Study of NVL-520 for Patients with Advanced Lung Cancer and Other Solid Tumors with ROS1 Rearrangement
Sponsor: Nuvalent Inc.
ClinicalTrials ID:NCT05118789
This clinical trial is testing a new drug, NVL-520, to see if it is safe and effective for treating advanced lung cancer and other solid tumors that have a specific genetic change called ROS1 rearrangement.
Patient Parameters
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Program Overview
The study is divided into two phases. Phase 1 will focus on finding the safest dose of NVL-520 for patients with advanced solid tumors that have the ROS1 rearrangement. Phase 2 will evaluate how well the drug works in shrinking tumors in patients with advanced lung cancer and other solid tumors that are ROS1-positive. Researchers will also look at how long the treatment works, how quickly it starts to work, and overall survival rates.
Description
In Phase 2 of the study, patients will be divided into five groups based on their previous treatments:
- Group 2a: Patients with ROS1-positive lung cancer who have not received any Tyrosine Kinase Inhibitor (TKI) therapy and have had up to one prior chemotherapy or immunotherapy.
- Group 2b: Patients with ROS1-positive lung cancer who have been treated with one ROS1 TKI but no chemotherapy or immunotherapy.
- Group 2c: Patients with ROS1-positive lung cancer who have been treated with one ROS1 TKI and one platinum-based chemotherapy, with or without immunotherapy.
- Group 2d: Patients with ROS1-positive lung cancer who have been treated with two or more ROS1 TKIs and up to one prior chemotherapy or immunotherapy.
- Group 2e: Patients with ROS1-positive solid tumors other than lung cancer who have progressed after any prior therapy.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older (for Group 2e, patients can be 12 years or older and weigh more than 40 kg).
- Must have a confirmed diagnosis of advanced or metastatic solid tumor with ROS1 rearrangement.
- For Phase 2, must have advanced or metastatic lung cancer with ROS1 rearrangement (Groups 2a, 2b, 2c, 2d) or another solid tumor with ROS1 rearrangement (Group 2e).
- Must have had prior cancer treatment, except for Group 2a.
- Must have measurable disease according to specific medical criteria.
- Must have adequate organ function and bone marrow health.
Exclusion Criteria
- Cancer has a known genetic change other than ROS1.
- Known allergy to ingredients in NVL-520.
- Major surgery within four weeks before starting the study drug.
- Currently receiving other cancer treatments.
- Participating in another clinical study with active treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| UCI Medical Center | 92868 | Orange | California |
| Stanford Medicine | 94305 | Palo Alto | California |
| UC Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| University of Colorado Cancer Center | 80045 | Denver | Colorado |
| Georgetown University Medical Center | 20007 | Washington | District of Columbia |
| University of Miami | 33146 | Coral Gables | Florida |
| University of Chicago | 60637 | Chicago | Illinois |
| Mass General Hospital | 02114 | Boston | Massachusetts |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Henry Ford Cancer Institute | 48202 | Detroit | Michigan |
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