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

Официальное название

Camrelizumab Plus Famitinib as Treatment in Patient With Advanced or Metastatic Pulmonary Sarcomatoid Carcinoma：A Multi-center, Single-arm Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Camrelizumab
  Patients received camrelizumab 200 mg every 3 weeks
• Препарат Famitinib
  Patients received Famitinib 20 mg once per day

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: about 24 month]

Вторичные конечные точки (5)

• Progression-free Survival [Срок оценки: about 24 month]
• Overall Survival [Срок оценки: about 24 month]
• Duration of response [Срок оценки: about 24 month]
• incidence, type and severity of adverse events [Срок оценки: From time of informed consent through treatment period and up to 30 days post last dose of study treatment (about 24 months)]
• Disease control rate [Срок оценки: about 24 month]

Критерии участия

Критерии включения

• 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；

Критерии исключения

• 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 ;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 8 центров

• The first Affiliated Hospital of Xiamen University — Xiamen
• Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University — Чжэнчжоу
• Henan Provincial People's Hospital — Чжэнчжоу
• Qian Chu — Ухань
• Hubei Cancer Hospital — Ухань
• Renmin Hospital of Wuhan University Hubei General Hospital — Ухань
• The Second Xiangya Hospital of Central South University — Чанша
• The First Affiliated Hospital of Shandong First Medical University — Цзинань

Идентификаторы

NCT: NCT04888429 · S037

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