Actively Recruiting
A Phase 3 Study Comparing Neladalkib NVL-655 and Alectinib as First-Line Treatment for ALK-Positive Advanced Non-Small Cell Lung Cancer
Led by Nuvalent Inc. · Updated on 2026-06-02
450
Participants Needed
155
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating neladalkib NVL-655 compared to alectinib for patients with advanced Anaplastic Lymphoma Kinase ALK positive Non-Small Cell Lung Cancer NSCLC who have not yet received treatment. This Phase 3, multicenter, randomized, controlled, open-label study aims to see if neladalkib can better prolong progression-free survival PFS than alectinib in this patient group. Participants will be randomly assigned in equal numbers to receive either neladalkib or alectinib. Neladalkib is taken as a 150 mg oral tablet once daily, while alectinib is taken as a 600 mg oral capsule twice daily. The study includes up to 5 years of follow-up to assess outcomes and compare the two treatments. During the study, participants will undergo regular evaluations including imaging to measure disease progression, laboratory tests, and assessments of symptoms and quality of life. Researchers will monitor progression-free survival as the primary outcome, along with overall survival, response rates, intracranial progression, and treatment side effects. Patient-reported measures on lung cancer symptoms, functioning, and quality of life will also be collected throughout the follow-up period.
CONDITIONS
Brief Title
Neladalkib (NVL-655) for TKI-naive Patients With Advanced ALK-Positive NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed locally advanced or metastatic Non-small Cell Lung Cancer not suitable for multimodality treatment
- Documented ALK rearrangement confirmed by tissue or blood testing
- No prior systemic anticancer treatment for NSCLC (prior chemotherapy allowed if at least 12 months before randomization; prior ALK TKI including alectinib not allowed)
- Presence of measurable disease with one or more target lesions per RECIST 1.1
- Availability of pretreatment tumor tissue sample
You will not qualify if you...
- Presence of known oncogenic driver alteration other than ALK
- Known allergy or hypersensitivity to components of neladalkib or alectinib
- Recent or ongoing radiotherapy within protocol-specified time frames before randomization
- Major surgery within 4 weeks before randomization
- Uncontrolled infection requiring systemic therapy
- Active tuberculosis or active Hepatitis B or C infection
- QTcF interval greater than 470 msec on repeated measurements
- Significant cardiovascular disease
- Brain metastases with progressive neurological symptoms or requiring increased corticosteroids
- Active malignancy requiring treatment within 2 years prior to randomization
Research Team
N
Nuvalent Clinical Trials
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