A Trial of Camrelizumab Combined With Famitinib Malate in Treatment Naïve Subjects With PD-L1-Positive Recurrent or Metastatic Non-Small Cell Lung Cancer
- Conditions
- Non-small Cell Lung Cancer
- Interventions
- Registration Number
- NCT05042375
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 450
- 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.
- Have measurable disease based on RECIST v1.1.
- ECOG PS score: 0-1.
- Have a life expectancy of at least 3 months.
- 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.
- Have voluntarily agreed to participate by giving written informed consent for the study, have good compliance, and cooperate with follow-up visits.
- Accompanied with EGFR activating mutation, ALK fusion gene positive or ROS1 mutation.
- Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, or ascites.
- Have known history of prior malignancy in the past 3 years.
- Have had an allogeneic tissue/solid organ transplant.
- Have active pulmonary tuberculosis.
- Have clinical symptoms of the heart or heart diseases that are not well controlled.
- Have hypertension which cannot be well controlled by antihypertensives
- 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.
- Have a thrombosis tendency or are currently receiving thrombolysis/anticoagulation therapy.
- 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.
- Have known history of arterial/venous thrombosis within 6 months prior to randomization, such as cerebrovascular accidents, deep vein thrombosis and pulmonary embolism.
- Have received prior therapy with anti-PD-1/PD-L1 monoclonal antibodies, anti-CTLA-4 monoclonal antibodies, or small molecule VEGFR inhibitors.
- Have known allergies to other monoclonal antibodies or any component of famitinib.
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description pembrolizumab pembrolizumab - camrelizumab + famitinib camrelizumab + famitinib - camrelizumab camrelizumab -
- Primary Outcome Measures
Name Time Method PFS assessed by BIRC up to 3 years 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.
- Secondary Outcome Measures
Name Time Method DCR up to 3 years Disease Control Rate, determined using RECIST v1.1 criteria
DoR up to 3 years Duration of Response, determined using RECIST v1.1 criteria
TTF up to 3 years Time to Treatment Failure, defined as the time from randomization to treatment discontinuation.
AEs+SAEs from the first drug administration to within 90 days for the last SHR-1210 dose Adverse Events and Serious Adverse Events
ORR up to 3 years Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (CR or PR) across all assessment time points
OS up to 4 years OS is the time interval from the date of randomization to death due to any reason or lost of follow-up
PFS assessed by investigator up to 3 years Progression-Free-Survival
Trial Locations
- Locations (80)
Shaoyang Central Hospital
🇨🇳Shaoyang, Hunan, China
Xiangyang Central Hospital
🇨🇳Xiangyang, Hubei, China
Hunan Cancer Hospital-Thoracic Medicine Department I
🇨🇳Changsha, Hunan, China
Haerbin Medical University Cancer Hospital
🇨🇳Ha'erbin, Heilongjiang, China
Army Medical Center of PLA
🇨🇳Changsha, Hunan, China
Anyang Cancer Hospital
🇨🇳Anyang, Henan, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
The First Affiliated Hosptial of Henan University of Science & Technology
🇨🇳Luoyang, Henan, China
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Shiyan Taihe Hospital
🇨🇳Shiyan, Hubei, China
Affiliated Hospital of JiangNan University
🇨🇳Wuxi, Jiangsu, China
Northern Jiangsu People's Hospital
🇨🇳Yangzhou, Jiangsu, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Shengjing Hospital Affiliated to China Medical University
🇨🇳Shenyang, Liaoning, China
General Hospital of TISCO
