At a glance
ClinicalIndex Comparison Record- ✓Pathologic diagnosis of metastatic or unresectable NSCLC
- ✓KIF5B/RET or related RET fusion variant (Group A)
- ✓NTRK fusion, MET overexpression/amplification/mutation, or AXL overexpression/amplification/mutation (Group B)
- ✓ROS1 fusion (Group C)
- ✕Prior treatment with cabozantinib
- ✕Systemic anticancer agent within 3 weeks or 5 half-lives (whichever shorter)
- ✕Radiation therapy for bone/brain metastasis within 2 weeks; other external radiation within 4 weeks; systemic radionuclides within 4 weeks
- ✕Not recovered to baseline or CTCAE Grade 1 from prior therapy toxicity (except alopecia)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Cabozantinib for Non-Small Cell Lung Cancer. Currently recruiting, targeting 86 participants across 7 sites.
Detailed 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.
Study Details
Timeline
Interventions
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.