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NVL-520 for ROS1-Positive Solid Tumors
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My cancer is driven by a specific genetic change, not ROS1.I am 12 years or older and weigh more than 40 kg.My advanced cancer has a confirmed ROS1 rearrangement.My organs and bone marrow are functioning well.My cancer can be measured by standard health scans.I am allergic to ingredients in NVL-520.My cancer is advanced or has spread, and tests show a ROS1 rearrangement.My advanced lung cancer is confirmed to have a ROS1 rearrangement.I am currently receiving treatment for cancer.I am 18 years old or older.I have not had major surgery in the last 4 weeks.
- Group 1: Cohort 2c
- Group 2: Cohort 2d
- Group 3: Cohort 2b
- Group 4: Phase 1 dose escalation
- Group 5: Cohort 2e
- Group 6: Cohort 2a
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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