OncoMatch/Clinical Trials/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
Is NCT01639508 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Cabozantinib for non-small cell lung cancer.
Treatment: Cabozantinib — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Required: RET KIF5B/RET or related variant fusion
Group A: KIF5B/RET or related variant RET fusions
Required: NTRK1 fusion
Group B: NTRK fusion
Required: NTRK2 fusion
Group B: NTRK fusion
Required: NTRK3 fusion
Group B: NTRK fusion
Required: MET overexpression
Group B: MET overexpression
Required: MET amplification
Group B: MET amplification
Required: MET mutation
Group B: MET mutation
Required: AXL overexpression
Group B: AXL overexpression
Required: AXL amplification
Group B: AXL amplification
Required: AXL mutation
Group B: AXL mutation
Required: ROS1 fusion
Group C: ROS1 fusion
Allowed: RET fusion post-progression on selective RET inhibitor
GROUP D: RET-fusion post-progression on selective RET inhibitor
Disease stage
Metastatic disease required
Prior therapy
Cannot have received: cabozantinib (cabozantinib)
Prior treatment with cabozantinib
Cannot have received: systemic anticancer agent
Exception: within 3 weeks of first dose of study treatment, or within 5 half-lives of the agent whichever is shorter
Any type of systemic anticancer agent (including investigational) within 3 weeks of first dose of study treatment, or within 5 half-lives of the agent whichever is shorter. Subjects on LHRH or GnRH agonists may be maintained on these agents.
Lab requirements
Blood counts
ANC ≥ 1500/mm3 without colony stimulating factor support; Platelets ≥ 100,000/mm3; Hemoglobin ≥ 9 g/dL
Kidney function
Serum creatinine ≤ 1.5 × ULN or creatinine clearance (CrCl) ≥ 30 mL/min (Cockcroft and Gault equation)
Liver function
Bilirubin ≤ 1.5 × ULN (≤ 3.0 mg/dL for Gilbert's disease); ALT and AST ≤ 3.0 × ULN if no liver involvement, or ≤ 5 × ULN with liver involvement
The subject has organ and marrow function and laboratory values as follows: ... (see full criteria for details)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Memorial Sloan Kettering Basking Ridge · Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth · Middletown, New Jersey
- Memorial Sloan Kettering Bergen · Montvale, New Jersey
- Memorial Sloan Kettering Commack · Commack, New York
- Memorial Sloan Kettering Westchester · Harrison, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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