non-small cell lung cancer
Conditions
Interventions
Stage 1: Befotertinib monotherapy:Befotertinib for the treatment of patients with EGFR sensitive mutations in locally advanced or metastatic NSCLC
Stage 1: Befotertinib combined with Rivaroxaban:Befotertinib combined with Rivaroxaban for the treatment of patients with EGFR sensitive mutations in locally advanced or metastatic NSCLC
introduction period:Befotertinib combined with Rivaroxaban for the treatment of patients with EGFR sensitive mutations in locally advanced or metastatic NSCLC
Stage 2:Based on the results of Phase 1, the long-term safety and efficacy of befotertinib will be evaluated in a larger population of potential beneficiaries (individuals at low risk of VTE and/or th
Sponsors
National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily sign a written informed consent form, capable of understanding and complying with the trial protocol requirements. 2. Adult patients aged >=18 years at the time of signing the informed consent form. 3. Patients currently receiving befditinib as first-line/second-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC). Patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), defined as: histologically or cytologically confirmed locally advanced (AJCC 8th edition stage IIIB and IIIC) or metastatic lung adenocarcinoma (AJCC 8th edition stage IV), not suitable for radical surgery or radiotherapy. Mixed histology with predominant adenocarcinoma component is acceptable. For first-line treatment, defined as: patients with EGFR-sensitive mutations (exon 19 deletion or exon 21 L858R mutation, either alone or coexisting with other EGFR site mutations) confirmed by laboratory testing, who have not previously received systemic treatment. For second-line treatment, defined as: treatment for patients who have experienced disease progression during or after EGFR-TKI therapy and have developed EGFR T790M mutation. 4. Expected survival period of at least 6 months. 5. Voluntary agreement to use highly effective contraception throughout the study period and for at least 3 months after the last dose of the study drug [For women: Oral, injectable, or implanted hormonal contraception; Intrauterine device or intrauterine system; Barrier methods: condoms or occlusive caps (diaphragm or cervical/vault cap) with spermicide. For men: Condoms with spermicide; Surgical sterilization (e.g., bilateral orchiectomy, bilateral vasectomy)]; premenopausal women with childbearing potential (defined as meeting the following criteria: 1. No bilateral tubal ligation, hysterectomy, or bilateral oophorectomy; Last menstrual period to screening <2 years) must be excluded if pregnant. 6. All patients must agree to refrain from donating blood, sperm, or eggs during treatment with the study drug and for at least 3 months after the last dose.
Exclusion criteria
Exclusion criteria: 1. Concurrent other malignant tumors. Note: Exceptions include clinically cured carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, and papillary thyroid carcinoma. 2. Significant worsening of symptoms or signs within 2 weeks before screening (e.g., massive pleural effusion within 2 weeks before screening may be considered for screening after the effusion is controlled), as judged by the investigator to be unsuitable for trial participation. 3. Patients with active infections (such as hepatitis B, hepatitis C, syphilis, HIV antibody positive), as well as systemic infections requiring hospitalization. Note: Definition of active hepatitis B: HBsAg positive with HBV DNA levels above or equal to the lower limit of detection (based on local laboratory reference values). Definition of active hepatitis C: HCV Ab positive with HCV RNA positive (based on local laboratory reference values). 4. Current presence of any arterial, venous thromboembolism or microangiopathy (e.g., patients with antiphospholipid syndrome). 5. Patients with congenital long QT syndrome. 6. Patients judged by the investigator to have contraindications for rivaroxaban anticoagulation therapy, including but not limited to: History of central nervous system hemorrhage, intracranial or spinal high-risk bleeding lesions within 3 months prior to screening; Active bleeding (major bleeding): Transfusion of more than 2 units within 24 hours; Patients with CAD (coronary artery disease) or PAD (peripheral artery disease) who have experienced hemorrhagic stroke or lacunar stroke, or any stroke within the past 1 month; Lesions or conditions with significant risk of major bleeding (current or within 3 months prior to screening): Active gastrointestinal ulcers, other gastrointestinal disorders without active ulcers but capable of causing bleeding complications (e.g., inflammatory bowel disease, esophagitis, gastritis, and gastroesophageal reflux disease), occurrence of brain or spinal injury, undergoing brain, spinal or eye surgery, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracranial vascular malformations, congenital or acquired bleeding disorders, uncontrolled severe hypertension, vascular retinopathy; history of bronchiectasis or pulmonary hemorrhage; Patients with severe renal impairment (creatinine clearance 3 times ULN; Decreased platelet count to <25×10?/L; Patients with prosthetic heart valves. 7. Patients who are currently using any other anticoagulants (unfractionated heparin (UFH), low molecular weight heparin (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), oral anticoagulants (warfarin, apixaban, dabigatran, etc.)) and/or antiplatelet therapy. 8. Use of potent P-glycoprotein (P-gp) and CYP3A4 inducers/inhibitors within 2 weeks prior to the first administration of the investigational drug. Note: P-gp and CYP3A4 inducers include but are not limited to: rifampin/rifamycin, rifabutin, rifapentine, phenytoin, phenobarbital, carbamazepine, or St. John's wort. P-gp and potent CYP3A4 inhibitors include but are not limited to: ritonavir, ketoconazole, itraconazole, voriconazole, and posaconazole. 9. History of or suspected allergic symptoms to any component of the investigational drugs beflotinib or rivaroxaban. 10. Participation in another clinical trial of drugs or medical device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of venous thromboembolism (VTE) was observed in both the Befotertinib monotherapy group and the Befotertinib combined with prophylactic anticoagulation group.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of bleeding events; | — |
Countries
China
Contacts
Public ContactJianchun Duan
Chinese Academy of Medical Sciences and Peking Union Medical College
Outcome results
None listed