A Study of NVL-520 in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)

Launched by NUVALENT INC. · Nov 3, 2021

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ClinConnect Summary

The ARROS-1 clinical trial is studying a new treatment called NVL-520 for patients with advanced solid tumors, specifically those with a certain genetic change known as ROS1 rearrangement. This trial has two phases: the first phase focuses on finding the safest dose of NVL-520 and how well it is tolerated, while the second phase will look at how effective it is in shrinking tumors in patients with advanced non-small cell lung cancer (NSCLC) and other solid tumors that also have this genetic change.

To be eligible for the study, participants need to be at least 18 years old (or 12 years old and weighing over 40 kg for a specific group) and must have a confirmed diagnosis of an advanced solid tumor with ROS1 rearrangement. They should also have had prior cancer treatment, except for one specific group. During the trial, participants will receive the treatment and will be closely monitored for its effects, including how long the response lasts and how it impacts their overall survival. It’s important to know that individuals with certain other cancer alterations or those currently undergoing other cancer treatments may not be eligible for this study.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≥18 years (Cohort 2e only: Age ≥12 years and weighing\>40 kg).
• 2. Disease Criteria:
• • 1. Phase 1: Histologically or cytologically confirmed locally advanced or metastatic solid tumor with documented ROS1 rearrangement.
• • 2. Phase 2: Cohorts 2a, 2b, 2c and 2d: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with ROS1 rearrangement.
• • 3. Phase 2: Cohort 2e: Histologically or cytologically confirmed locally advanced or metastatic solid tumor (other than NSCLC) with ROS1 rearrangement.
• • 3. Prior anticancer treatment (except cohort 2a).
• • 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 baseline organ function and bone marrow reserve.
• Exclusion Criteria:
• • 1. Patient's cancer has a known oncogenic driver alteration other than ROS1.
• • 2. Known allergy/hypersensitivity to excipients of NVL-520.
• • 3. Major surgery within 4 weeks of first dose of study drug.
• • 4. Ongoing anticancer therapy.
• • 5. Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study.