🇨🇳Taiyuan, Shanxi, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital Of Anhui Medical University
🇨🇳Hefei, Anhui, China
The People's Hospital of Gaozhou
🇨🇳Gaozhou, Guangdong, China
Affiliated Hospital of Guangdong Medical University
🇨🇳Zhanjiang, Guangdong, China
North China University Of Science And Technology Affiliated Hospital
🇨🇳Tangshan, Hebei, China
Xingtai People's Hospital
🇨🇳Xingtai, Hebei, China
Hunan Cancer Hospital-Thoracic Medicine Department Ⅱ
🇨🇳Changsha, Hunan, China
Xiangya Hospital Central South University
🇨🇳Changsha, Hunan, China
Zhuzhou Central Hospital
🇨🇳Zhuzhou, Hunan, China
Affiliated Drum Tower Hospital, Medical School of Nanjing University
🇨🇳Nanjing, Jiangsu, China
First Affiliated Hospital of Gannan Medical University
🇨🇳Ganzhou, Jiangxi, China
Zhongda Hospital Southeast University
🇨🇳Nanjing, Jiangsu, China
The Second Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Liaoning Cancer Hospital
🇨🇳Shenyang, Liaoning, China
The First Hospital of China Medical University
🇨🇳Shenyang, Liaoning, China
Shandong Cancer Hospital&Institute
🇨🇳Jinan, Shandong, China
The Affiliated of Qingdao University
🇨🇳Qingdao, Shandong, China
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China
Shanxi Bethune Hospital
🇨🇳Taiyuan, Shanxi, China
Shanxi Provincial Cancer Hospital
🇨🇳Taiyuan, Shanxi, China
The Second Affiliated Hospital of Air Force Military University Tangdu Hospital
🇨🇳Xi'an, Shanxi, China
Tianjin Medical University Cancer Institute & Hospital
🇨🇳Tianjin, Tianjin, China
ZheJiang Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
Anhui Chest Hospital
🇨🇳Hefei, Anhui, China
Anhui Provincial Cancer Hospital
🇨🇳Hefei, Anhui, China
Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
Beijing Cancer Hospital
🇨🇳Beijing, Beijing, China
Beijing Chest Hospital,Capital Medical University
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China
ChongQing University Cancer Hospital
🇨🇳Chongqing, Chongqing, China
Fujian Medical University Union Hospital
🇨🇳Fuzhou, Fujian, China
Fujian Provincial Cancer Hospital
🇨🇳Fuzhou, Fujian, China
The First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, Fujian, China
The Second Affiliated Hospital of Xiamen Medical College
🇨🇳Xiamen, Fujian, 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
Meizhou People's Hospital (Huangtang Hospital)
🇨🇳Meizhou, Guangdong, China
Shantou Central Hospital
🇨🇳Shantou, Guangdong, China
Affiliated Hospital of Guilin Medical University
🇨🇳Guilin, Guangxi, China
Guangxi Medical University Affiliated Tumor Hospital
🇨🇳Nanning, Guangxi, China
The First Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
Affiliated Hospital of Zunyi Medical University
🇨🇳Zunyi, Guizhou, China
Hainan General Hospital
🇨🇳Haikou, Hainan, China
The Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Nantong Tumor Hospital
🇨🇳Nantong, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
🇨🇳Xuzhou, Jiangsu, China
The Affiliated Hospital of Inner Mongolia Medical University
🇨🇳Hohhot, Neimenggu, China
Chifeng City Hospital
🇨🇳Chifeng, Neimenggu, China
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China
LinYi Cancer Hospital
🇨🇳Linyi, Shangdong, 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
Baoji Central Hospital
🇨🇳Baoji, Shanxi, China
Changzhi People's Hospital
🇨🇳Changzhi, Shanxi, China
Sichuan Cancer Hospital
🇨🇳Chengdu, Sichuan, China
The Affiliated Hospital of Southwest Medical University
🇨🇳Luzhou, Sichuan, China
Mianyang Central Hospital
🇨🇳Mianyang, Sichuan, China
Yibin Second People's Hospital
🇨🇳Yibin, Sichuan, China
Yunnan Cancer Hospital
🇨🇳Kunming, Yunnan, China
Hangzhou Cancer Hospital
🇨🇳Hangzhou, Zhejiang, China
The First Affiliated Hospital, College of Medicine, Zhejiang University of Medicine
🇨🇳Hangzhou, Zhejiang, China