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Ltd.","INDUSTRY","100430695","phase-2-camrelizumab-plus-famitinib-as-treatment-in-patient-with-advanced-or-metastatic-pulmonary-sarcomatoid-carcinoma-100430695",false,"NCT04888429","Camrelizumab Plus Famitinib as Treatment in Patient With Advanced or Metastatic Pulmonary Sarcomatoid Carcinoma","Camrelizumab Plus Famitinib as Treatment in Patient With Advanced or Metastatic Pulmonary Sarcomatoid Carcinoma：A Multi-center, Single-arm Study","CAPSTONE","Inclusion Criteria:\n\n* Patients with histologically stage IIIB, IIIC, IV Pulmonary Sarcomatoid Carcinoma according to WHO criteria or diagnosed with non-small cell lung cancer with sarcomatoid carcinoma component (sarcomatoid component tumour cells can be spindle cells, and\u002For giant cells and\u002For heterogenous sarcomatous differentiation including rhabdomyosarcoma, chondrosarcoma, etc.) ；\n* Has no prior systemic therapy; (chemotherapy and\u002For radiotherapy is allowed as part of neoadjuvant\u002Fadjuvant therapy. Patients who have had recurrence or metastasis for more than 6 months from the end of neoadjuvant\u002Fadjuvant treatment would be enrolled ) ；\n* Patients must have at least one measurable lesion according to RECIST 1.1 ；\n* ECOG score 0-1 ；\n* Agree to provide tumour tissue samples for biomarker exploration (including but not limited to PD-L1 IHC or NGS testing) ；\n* Life expectancy more than 3 months;\n* Has adequate organ function；\n\nExclusion Criteria:\n\n* Imaging (CT or MRI) showed tumor invasion of major vessels. hemoptysis ≥ 2.5 mL within 1 month before the first dose;\n* Patients with EGFR-sensitive mutation (19Exondel\u002FL858R), ALK, ROS1 gene rearrangement or fusion, BRAFV600E mutation, MET gene exon 14 skipping mutation;\n* Patients with active bleeding or bleeding tendency ；\n* With hypertension that cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure ≤ 140 mmHg\u002Fdiastolic blood pressure ≤ 90 mmHg)；\n* Urine protein ≥ (+ +), and 24-hour urine protein ≥ 1.0g;\n* Presence of thrombotic disorder requiring anticoagulant therapy with warfarin or heparin, or requiring antiplatelet therapy (aspirin ≥ 300 mg\u002Fday or clopidogrel ≥ 75 mg\u002Fday) ；\n* Has multiple factors affecting the absorption of oral drugs, such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction\n* Has active central nervous system (CNS) metastases confirmed by CT or MRI\n* Subjects diagnosed immunodeficiency or receiving systemic glucocorticoid therapy or any other form of immunosuppressive therapy of non-related tumor within 7 days before the first dose; allowed physiological dose of glucocorticoid (≤10 mg\u002Fday Prednisone or equivalent);\n* Has active hepatitis B ;\n* Has severe infections within 4 weeks of the first dose of study treatment ;\n* Women who are pregnant or lactating ;\n* With grade II or above myocardial ischemia or myocardial infarction and poorly controlled arrhythmias (QTc interval ≥ 450 ms for males and QTc interval ≥ 470 ms for females). Subjects with grade III-IV cardiac insufficiency or with left ventricular ejection fraction (LVEF) less than 50% according to NYHA criteria;\n* Has known history of Human Immunodeficiency Virus (HIV)；\n* Has known allergy to Camrelizumab, or famitinib or any of accessories ;","ALL","18 Years","75 Years",{"count":154,"type":155},28,"ESTIMATED","INTERVENTIONAL",[158],"PHASE2","This is a single arm, multi-center clinical trial. Target population is patients with Advanced or Metastatic Pulmonary Sarcomatoid Carcinoma，aiming to evaluate the efficacy and safety of the combination therapy of Camrelizumab and famitinib . Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody, and famitinib is an orally bioavailable receptor tyrosine kinase (RTK) inhibitor.",[161],"Sarcomatoid Carcinoma of Lung",[161,18,24],"2024-09-26",{"date":165,"type":166},"2024-10-01","ACTUAL",{"date":168,"type":166},"2021-07-19",{"date":170,"type":155},"2025-06-30",{"name":31,"class":6},8]