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Treatment for advanced ALK-positive non-small cell lung cancer

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)

PHASE3 · Nuvalent Inc. · NCT06765109

This study is testing whether a new drug called neladalkib can help people with advanced ALK-positive non-small cell lung cancer live longer without their disease getting worse compared to the standard treatment, alectinib.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment450 (estimated)
Ages18 Years and up
SexAll
SponsorNuvalent Inc. (industry)
Drugs / interventionsalectinib, chemotherapy
Locations149 sites (Glendale, Arizona and 148 other locations)
Trial IDNCT06765109 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial is a multicenter, randomized, controlled, open-label study aimed at comparing the efficacy of neladalkib (NVL-655) against alectinib in prolonging progression-free survival in treatment-naïve patients with advanced ALK-positive non-small cell lung cancer (NSCLC). Approximately 450 participants will be randomly assigned in a 1:1 ratio to receive either neladalkib or alectinib. The study focuses on patients with confirmed ALK rearrangement and measurable disease, ensuring a robust evaluation of the new treatment's effectiveness.

Who should consider this trial

Good fit: Ideal candidates are treatment-naïve patients with advanced ALK-positive non-small cell lung cancer who have measurable disease.

Not a fit: Patients with known oncogenic driver alterations other than ALK or those who have previously received ALK tyrosine kinase inhibitors will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve progression-free survival for patients with advanced ALK-positive NSCLC.

How similar studies have performed: Other studies have shown promising results with similar approaches targeting ALK-positive NSCLC, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Glendale, Arizona and 148 other locations

+99 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Non-small Cell Lung Cancer, Anaplastic Lymphoma Kinase-positive, NSCLC, Lung cancer, Lung neoplasms, Lung diseases, ALK positive NSCLC, TKI naive

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.