Cabozantinib for Advanced Non-Small Cell Lung Cancer with Specific Gene Changes
This study is testing cabozantinib (XL184) in people with advanced non-small cell lung cancer that has spread or cannot be removed by surgery. You might be eligible if your cancer has specific gene changes, such as RET, ROS1, or NTRK fusions, or increased MET or AXL activity. Cabozantinib is an oral medicine that works by blocking these gene changes and other pathways that help cancer grow and spread. The main goal is to see how many patients respond to the treatment (objective response rate) after 12 weeks. This is a Phase II study, which means it's looking at how effective cabozantinib is and what side effects it might have. The study plans to enroll 86 participants.
- Study design
- This is an interventional Phase II study that plans to enroll 86 participants. It is looking at the effects of cabozantinib in two groups based on specific gene changes in their cancer.
- What's involved
- Participants will take cabozantinib orally at a dose of 60 mg daily, continuously for 28-day cycles. Doses may be adjusted if you experience side effects.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary outcome of how well the treatment works (objective response rate) will be measured at 12 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT01639508
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
Recruiting
PHASE2Ages 18+InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~86 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:Cabozantinib
At a glance
Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
objective response rate (ORR) (Group A)
Measured over 12 weeks
+1 more outcome measured
Conditions
Where it's being run
7 sites across 2 statesNew York4
New Jersey3
Study leadership
- Alexander Drilon, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
Alexander Drilon, MD
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Exclusion
clinically-significant hematemesis or gastrointestinal bleeding
Clinically-significant hemoptysis of ≥ 0.5 teaspoon (2.5ml) of red blood c. any other signs indicative of pulmonary hemorrhage 8. The subject has radiographic evidence of cavitating pulmonary lesion(s) 9. The subject has tumor in contact with invading major blood vessels 10. The subject has any evidence of an endotracheal or endobronchial tumor within 28 days before the first dose of cabozantinib. 11. The subject has uncontrolled, significant intercurrent or recent illness including, but not limited to, the following conditions:
Cardiovascular disorders including Congestive heart failure (CHF): New York Heart Association (NYHA) Class III (moderate) or Class IV (severe) at the time of screening
Concurrent uncontrolled hypertension defined as sustained BP ≥ 150 mm Hg systolic, or ≥ 90 mm Hg diastolic despite optimal antihypertensive treatment (Note: If there is any BP measurement that is performed within the screening period that is \< 150 mm Hg systolic and \<90 mm Hg diastolic, then BP does not meet definition of sustained.)
Any of the following within 6 months before the first dose of study treatment:
unstable angina pectoris
clinically-significant cardiac arrhythmias
stroke (including TIA, or other ischemic event) myocardial infarction
thromboembolic event requiring therapeutic anticoagulation except if anticoagulation is as stipulated in Exclusion Criterium #6. (Note: subjects with a venous filter (e.g. vena cava filter) are not eligible for this study)
Gastrointestinal disorders particularly those associated with a high risk of perforation or fistula formation including:
Any of the following within 28 days before the first dose of study treatmentF
intra-abdominal tumor/metastases invading GI mucosa (malignant abdominal ascites does not constitute mucosal invasion)
active peptic ulcer disease,
inflammatory bowel disease (including ulcerative colitis and Crohn's disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis
malabsorption syndrome
Any of the following within 6 months before the first dose of study treatment:
history of abdominal fistula
gastrointestinal perforation
bowel obstruction or gastric outlet obstruction
intra-abdominal abscess. Note: Complete resolution of an intra-abdominal abscess must be confirmed prior to initiating treatment with cabozantinib even if the abscess occurred more that 6 months ago. GI surgery (particularly when associated with delayed or incomplete healing) within 28 days. Note: Complete healing following abdominal surgery must be confirmed prior to initiating treatment with cabozantinib even if surgery occurred more that 28 days ago.
Other disorders associated with a high risk of fistula formation including PEG tube placement within 3 months before the first dose of study therapy or concurrent evidence of intraluminal tumor involving the trachea and esophagus.
Other clinically significant disorders such as:
active infection requiring systemic treatment within 28 days before the first dose of study treatment
serious non-healing wound/ulcer/bone fracture within 28 days before the first dose of study treatment
history of organ transplant
concurrent uncompensated hypothyroidism or thyroid dysfunction within 7 days before the first dose of study treatment
Major surgery (eg, thoracotomy, removal or biopsy of brain metastasis) within 3 months before Week 1 Day 1. Complete wound healing from major surgery must have occurred 1 month before Week 1 Day 1 and from minor surgery (eg, simple excision, tooth extraction) at least 10 days before Week 1 Day 1. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.
history of major surgery as follows: 12. The subject is unable to swallow tablets 13. The subject has a corrected QT interval calculated by the Fridericia formula (QTcF) \> 500 ms 14 days before Week 1 Day 1 14. The subject is pregnant or breastfeeding. 15. The subject has a previously identified allergy or hypersensitivity to components of the study treatment formulation. 16. The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee. 17. Uncontrolled concurrent malignancy that would limit assessment of efficacy of cabozantinib.
What this trial measures
- objective response rate (ORR) (Group A)12 weeks
by RECIST v1.1 criteria to cabozantinib in patients with advanced NSCLC who have tested positive for RET Fusion
- objective response rate (ORR) (Group B)12 weeks
by RECIST v1.1 criteria to cabozantinib in patients with advanced NSCLC whose tumors test positive for a ROS1 or NTRK fusion or MET or AXL overexpression, amplification, or mutation.