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.
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 ；
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)；
Single group
Camrelizumab
DrugPatients received camrelizumab 200 mg every 3 weeks
Famitinib
DrugPatients received Famitinib 20 mg once per day
Objective Response Rate (ORR)
Objective Response Rate using RECIST 1.1 criteria, Proportion of patients with CR and PR
Progression-free Survival
Time from the date of first dose to first observation of progression (RECIST1.1) or date of death (from any cause)
Overall Survival
Time from the date of first dose to death from any cause
Duration of response
Time from the date of the first documented response (CR or PR) to the earliest date of disease progression (RECIST 1.1), or death due to any cause.
incidence, type and severity of adverse events
Descriptive statistics of safety will be presented using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
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Qian Chu
Lead sponsor
Tongji Hospital
Sponsor institution
Jiangsu HengRui Medicine Co., Ltd.
Collaborator
