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

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).

Conditions

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

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Study Overview

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Study Details

Study overview

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).

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)

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

Condition
Non-small Cell Lung Cancer
Intervention / Treatment

-

Contacts and Locations

New Hyde Park

Clinical Research Alliance Inc., New Hyde Park, New York, United States, 11042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 (archived or a fresh biopsy)
  • 6. Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Nuvalent Inc.,

Viola Zhu, MD, PhD, STUDY_DIRECTOR, Nuvalent Inc.

Study Record Dates

2029-12