NVL-520 for ROS1-Positive Solid Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests NVL-520, a new drug, for safety and effectiveness in patients with advanced ROS1-positive cancers. It targets those who haven't responded well to other treatments by blocking a protein that helps cancer cells grow. NVL-520 is being tested for its effectiveness in treating advanced ROS1-positive cancers, a targetable mutation in non-small cell lung cancer (NSCLC) that has seen various treatments like crizotinib and entrectinib.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that ongoing anticancer therapy is an exclusion criterion, which might imply that you need to stop such treatments before joining.
What makes the drug NVL-520 unique for treating ROS1-positive solid tumors?
NVL-520 (Zidesamtinib) is unique because it is designed to target ROS1-positive tumors, potentially offering a new option for patients who have developed resistance to existing treatments like crizotinib, which is a common issue. This drug may provide an alternative for patients with specific mutations that make other treatments less effective.12345
What data supports the effectiveness of the drug NVL-520, Zidesamtinib for ROS1-Positive Solid Tumors?
Research on similar drugs like crizotinib and lorlatinib, which target ROS1-positive tumors, shows they can be effective in treating certain types of lung cancer by slowing tumor growth and improving patient outcomes. This suggests that NVL-520, Zidesamtinib might also be effective for ROS1-positive solid tumors.13678
Who Is on the Research Team?
Vivek Upadhyay, MD, MBI
Principal Investigator
Nuvalent Inc.
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1 Dose Escalation
Determine the recommended phase 2 dose (RP2D) and maximum tolerated dose (MTD) of NVL-520 in patients with advanced ROS1-positive solid tumors
Phase 2 Expansion
Evaluate the objective response rate (ORR) and other secondary outcomes such as duration of response (DOR), progression-free survival (PFS), and overall survival (OS) in patients with advanced ROS1-positive NSCLC and other solid tumors
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- NVL-520
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nuvalent Inc.
Lead Sponsor