Condition: Locally Advanced Solid Tumor · Metastatic Solid Tumor · Sponsor: Nuvalent Inc.
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.
This description comes directly from the study's public registry record.
Nuvalent · 857-357-7000 · clinicaltrials@nuvalent.com
Always discuss trial participation with your own doctor first.
| UCI Medical Center | Orange, California, United States | Recruiting |
| Stanford Medicine | Palo Alto, California, United States | Recruiting |
| UC Davis Comprehensive Cancer Center | Sacramento, California, United States | Recruiting |
| University of Colorado Cancer Center | Denver, Colorado, United States | Recruiting |
| Georgetown University Medical Center | Washington D.C., District of Columbia, United States | Recruiting |
| University of Miami | Coral Gables, Florida, United States | Recruiting |
| University of Chicago | Chicago, Illinois, United States | Recruiting |
| Mass General Hospital | Boston, Massachusetts, United States | Recruiting |
| Dana-Farber Cancer Institute | Boston, Massachusetts, United States | Recruiting |
| Henry Ford Cancer Institute | Detroit, Michigan, United States | Recruiting |
| Washington University School of Medicine | St Louis, Missouri, United States | Recruiting |
| NYU Langone Health | New York, New York, United States | Recruiting |
+ 51 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT05118789