Clinical trial NCT04888429: Camrelizumab Plus Famitinib as Treatment in Patient With Advanced or Metastatic Pulmonary Sarcomatoid Carcinoma
Official title: Camrelizumab Plus Famitinib as Treatment in Patient With Advanced or Metastatic Pulmonary Sarcomatoid Carcinoma：A Multi-center, Single-arm Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Sarcomatoid Carcinoma of Lung
Keywords: Sarcomatoid Carcinoma of Lung
Camrelizumab
Famitinib
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Jiangsu HengRui Medicine Co., Ltd.
First posted: 2021-05-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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 ;

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: about 24 month
Secondary outcomes:
measure: Progression-free Survival
timeFrame: about 24 month
measure: Overall Survival
timeFrame: about 24 month
measure: Duration of response
timeFrame: about 24 month
measure: incidence, type and severity of adverse events
timeFrame: From time of informed consent through treatment period and up to 30 days post last dose of study treatment (about 24 months)
measure: Disease control rate
timeFrame: about 24 month
Other outcomes:
Locations:
city: Xiamen
country: China
facility: The first Affiliated Hospital of Xiamen University
state: Fujian
city: Zhengzhou
country: China
facility: Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Wuhan
country: China
facility: Qian Chu
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University Hubei General Hospital
state: Hubei
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University
state: Shandong
Study officials:
affiliation: Tongji Hospital
name: Qian Chu
role: PRINCIPAL_INVESTIGATOR
affiliation: Hunan Cancer Hospital
name: Lin Wu
role: PRINCIPAL_INVESTIGATOR
References: