Camrelizumab Plus Famitinib as Treatment in Patient With Advanced or Metastatic Pulmonary Sarcomatoid Carcinoma
- Conditions
- Sarcomatoid Carcinoma of Lung
- Interventions
- Registration Number
- NCT04888429
- Lead Sponsor
- Qian Chu
- Brief 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.
- Detailed Description
This trial enrolled patients with advanced or metastatic pulmonary sarcomatoid carcinoma. Patients will receive camrelizumab 200 mg every 3 weeks and famitinib 20 mg once per day. The primary endpoint is objective response rate (ORR) assessed by investigators per RECIST version 1.1. Key secondary endpoints were progression-free survival (PFS), overall survival (OS), duration of response, and safety.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 28
- 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；
- 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 ;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Camrelizumab + Famitinib Famitinib Patients received camrelizumab 200 mg every 3 weeks and famitinib 20 mg once per day. Camrelizumab + Famitinib Camrelizumab Patients received camrelizumab 200 mg every 3 weeks and famitinib 20 mg once per day.
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) about 24 month Objective Response Rate using RECIST 1.1 criteria, Proportion of patients with CR and PR
- Secondary Outcome Measures
Name Time Method Progression-free Survival about 24 month Time from the date of first dose to first observation of progression (RECIST1.1) or date of death (from any cause)
Overall Survival about 24 month Time from the date of first dose to death from any cause
Duration of response about 24 month 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 From time of informed consent through treatment period and up to 30 days post last dose of study treatment (about 24 months) Descriptive statistics of safety will be presented using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0
Disease control rate about 24 month Disease control rate using RECIST 1.1 criteria, Proportion of patients with CR, PR and SD
Trial Locations
- Locations (8)
The first Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Henan Provincial People's Hospital
🇨🇳Zhengzhou, Henan, China
Hubei Cancer Hospital
🇨🇳Wuhan, Hubei, China
Renmin Hospital of Wuhan University Hubei General Hospital
🇨🇳Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The First Affiliated Hospital of Shandong First Medical University
🇨🇳Jinan, Shandong, China
Qian Chu
🇨🇳Wuhan, Hubei, China