A Trial of Camrelizumab Combined With Famitinib Malate in Treatment Naïve Subjects With PD-L1-Positive Recurrent or Metastatic Non-Small Cell Lung Cancer

Non-small Cell Lung Cancer Clinical Trial

Official title:

A Randomized, Open-Label, Controlled, Multi-center Phase Ⅲ Study of Camrelizumab Combined With Famitinib Malate Versus Pembrolizumab in Treatment Naïve Subjects With PD-L1-Positive Recurrent or Metastatic Non-Small Cell Lung Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05042375
• Other study ID #: SHR-1210-III-331
• Status: Recruiting
• Phase: Phase 3
• Start date: September 8, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2022
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: weixia Li, M.M
• Phone: +86-15005136260
• Email: Weixia.li[@]hengrui.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is being conducted to evaluate the efficacy, and safety of camrelizumab combined with famitinib malate vs. pembrolizumab in treatment naïve subjects with programmed death-ligand 1(PD-L1)-positive recurrent or metastatic non-small cell lung cancer (NSCLC).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Have a histologically or cytologically confirmed diagnosis of metastatic NSCLC (stage IV according to the TNM staging criteria [8th edition] published by the International Association for the Study of Lung Cancer [IASLC]), or NSCLC that recurs after curable surgery, radiotherapy, or radiochemotherapy.

2. Have measurable disease based on RECIST v1.1.

3. ECOG PS score: 0-1.

4. Have a life expectancy of at least 3 months.

5. Non-surgically sterilized female subjects or women of childbearing potential must be negative for a serum pregnancy test within 3 days prior to the first dose and must be non-lactating. Female subjects of childbearing potential and male subjects with partners of childbearing potential must agree to take highly effective contraceptive measures during the study period and within 6 months after the last dose of study drugs.

6. Have voluntarily agreed to participate by giving written informed consent for the study, have good compliance, and cooperate with follow-up visits.

Exclusion Criteria:

1. Accompanied with EGFR activating mutation, ALK fusion gene positive or ROS1 mutation.

2. Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites.

3. Have known history of prior malignancy in the past 3 years.

4. Have had an allogeneic tissue/solid organ transplant.

5. Have active pulmonary tuberculosis.

6. Have clinical symptoms of the heart or heart diseases that are not well controlled.

7. Have hypertension which cannot be well controlled by antihypertensives

8. Urinalysis has indicated that the urine protein is = ++ and quantitative test of urine protein has confirmed that the 24-h urine protein is > 1.0 g.

9. Have a thrombosis tendency or are currently receiving thrombolysis/anticoagulation therapy.

10. Have received major surgery within 4 weeks prior to randomization; or palliative radiotherapy within 2 weeks prior to randomization; or have not recovered from the toxicities and/or complications of previous interventions to NCI-CTCAE Grade = 1.

11. Have known history of arterial/venous thrombosis within 6 months prior to randomization, such as cerebrovascular accidents, deep vein thrombosis and pulmonary embolism.

12. Have received prior therapy with anti-PD-1/PD-L1 monoclonal antibodies, anti-CTLA-4 monoclonal antibodies, or small molecule VEGFR inhibitors.

13. Have known allergies to other monoclonal antibodies or any component of famitinib.

14. Are currently participating and receiving study therapy or have participated in a study and received the last dose of study drug within 4 weeks (or 5 half-lives of the study drug) prior to randomization.

15. Have other potential factors that may affect the study results or result in the premature discontinuation as determined by the investigator, such as alcoholism, drug abuse, substance abuse, other serious diseases (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, or family or social factors that could affect the safety of medication.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Drug:
• camrelizumab + famitinib
Camrelizumab for injection, 200 mg; Famitinib malate capsules, 20 mg.
• pembrolizumab
pembrolizumab 200 mg.
• camrelizumab
Camrelizumab for injection, 200 mg.

