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Evaluating NVL-655 for Advanced ALK-Positive Solid Tumors

A Phase 1/2 Study of the Selective Anaplastic Lymphoma Kinase (ALK) Inhibitor NVL-655 in Patients With Advanced NSCLC and Other Solid Tumors (ALKOVE-1)

Phase1; Phase2 Interventional Nuvalent Inc. · NCT05384626

This study is testing a new drug called NVL-655 to see if it can safely help people with advanced ALK-positive solid tumors, including non-small cell lung cancer.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment840 (estimated)
Ages12 Years and up
SexAll
SponsorNuvalent Inc. Industry-sponsored
Drugs / interventionsceritinib, alectinib, brigatinib, crizotinib, lorlatinib, chemotherapy, immunotherapy
Locations74 sites (Orange, California and 73 other locations)
Trial IDNCT05384626 on ClinicalTrials.gov

What this trial studies

This clinical trial is a Phase 1/2 study designed to assess the safety and tolerability of NVL-655 in patients with advanced solid tumors that have an ALK rearrangement or activating ALK mutation. The trial will involve a dose escalation phase to determine the recommended dose for further testing, followed by an expansion phase to evaluate the drug's effectiveness in various cohorts of patients with ALK-positive non-small cell lung cancer (NSCLC) and other solid tumors. Key outcomes include the objective response rate, duration of response, and overall survival among participants.

Who should consider this trial

Good fit: Ideal candidates include adults with advanced ALK-positive NSCLC or other solid tumors who have previously received specific ALK-targeted therapies.

Not a fit: Patients whose tumors have oncogenic driver alterations other than ALK or those with known allergies to NVL-655 may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced ALK-positive solid tumors who have limited treatment alternatives.

How similar studies have performed: Other studies targeting ALK rearrangements have shown promising results, indicating that this approach is built on a foundation of prior successes in the field.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age ≥18 years, Phase 2 Cohort 2f only: Age ≥12 years and weighing \>40 kg.
2. Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK rearrangement or activating ALK mutation.
3. Phase 2

   1. Phase 2 Cohorts except 2f: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with a documented ALK rearrangement
   2. Phase 2 Cohort 2f: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with a documented ALK rearrangement or activating ALK mutation detected by certified assay.
4. Phase 1: Must have evaluable disease (target or nontarget) according to RECIST 1.1 Phase 2: Must have measurable disease according to RECIST 1.1
5. Adequate organ function and bone marrow reserve

Exclusion criteria:

1. Patient's cancer has a known oncogenic driver alteration other than ALK.
2. Known allergy/hypersensitivity to excipients of NVL-655.
3. Major surgery within 4 weeks of the study entry
4. Ongoing or anticancer therapy
5. Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.

Where this trial is running

Orange, California and 73 other locations

+24 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 → Find more trials like this →
Conditions Locally Advanced Solid TumorMetastatic Solid Tumor
Last reviewed 2026-06-09 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.