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

NCT04888429 | Recruiting Phase 2

• 1 other identifier: S037
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 8

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.

Conditions

Sarcomatoid Carcinoma of Lung

Keywords

Sarcomatoid Carcinoma of Lung; Camrelizumab; Famitinib

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Objective Response Rate using RECIST 1.1 criteria, Proportion of patients with CR and PR

  about 24 month

Secondary Outcomes (5)

• Progression-free Survival

  about 24 month

• Overall Survival

  about 24 month

• Duration of response

  about 24 month

• 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)

• Disease control rate

  about 24 month

Study Arms (1)

Camrelizumab + Famitinib

EXPERIMENTAL

Patients received camrelizumab 200 mg every 3 weeks and famitinib 20 mg once per day.

Drug: Camrelizumab; Drug: Famitinib

Interventions

Camrelizumab DRUG

Patients received camrelizumab 200 mg every 3 weeks

Also known as: SHR-1210

Camrelizumab + Famitinib

Famitinib DRUG

Patients received Famitinib 20 mg once per day

Also known as: SHR-1020

Camrelizumab + Famitinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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；

You may not qualify if:

• 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 ;

Sponsors & Collaborators

• Qian Chu: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (8)

The first Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

ACTIVE NOT RECRUITING

Henan Cancer Hospital Affiliated Cancer Hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

Henan Provincial People's Hospital

Zhengzhou, Henan, China

RECRUITING

Qian Chu

Wuhan, Hubei, 430000, China

RECRUITING

Hubei Cancer Hospital

Wuhan, Hubei, China

RECRUITING

Renmin Hospital of Wuhan University Hubei General Hospital

Wuhan, Hubei, China

RECRUITING

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China

ACTIVE NOT RECRUITING

MeSH Terms

Interventions

camrelizumab; famitinib

Study Officials

• Qian Chu

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

• Lin Wu

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian Chu

CONTACT

13212760751; qianchu@163.com

Lin Wu

CONTACT

13170419973; wulin-calf@vip.163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 17, 2021
• Study Start: July 19, 2021
• Primary Completion: December 30, 2024
• Study Completion: June 30, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Locations

CN (8)