359 Participants Needed

NVL-520 for ROS1-Positive Solid Tumors

Recruiting at 64 trial locations
GR
N
Overseen ByNuvalent
Age: Any Age
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: Nuvalent Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

VU

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

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.
See 4 more

Exclusion Criteria

My cancer is driven by a specific genetic change, not ROS1.
I am allergic to ingredients in NVL-520.
Actively receiving systemic treatment or direct medical intervention on another therapeutic clinical study
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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

Approximately 4-8 weeks

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

2-3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 3 years

What Are the Treatments Tested in This Trial?

Interventions

  • NVL-520
Trial Overview 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.
How Is the Trial Designed?
6Treatment groups
Experimental Treatment
Group I: Phase 1 dose escalationExperimental Treatment1 Intervention
Group II: Cohort 2eExperimental Treatment1 Intervention
Group III: Cohort 2dExperimental Treatment1 Intervention
Group IV: Cohort 2cExperimental Treatment1 Intervention
Group V: Cohort 2bExperimental Treatment1 Intervention
Group VI: Cohort 2aExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Nuvalent Inc.

Lead Sponsor

Trials
6
Recruited
1,400+

Published Research Related to This Trial

ROS1 fusion events occur in 1%-2% of non-small-cell lung cancer (NSCLC) patients and are associated with specific patient demographics, including younger individuals, women, and non-smokers, indicating a distinct molecular subtype of NSCLC.
Crizotinib is the only approved treatment for ROS1-rearranged NSCLC, showing significant benefits in progression-free survival and quality of life, and is recommended as the standard first-line therapy for patients with this genetic alteration.
Crizotinib inhibition of ROS1-positive tumours in advanced non-small-cell lung cancer: a Canadian perspective.Bebb, DG., Agulnik, J., Albadine, R., et al.[2023]
In a study of 80 patients with advanced ROS1+ non-small-cell lung cancer (NSCLC), lorlatinib demonstrated a median progression-free survival of 7.1 months and an overall survival of 19.6 months, indicating its efficacy as a treatment option.
The treatment showed a high central nervous system response rate of 72% and an overall response rate of 45%, with a manageable safety profile, as 13% of patients discontinued due to toxicity, consistent with previous studies.
Lorlatinib for advanced ROS1+ non-small-cell lung cancer: results of the IFCT-1803 LORLATU study.Girard, N., Galland-Girodet, S., Avrillon, V., et al.[2022]
ROS1 translocations occur in 1-2% of all non-small cell lung cancer (NSCLC) cases and 3-6% of pulmonary adenocarcinoma cases, and can be detected using in situ hybridization techniques.
Treatment with the ROS1 inhibitor crizotinib shows a high response rate of 70-80% and a median progression-free survival of about 19 months, indicating that targeted therapy is effective and generally well tolerated for patients with ROS1-positive NSCLC.
[ROS1-Translocations in Non-Small Cell Lung Cancer].Warth, A., Weichert, W., Reck, M., et al.[2016]

Citations

Crizotinib inhibition of ROS1-positive tumours in advanced non-small-cell lung cancer: a Canadian perspective. [2023]
Lorlatinib for advanced ROS1+ non-small-cell lung cancer: results of the IFCT-1803 LORLATU study. [2022]
[ROS1-Translocations in Non-Small Cell Lung Cancer]. [2016]
Real-World Management and Outcomes of Crizotinib-Treated ROS1-Rearranged NSCLC: A Retrospective Canadian Cohort. [2022]
Short-term response to immune-chemotherapy and immune features of a ceritinib-resistant patient with ROS1-rearranged lung adenocarcinoma. [2022]
The frequency and impact of ROS1 rearrangement on clinical outcomes in never smokers with lung adenocarcinoma. [2020]
The new-generation selective ROS1/NTRK inhibitor DS-6051b overcomes crizotinib resistant ROS1-G2032R mutation in preclinical models. [2021]
Safety but Limited Efficacy of Ensartinib in ROS1-Positive NSCLC: A Single-Arm, Multicenter Phase 2 Study. [2021]
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