癌研連線CancerLink
Recruiting NCT06765109

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

Non-Small Cell Lung CancerLymphomaPhase 3Stage IIIStage IVALK

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 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

  • 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

Eligibility criteria are kept as the original English records from ClinicalTrials.gov; actual eligibility is determined by the research team's formal assessment and the informed consent form. Source: ClinicalTrials.gov, updated automatically every two weeks. Last synced: 2026年10月8日.