RecruitingPhase 2NCT01639508

Cabozantinib in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer and Those With Other Genotypes: ROS1 or NTRK Fusions or Increased MET or AXL Activity

A Phase II Study of Cabozantinib in Patients With RET Fusion-Positive Advanced Non-Small Cell Lung Cancer and Those With Other Genotypes: ROS1 or NTRK Fusions or Increased MET or AXL Activity

Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

86 participants

Start Date

Jul 1, 2012

Study Type

INTERVENTIONAL

Conditions

Non-small Cell Lung Cancer

Summary

The purpose of this phase II study is to find out what effects cabozantinib (XL184) has, good and/or bad, in patients whose tumors one of the following gene changes RET, ROS1, or NTRK fusion, or increased MET or AXL activity. A phase II study looks at how effective a medication is at treating a specific type of cancer and collects information on the side effects of the study treatment. RET, ROS1, or NTRK fusion or increased MET or AXL activity gene leads to lung cancer cell growth. Cabozantinib is an oral medicine that inhibits of RET, ROS1, NTRK, MET, and AXL. In addition, this drug interferes with other cell pathways that also cause cancer cells to grow, form new blood vessels, and spread to other organs of the body. The goal of using cabozantinib is to shrink the cancer and to prevent it from growing Cabozantinib has been studied and shown to cause cancer shrinkage in other cancers such as medullary thyroid cancer and prostate cancer. We thus have a good idea of what side-effects it causes and can anticipate them.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing cabozantinib — a drug that blocks signals that help cancer cells grow — in patients with advanced non-small cell lung cancer whose tumors carry specific genetic abnormalities such as RET, ROS1, or NTRK gene fusions, or overactivity of the MET or AXL proteins. **You may be eligible if...** - You are 18 or older - You have been diagnosed with advanced or inoperable non-small cell lung cancer (NSCLC) - Your tumor has been tested and found to carry one of the following genetic changes: a RET gene fusion, a ROS1 fusion, an NTRK fusion, overexpression or amplification of MET or AXL, or a RET fusion after progression on a selective RET inhibitor **You may NOT be eligible if...** - Your lung cancer does not have one of the qualifying genetic changes - You have small cell lung cancer (a different type) - You have serious health problems that would make taking this drug unsafe - You have had prior treatment with cabozantinib Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCabozantinib

Patients will receive cabozantinib at an initial dose of 60 mg orally daily. The drug is taken continuously over a period of 28 days (4 weeks), which constitutes one treatment cycle. Dose modifications for drug toxicity are permitted as per a prescribed algorithm. During the Treatment Period subjects will receive cabozantinib until either disease progression, the occurrence of unacceptable drug-related toxicity or for other reason(s) for subject withdrawal.