Camrelizumab Plus Famitinib as Treatment in Patient With Advanced or Metastatic Pulmonary Sarcomatoid Carcinoma

• Status: Not yet recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qian Chu
• Collaborator: Jiangsu HengRui Medicine Co., Ltd.

Criteria

Inclusion Criteria:

• 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/or giant cells and/or heterogenous sarcomatous differentiation including rhabdomyosarcoma, chondrosarcoma, etc.) ；

• Has no prior systemic therapy; (chemotherapy and/or radiotherapy is allowed as part of neoadjuvant/adjuvant therapy. Patients who have had recurrence or metastasis for more than 6 months from the end of neoadjuvant/adjuvant treatment would be enrolled ) ；

• Patients must have at least one measurable lesion according to RECIST 1.1 ；

• ECOG score 0-1 ；

• Agree to provide tumour tissue samples for biomarker exploration (including but not limited to PD-L1 IHC or NGS testing) ；

• Life expectancy more than 3 months;

• Has adequate organ function；

Exclusion Criteria:

• Imaging (CT or MRI) showed tumor invasion of major vessels. hemoptysis ≥ 2.5 mL within 1 month before the first dose;

• Patients with EGFR-sensitive mutation (19Exondel/L858R), ALK, ROS1 gene rearrangement or fusion, BRAFV600E mutation, MET gene exon 14 skipping mutation;

• Patients with active bleeding or bleeding tendency ；

• With hypertension that cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure ≤ 140 mmHg/diastolic blood pressure ≤ 90 mmHg)；

• Urine protein ≥ (+ +), and 24-hour urine protein ≥ 1.0g;

• Presence of thrombotic disorder requiring anticoagulant therapy with warfarin or heparin, or requiring antiplatelet therapy (aspirin ≥ 300 mg/day or clopidogrel ≥ 75 mg/day) ；

• Has multiple factors affecting the absorption of oral drugs, such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction

• Has active central nervous system (CNS) metastases confirmed by CT or MRI

• 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/day Prednisone or equivalent);

• Has active hepatitis B ;

• Has severe infections within 4 weeks of the first dose of study treatment ;

• Women who are pregnant or lactating ;

• 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;

• Has known history of Human Immunodeficiency Virus (HIV)；

• Has known allergy to Camrelizumab, or famitinib or any of accessories ;