Phase II study to evaluate the activity and safety of Cabozantinib in pretreated, advanced RET-reArranged non-small cell lung cancer patients: CRETA trial - CRETA

Overview

No summary available.

Registry

who.int

Start Date

August 3, 2021

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\.Locally advanced, relapsed or metastatic non\-small cell lung cancer – stage IIIB/IV according to 7th International Association for the Study of Lung Cancer (IASLC) classification ¿
•2\.Ability to understand and willingness to sign informed consent prior to initiation of any study procedures. ¿
•3\.Pathologically (histology or cytology) confirmed diagnosis of non\- small cell lung carcinoma. ¿
•4\.RET gene rearrangement by local laboratory analysis with an approved standard method (FISH or Next Generation Sequencing Panel). An archival tumor sample must be available for central laboratory confirmation. ¿
•5\.Male or female and \= 18 years of age ¿
•6\.Life expectancy \= 12 weeks ¿
•7\.Have progressed after or during at least one standard anticancer ¿
•8\.Have measurable disease as per Response Evaluation Criteria in ¿Solid Tumors, version 1\.1 (RECIST 1\.1\); clear radiological evidence of disease progression after first\-line therapy must be documented; no previous radiotherapy on the only site of measurable or evaluable disease, unless that site had subsequent evidence of progression ¿
•9\.Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1
•10\.Subjects must have adequate organ function including the following:

•1\.Radiation therapy for bone metastasis within 2 weeks, any other external radiation therapy within 4 weeks before randomization. Systemic treatment with radionuclides within 6 weeks before randomization. Subjects with clinically relevant ongoing complications from prior radiation therapy are not eligible.
•2\.Previous treatment with cabozantinib. ¿
•3\.Gastrointestinal disorders likely to interfere with absorption of the study drug.
•4\.Subjects with gastrointestinal disorders associated with a high risk of perforation of fistula formation.
•5\.Subjects with active peptic ulcer or with a history of clinically ¿significant GI bleeding within 6 months before the first dose of study treatment.
•6\.Patients requiring full\-dose anticoagulation therapy any time prior to enrollment.
•7\.Current use of aspirin, clopidogrel, ticlopidine.
•8\.Patients with tumors invading major pulmonary vessels and/or with cavitating pulmonary lesions.
•9\.Major surgery within the last four weeks. Complete wound healing from major surgery must have occurred 1 month before randomization and from minor surgery at least 10 days before randomization. Subjects with clinically relevant ongoing complications from prior surgery are not eligible.
•10\.Subjects with clinical or radiological signs of pulmonary hemorrhage within 3 months before the first dose of study treatment.