30322

Dana-Farber Cancer Institute
Boston, Massachusetts 02215

Washington University Center for Advanced Medicine
St Louis, Missouri 63110

NYU Langone's Perlmutter Cancer Center
New York, New York 10016

Memorial Sloan Kettering Cancer Center
New York, New York 10065

Optum Medical Care, PC
Westbury, New York 11590

Carolinas Medical Center
Charlotte, North Carolina 28203

Duke Cancer Center
Durham, North Carolina 27710

University of Cincinnati Cancer Center
Cincinnati, Ohio 45267

The Ohio State University
Columbus, Ohio 43210

Alliance Cancer Specialists
Sellersville, Pennsylvania 18960

SCRI Oncology Partners
Nashville, Tennessee 37203

Virginia Cancer Specialists
Fairfax, Virginia 22031

University of Washington - Fred Hutchinson Cancer Center
Seattle, Washington 98109

Compass Oncology
Vancouver, Washington 98684

More Details

Status
Recruiting
Sponsor
Nuvalent Inc.

Study Contact

Nuvalent Clinical Trials
857-357-7000
clinicaltrials@nuvalent.com

Detailed Description

Patients will be randomized in a 1:1 ratio (approximately 225 in each arm) to receive either neladalkib (NVL-655) or alectinib.