Actively Recruiting
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
Led by Memorial Sloan Kettering Cancer Center · Updated on 2025-12-17
86
Participants Needed
7
Research Sites
730 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
E
Exelixis
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of metastatic or unresectable non-small cell lung carcinoma
- Documented gene changes: KIF5B/RET or related RET fusions, NTRK fusion, MET overexpression/amplification/mutation, AXL overexpression/amplification/mutation, ROS1 fusion, or RET-fusion after progression on selective RET inhibitor
- Age 18 years or older at consent
- Measurable disease by RECIST 1.1 criteria
- Karnofsky performance status greater than 70%
- Adequate organ and marrow function with specific laboratory value requirements
- Ability to understand and follow study protocol and provide informed consent
- Use of medically accepted barrier contraception during study and for 4 months after last dose if sexually active
- Women of childbearing potential must have a negative pregnancy test at screening
- Women of childbearing potential defined as those who have had menarche and are not surgically sterilized or postmenopausal
You will not qualify if you...
- Use of any systemic anticancer agent within 3 weeks or 5 half-lives before study drug start (except LHRH or GnRH agonists)
- Previous treatment with cabozantinib
- Radiation therapy for bone or brain metastases within 2 weeks or other external radiation within 4 weeks before study drug start
- Incomplete recovery from prior therapy toxicity except alopecia or non-clinically significant adverse events
- Uncontrolled symptomatic brain metastases or epidural disease (unless stable and not requiring medication)
- Need for therapeutic anticoagulants except low-dose aspirin or low molecular weight heparin
- Recent clinically significant bleeding or pulmonary hemorrhage within 3 months
- Radiographic evidence of cavitating lung lesions or tumor invading major blood vessels
- Evidence of endotracheal or endobronchial tumor within 28 days before treatment
- Uncontrolled significant illness including severe heart failure, uncontrolled hypertension, recent serious cardiac events, gastrointestinal disorders with high risk of perforation, active infections, non-healing wounds, history of organ transplant, thyroid dysfunction, recent major surgery with incomplete healing
- Unable to swallow tablets
- Corrected QT interval over 500 ms within 14 days before treatment
- Pregnancy or breastfeeding
- Allergy to study drug components
- Inability or unwillingness to follow study protocol
- Uncontrolled other malignancies that interfere with cabozantinib assessment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
A
Alexander Drilon, MD
CONTACT
M
Mark Kris, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here