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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sarcomatoid Carcinoma of Lung
• Intervention / Treatment: Drug: Camrelizumab; Drug: Famitinib

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 Type: Interventional
• Enrollment (Estimated): 28
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Qian Chu; Phone Number: +86 13212760751; Email: qianchu@163.com
• Study Contact Backup: Name: Lin Wu; Phone Number: +86 13170419973; Email: wulin-calf@vip.163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Qian Chu
      • Contact: Qian Chu; Phone Number: +86 13212760751; Email: qianchu@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 ;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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: SHR-1210; Drug: Famitinib; Patients received Famitinib 20 mg once per day; Other Names: SHR-1020

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	Objective Response Rate using RECIST 1.1 criteria	about 24 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival	Time from enrollment to first observation of progression (RECIST1.1) or date of death (from any cause)	about 24 month
Overall Survival	Time from enrollment until death due to any cause	about 24 month
Duration Response Rate	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.	about 24 month
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	From time of informed consent through treatment period and up to 30 days post last dose of study treatment (about 24 months)

Collaborators and Investigators

• Sponsor: Qian Chu
• Collaborators: Jiangsu HengRui Medicine Co., Ltd.
• Investigators: Principal Investigator: Qian Chu, Tongji Hospital; Principal Investigator: Lin Wu, Hunan Cancer Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2021
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: May 12, 2021
• First Submitted That Met QC Criteria: May 12, 2021
• First Posted (Actual): May 17, 2021

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 23, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Famitinib; Camrelizumab; Sarcomatoid Carcinoma of Lung
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma
• Other Study ID Numbers: S037

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No