BridgeMD
Phase II single arm study with CABozantinib in Non-Small Cell Lung Cancer patients with MET deregulation
EU CTIS ID: 2024-518386-95-02
What this study is testing
To evaluate the efficacy in term of response rate (RR) of Cabozantinib in NSCLC patients with MET amplification or MET exon 14 Skippin mutation pretreated or not with MET inhibitors
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Citological or histological diagnosis of non-small-cell-lung cancer (NSCLC) stage III B (not suitable for local treatments with curative intent) or stage IV. 2. Tissue samples available for MET analysis (archivial tissue or tissue collected at study entry); patients without archival tumor tissue or refusing new biopsy at study entry, are eligible if MET mutation is detected in cf-DNA 3. Presence of MET mutations (exon 14 skipping mutation ONLY) detected in tissue or in cf-DNA detected at the local lab or MET amplification (MET/CEP7 ratio > 2.2) detected in the central lab ONLY. 4. Measurable disease according to RECIST criteria version 1.1 5. At least 1 prior line of standard therapy (chemotherapy and/ or immunotherapy) 6. Performance status 0-1 (ECOG) 7. Age ≥18 years 8. Patients potentially fertile using adequate methods of contraception in order to avoid childbearing. Contraceptive methods must be respected by male and female patients and their partners during study treatment period and at least 4 months after completing therapy 9. Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to enrollment: a. ANC ≥ 1500 cells/μL without granulocyte colony-stimulating factor support b. Platelet count ≥ 100,000/μL without transfusion c. Hemoglobin ≥ 9.0 g/dL Patients may be transfused to meet this criterion d. AST, ALT, and alkaline phosphatase ≤ 2.5 × ULN, with the following exceptions: - Patients with documented liver metastases: AST and/or ALT ≤ 5 × ULN - Patients with documented liver or bone metastases: alkaline phosphatase ≤ 5 × ULN. e. Serum bilirubin ≤ 1.25 × ULN f. Patients with known Gilbert disease who have serum bilirubin level ≤ 3 mg/dL may be enrolled g. Calculated creatinine clearance (CRCL) ≥ 45 mL/min or calculated CRCL must be ≥ 60 mL/min 10. Patient compliance to the study procedure 11. Written informed consent
You likely can't join if
- 1. Tissue sample not available for the central assessing of MET amplification 2. No possibility to assess MET status 3. Absence of any measurable disease according to RECIST criteria 4. Co-existence of driver events, including EGFR mutations, KRAS mutations, ALK rearrangements or ROS-1 rearrangements 5. No prior therapy 6. Concomitant chemotherapy or immunotherapy or radiotherapy 7. Symptomatic brain metastasis 8. Uncontrolled significant inter-current or recent illness, including cardiovascular disorders and gastro-intestinal disorders 9. Major surgery within 2 months before first dose of study treatment 10. Concomitant anti-coagulation with oral anti-coagulants or plated inhibitors 11. History of significant bleeding, trachea-bronchial tree/major blood vessels invading tumors, cavity pulmonary lesions and GI disorders associated with a risk of perforation or fistula formation 12. Diagnosis of another cancer in the last 3 years, except for in situ carcinoma of cervix, breast and bladder or skin carcinoma (squamous or basalioid) 13. Pregnancy or breastfeeding
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.