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ROS1 Inhibitor

NVL-520 for ROS1-Positive Solid Tumors

Phase 1 & 2
Recruiting
Research Sponsored by Nuvalent Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed locally advanced or metastatic solid tumor with documented ROS1 rearrangement for Phase 1
Histologically or cytologically confirmed locally advanced or metastatic NSCLC with ROS1 rearrangement for Cohorts 2a, 2b, 2c, and 2d in Phase 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2-3 years after first patient dosed.
Awards & highlights

Study Summary

This trial is a phase 1/2 study to test the safety and effectiveness of NVL-520 in patients with advanced solid tumors that have a specific gene mutation (ROS1-positive). The study will see how well patients tolerate the drug and if it has any effect on the tumor.

Who is the study for?
This trial is for adults with advanced solid tumors, especially non-small cell lung cancer (NSCLC), that have a specific genetic change called ROS1 rearrangement. Patients should have tried other cancer treatments unless they're in one special group. They need to be healthy enough overall and not currently on another clinical study or recent major surgery.Check my eligibility
What is being tested?
NVL-520 is being tested to see how safe it is and what dose works best against these cancers. The first phase figures out the right dose; the second checks how well it shrinks tumors using independent reviews, also looking at survival times and other health benefits.See study design
What are the potential side effects?
Possible side effects of NVL-520 aren't detailed here but typically include reactions where the drug enters the body, changes in blood tests reflecting organ function, fatigue, nausea, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My advanced cancer has a confirmed ROS1 rearrangement.
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My advanced lung cancer is confirmed to have a ROS1 rearrangement.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2-3 years after first patient dosed
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2-3 years after first patient dosed for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Tolerated Dose (MTD) (Phase 1)
Objective Response Rate (ORR) (Phase 2)
Recommended Phase 2 Dose (RP2D)
Secondary outcome measures
Area under the curve at the end of the dosing interval (AUCtau) of NVL-520
Area under the curve from time 0 to 24 (AUC0-24) of NVL-520
Area under the curve from time 0 to infinity (AUCinf) of NVL-520
+18 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Phase 1 dose escalationExperimental Treatment1 Intervention
NVL-520 oral daily dosing
Group II: Cohort 2eExperimental Treatment1 Intervention
ROS1+ solid tumor and progressed on any prior therapy
Group III: Cohort 2dExperimental Treatment1 Intervention
ROS1+ NSCLC treated with ≥2 prior ROS1 TKIs and up to 1 prior chemotherapy and/or immunotherapy
Group IV: Cohort 2cExperimental Treatment1 Intervention
ROS1+ NSCLC treated with 1 prior ROS1 TKI and 1 prior platinum-based chemotherapy with or without immunotherapy
Group V: Cohort 2bExperimental Treatment1 Intervention
ROS1+ NSCLC treated with 1 prior ROS1 TKI and no prior chemotherapy or immunotherapy
Group VI: Cohort 2aExperimental Treatment1 Intervention
ROS1+ NSCLC naïve to TKI therapy and up to 1 prior chemotherapy and/or immunotherapy

Find a Location

Who is running the clinical trial?

Nuvalent Inc.Lead Sponsor
1 Previous Clinical Trials
320 Total Patients Enrolled
Vivek Upadhyay, MD, MBIStudy DirectorNuvalent Inc.
Viola Zhu, MDStudy DirectorNuvalent Inc.

Media Library

NVL-520 (ROS1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05118789 — Phase 1 & 2
Solid Tumors Research Study Groups: Cohort 2c, Cohort 2d, Cohort 2b, Phase 1 dose escalation, Cohort 2e, Cohort 2a
Solid Tumors Clinical Trial 2023: NVL-520 Highlights & Side Effects. Trial Name: NCT05118789 — Phase 1 & 2
NVL-520 (ROS1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05118789 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the key aims of this research trial?

"Nuvalent Inc., the clinical trial sponsor, has reported that their main objective for this study is to identify the Recommended Phase 2 Dose (RP2D) over a two-to-three year period. Secondary metrics include Clinical Benefit Rate (CBR), Number of participants affected by Treatment Emergent Adverse Events as per Common Terminology Criteria for Adverse Events Version 5.0, and average plasma concentration of NVL-520."

Answered by AI

How many participants are actively engaging in this clinical investigation?

"To ensure the success of this trial, 247 participants meeting specified criteria must be recruited. Nuvalent Inc., the research sponsor, will administer the experiment from multiple locations such as NYU Langone Health in New york City and Georgetown University Medical Center in Washington D.C."

Answered by AI

Are there any vacancies available to join the experiment?

"Affirmative, the information published on clinicaltrials.gov verifies that this medical trial is open for recruitment. First posted on April 1st 2022 and most recently updated October 6th 2022, 247 participants are being sought from twelve different healthcare facilities."

Answered by AI

How many facilities are providing access to this research?

"NYU Langone Health in New york, Georgetown University Medical Center in Washington D.C., UCI Medical Centre in Orange California are just a few of the 12 other locations hosting this clinical trial."

Answered by AI
~152 spots leftby Oct 2025