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NCT05118789 · ClinicalTrials.gov registry record · Phase 1
A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)
A Phase 1 study of Metastatic Solid Tumor and Locally Advanced Solid Tumor, sponsored by Nuvalent.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 359
- Enrollment target
- 20
- Study locations
NCT05118789: Recruiting Phase 1 study of Metastatic Solid Tumor and Locally Advanced Solid Tumor, sponsored by Nuvalent.
NCT05118789 is a Phase 1 study of Metastatic Solid Tumor and Locally Advanced Solid Tumor that is actively recruiting participants, run by Nuvalent. The registered enrollment target is 359 participants, above the 185-participant average among 52 other Metastatic Solid Tumor trials with a reported enrollment target (94% higher). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05118789, a Phase 1 study of Metastatic Solid Tumor and Locally Advanced Solid Tumor, is actively recruiting participants, sponsored by Nuvalent.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 359 participants
- Enrollment target
- 20
- Study locations
Study Summary
Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of zidesamtinib (NVL-520), determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ROS1-positive (ROS1+) NSCLC and other advanced ROS1-positive solid tumors. Phase 1 will determine the RP2D and, if applicable, the maximum tolerated dose (MTD) of zidesamtinib in patients with advanced ROS1-positive solid tumors. Phase 2 will determine the objective response rate (ORR) as assessed by Blinded Independent Central Review (BICR) of zidesamtinib at the RP2D. Secondary objectives will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS), and clinical benefit rate (CBR) of zidesamtinib in patients with advanced ROS1-positive NSCLC and other solid tumors.
Primary Outcome
Highest dose with dose-limiting toxicity (DLT) rate ≤ 25%
Conditions Studied
Interventions
- DRUG Zidesamtinib (NVL-520)
Study Locations (20)
California
- UCI Medical Center - Orange
- Stanford Medicine - Palo Alto
- UC Davis Comprehensive Cancer Center - Sacramento
Massachusetts
- Mass General Hospital - Boston
- Dana-Farber Cancer Institute - Boston
New York
- NYU Langone Health - New York
- Memorial Sloan Kettering Cancer Center - New York
Colorado
- University of Colorado Cancer Center - Denver
District of Columbia
- Georgetown University Medical Center - Washington D.C.
Florida
- University of Miami - Coral Gables
Illinois
- University of Chicago - Chicago
Michigan
- Henry Ford Cancer Institute - Detroit
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 359 participants |
| Start Date | 2022-01-04 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 1 |
What NCT05118789 shows while recruiting
NCT05118789 is an interventional study that assigns participants to a tested intervention. The registered 359 participants enrollment target is mid-sized for trials with a published cap, above the 185-participant average among 52 other Metastatic Solid Tumor trials with a reported enrollment target (94% higher).
The record links to 2 conditions, with Metastatic Solid Tumor appearing as the primary indexed condition, and to 1 intervention - of which Zidesamtinib (NVL-520) is the first listed.
NCT05118789 names 20 study sites across 16 states, led by California, Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT05118789 about?
NCT05118789 is a clinical study titled "A Study of Zidesamtinib (NVL-520) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ROS1 Rearrangement (ARROS-1)". Phase 1/2, dose escalation and expansion study designed to evaluate the safety and tolerability of zidesamtinib (NVL-520), determine the recommended phase 2 dose (RP2D), and evaluate the antitumor activity in patients with advanced ROS1-positive (ROS1+) NSCLC and other advanced ROS1-positive solid t...
What is the current status of trial NCT05118789?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 359 participants. The study started on 2022-01-04. Estimated completion is 2028-12-31.
What conditions does trial NCT05118789 study?
This clinical trial studies the following conditions: Metastatic Solid Tumor, Locally Advanced Solid Tumor.
What interventions are being tested in trial NCT05118789?
The interventions under investigation include: Zidesamtinib (NVL-520) (DRUG).
Who is sponsoring clinical trial NCT05118789?
This trial is sponsored by Nuvalent, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05118789 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05118789's enrollment target sits among peer trials
359 8th of 52 higher than 45 of 52 other Metastatic Solid Tumor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Solid Tumor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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