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    The study has been updated to version v2.10.0 and now includes 7 locations, replacing the previous version v2.9.7.
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    The value 2023-06-26 2023-06-23 Last Update Posted 2023-06-26 2023-06 Revision: v2.9.1 has recently changed to 2024-06-25 2024-06-24 Last Update Posted (Estimated) 2024-06-25 2024-06 Revision: v2.9.3. This change represents an update in the last posted date and revision version of the study record on the webpage.
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    32 days ago
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    Summary
    The value 'Show more Show more Revision: v2.9.0' has been updated to 'Show less MedlinePlus Genetics related topics: Lung cancer MedlinePlus related topics: Lung Cancer Drug Information available for: Cabozantinib FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : N/A Interventional Model : Single Group Assignment Masking : None (Open Label) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : Cabozantinib This will be a single-institution, open label, two-stage, single agent trial of cabozantinib in patients with advanced NSCLCs.atients in GROUP A will have tumors with a RET fusion. Patients in GROUP B will have tumors with an NTRK fusion, or MET or AXL overexpression, amplication, or mutatation. Patients in GROUP C will have tumors with a ROS1 fusion. Patients in GROUP D will have tumors with a RET fusion and have progressed on a selective RET TKI. Drug : Cabozantinib 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. Primary Outcome Measures Outcome Measure Measure Description Time Frame objective response rate (ORR) (Group A) by RECIST v1.1 criteria to cabozantinib in patients with advanced NSCLC who have tested positive for RET Fusion 12 weeks objective response rate (ORR) (Group B) 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. 12 weeks Secondary Outcome Measures Outcome Measure Measure Description Time Frame progression-free survival (PFS) (Group A) Progression-free (PFS) and overall survival (OS) will be calculated using Kaplan-Meyer estimators starting from the time of treatment initiation. For PFS, patients alive without evidence of progression at the end of the study will be censored at the time of the last available follow-up. For OS, patients alive at the end of the study will be censored at the time of the last available follow-up. 3 years overall survival (OS) (Group A) Progression-free (PFS) and overall survival (OS) will be calculated using Kaplan-Meyer estimators starting from the time of treatment initiation. For PFS, patients alive without evidence of progression at the end of the study will be censored at the time of the last available follow-up. For OS, patients alive at the end of the study will be censored at the time of the last available follow-up. 3 years safety (Group A, B, C & D) Observed toxicities will be individually tabulated according to CTCAE version 4.0 and summarized using descriptive statistics. 3 years progression-free survival (PFS) (Group B, C & D) Progression-free (PFS) and overall survival (OS) will be calculated using Kaplan-Meyer estimators starting from the time of treatment initiation. For PFS, patients alive without evidence of progression at the end of the study will be censored at the time of the last available follow-up. For OS, patients alive at the end of the study will be censored at the time of the last available follow-up with advanced NSCLCs whose tumors test positive for a ROS1 or NTRK fusion or MET or AXL overexpression or amplification who were treated with cabozantinib. 3 years overall survival (OS) (Group B, C & D) Progression-free (PFS) and overall survival (OS) will be calculated using Kaplan-Meyer estimators starting from the time of treatment initiation. For PFS, patients alive without evidence of progression at the end of the study will be censored at the time of the last available follow-up. For OS, patients alive at the end of the study will be censored at the time of the last available follow-up with advanced NSCLCs whose tumors test positive for a ROS1 or NTRK fusion or MET or AXL overexpression or amplification who were treated with cabozantinib. 3 years Other Outcome Measures Outcome Measure Measure Description Time Frame objective response rate (ORR) (Group D) by RECIST v1.1 criteria to cabozantinib in patients with advanced NSCLC who have tested positive for RET Fusion 12 weeks Keywords Provided by Memorial Sloan Kettering Cancer Center Lung XL184 (CABOZANTINIB) KIF5B/RET Positive RET Fusion Positive 12-097 Genotypes: ROS1 or NTRK Fusions or Increased MET or AXL Activity Additional Relevant MeSH Terms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Lung Neoplasms Carcinoma, Non-Small-Cell Lung Helpful Links Provided by Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center Revision: v2.9.1'
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