CAPSTONE: Camrelizumab Plus Famitinib as Treatment in Patient With Advanced or Metastatic Pulmonary Sarcomatoid Carcinoma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Camrelizumab + Famitinib Patients received camrelizumab 200 mg every 3 weeks and famitinib 20 mg once per day. |
Drug: Camrelizumab
Patients received camrelizumab 200 mg every 3 weeks
Other Names:
Drug: Famitinib
Patients received Famitinib 20 mg once per day
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Objective Response Rate (ORR) [about 24 month]
Objective Response Rate using RECIST 1.1 criteria
Secondary Outcome Measures
- Progression-free Survival [about 24 month]
Time from enrollment to first observation of progression (RECIST1.1) or date of death (from any cause)
- Overall Survival [about 24 month]
Time from enrollment until death due to any cause
- Duration Response Rate [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.) ；
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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 ) ；
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Patients must have at least one measurable lesion according to RECIST 1.1 ；
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ECOG score 0-1 ；
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Agree to provide tumour tissue samples for biomarker exploration (including but not limited to PD-L1 IHC or NGS testing) ；
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Life expectancy more than 3 months;
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Has adequate organ function；
Exclusion Criteria:
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Imaging (CT or MRI) showed tumor invasion of major vessels. hemoptysis ≥ 2.5 mL within 1 month before the first dose;
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Patients with EGFR-sensitive mutation (19Exondel/L858R), ALK, ROS1 gene rearrangement or fusion, BRAFV600E mutation, MET gene exon 14 skipping mutation;
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Patients with active bleeding or bleeding tendency ；
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With hypertension that cannot be reduced to the normal range after antihypertensive drug treatment (systolic blood pressure ≤ 140 mmHg/diastolic blood pressure ≤ 90 mmHg)；
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Urine protein ≥ (+ +), and 24-hour urine protein ≥ 1.0g;
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Presence of thrombotic disorder requiring anticoagulant therapy with warfarin or heparin, or requiring antiplatelet therapy (aspirin ≥ 300 mg/day or clopidogrel ≥ 75 mg/day) ；
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Has multiple factors affecting the absorption of oral drugs, such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction
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Has active central nervous system (CNS) metastases confirmed by CT or MRI
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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);
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Has active hepatitis B ;
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Has severe infections within 4 weeks of the first dose of study treatment ;
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Women who are pregnant or lactating ;
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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;
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Has known history of Human Immunodeficiency Virus (HIV)；
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Has known allergy to Camrelizumab, or famitinib or any of accessories ;
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Qian Chu
- Jiangsu HengRui Medicine Co., Ltd.
Investigators
- Principal Investigator: Qian Chu, Tongji Hospital
- Principal Investigator: Lin Wu, Hunan Cancer Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- S037