Locations

Country	Name	City	State
China	Anyang Cancer Hospital	Anyang	Henan
China	Baoji Central Hospital	Baoji	Shanxi
China	Beijing Cancer Hospital	Beijing	Beijing
China	Beijing Chest Hospital,Capital Medical University	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	Army Medical Center of PLA	Changsha	Hunan
China	Hunan Cancer Hospital-Thoracic Medicine Department ?	Changsha	Hunan
China	Hunan Cancer Hospital-Thoracic Medicine Department I	Changsha	Hunan
China	Xiangya Hospital Central South University	Changsha	Hunan
China	Changzhi People's Hospital	Changzhi	Shanxi
China	Sichuan Cancer Hospital	Chengdu	Sichuan
China	Chifeng City Hospital	Chifeng	Neimenggu
China	ChongQing University Cancer Hospital	Chongqing	Chongqing
China	Fujian Medical University Union Hospital	Fuzhou	Fujian
China	Fujian Provincial Cancer Hospital	Fuzhou	Fujian
China	First Affiliated Hospital of Gannan Medical University	Ganzhou	Jiangxi
China	The People's Hospital of Gaozhou	Gaozhou	Guangdong
China	Affiliated Cancer Hospital and Institute of Guangzhou Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital of Guangzhou University of Chinese Medicine	Guangzhou	Guangdong
China	Affiliated Hospital of Guilin Medical University	Guilin	Guangxi
China	Haerbin Medical University Cancer Hospital	Ha'erbin	Heilongjiang
China	Hainan General Hospital	Haikou	Hainan
China	Hangzhou Cancer Hospital	Hangzhou	Zhejiang
China	The First Affiliated Hospital, College of Medicine, Zhejiang University of Medicine	Hangzhou	Zhejiang
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	ZheJiang Cancer Hospital	Hangzhou	Zhejiang
China	Anhui Chest Hospital	Hefei	Anhui
China	Anhui Provincial Cancer Hospital	Hefei	Anhui
China	Anhui Provincial Hospital	Hefei	Anhui
China	The First Affiliated Hospital Of Anhui Medical University	Hefei	Anhui
China	The Affiliated Hospital of Inner Mongolia Medical University	Hohhot	Neimenggu
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Shandong Cancer Hospital&Institute	Jinan	Shandong
China	Yunnan Cancer Hospital	Kunming	Yunnan
China	LinYi Cancer Hospital	Linyi	Shangdong
China	The First Affiliated Hosptial of Henan University of Science & Technology	Luoyang	Henan
China	The Affiliated Hospital of Southwest Medical University	Luzhou	Sichuan
China	Meizhou People's Hospital (Huangtang Hospital)	Meizhou	Guangdong
China	Mianyang Central Hospital	Mianyang	Sichuan
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Affiliated Drum Tower Hospital, Medical School of Nanjing University	Nanjing	Jiangsu
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu
China	Guangxi Medical University Affiliated Tumor Hospital	Nanning	Guangxi
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	Nantong Tumor Hospital	Nantong	Jiangsu
China	The Affiliated of Qingdao University	Qingdao	Shandong
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Shanghai Chest Hospital	Shanghai	Shanghai
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai
China	Shantou Central Hospital	Shantou	Guangdong
China	Shaoyang Central Hospital	Shaoyang	Hunan
China	Liaoning Cancer Hospital	Shenyang	Liaoning
China	Shengjing Hospital Affiliated to China Medical University	Shenyang	Liaoning
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	The Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Shiyan Taihe Hospital	Shiyan	Hubei
China	General Hospital of TISCO	Taiyuan	Shanxi
China	Shanxi Bethune Hospital	Taiyuan	Shanxi
China	Shanxi Provincial Cancer Hospital	Taiyuan	Shanxi
China	North China University Of Science And Technology Affiliated Hospital	Tangshan	Hebei
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin
China	Union Hospital Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei
China	Affiliated Hospital of JiangNan University	Wuxi	Jiangsu
China	The Second Affiliated Hospital of Air Force Military University Tangdu Hospital	Xi'an	Shanxi
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	The Second Affiliated Hospital of Xiamen Medical College	Xiamen	Fujian
China	Xiangyang Central Hospital	Xiangyang	Hubei
China	Xingtai People's Hospital	Xingtai	Hebei
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Northern Jiangsu People's Hospital	Yangzhou	Jiangsu
China	Yibin Second People's Hospital	Yibin	Sichuan
China	Affiliated Hospital of Guangdong Medical University	Zhanjiang	Guangdong
China	Henan Cancer Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Zhuzhou Central Hospital	Zhuzhou	Hunan
China	Affiliated Hospital of Zunyi Medical University	Zunyi	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS assessed by BIRC	Progression-Free-Survival, defined as the time from randomization to the first occurrence of disease progression as determined by IRC with use of RECIST v1.1 or death from any cause, whichever occurs first.	up to 3 years
Secondary	PFS assessed by investigator	Progression-Free-Survival	up to 3 years
Secondary	ORR	Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (CR or PR) across all assessment time points	up to 3 years
Secondary	DCR	Disease Control Rate, determined using RECIST v1.1 criteria	up to 3 years
Secondary	DoR	Duration of Response, determined using RECIST v1.1 criteria	up to 3 years
Secondary	TTF	Time to Treatment Failure, defined as the time from randomization to treatment discontinuation.	up to 3 years
Secondary	AEs+SAEs	Adverse Events and Serious Adverse Events	from the first drug administration to within 90 days for the last SHR-1210 dose
Secondary	OS	OS is the time interval from the date of randomization to death due to any reason or lost of follow-up	up to 4 years