A Trial of Camrelizumab Combined With Famitinib Malate in Treatment Naïve Subjects With PD-L1-Positive Recurrent or Metastatic Non-Small Cell Lung Cancer
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
1 other identifier
interventional
450
1 country
80
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 nonsmall-cell-lung-cancer
Started Sep 2022
80 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2021
CompletedFirst Posted
Study publicly available on registry
September 13, 2021
CompletedStudy Start
First participant enrolled
September 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedNovember 17, 2022
October 1, 2022
1.3 years
September 1, 2021
November 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
PFS assessed by investigator
up to 3 years
ORR
up to 3 years
DCR
up to 3 years
DoR
up to 3 years
TTF
up to 3 years
- +2 more secondary outcomes
Study Arms (3)
camrelizumab + famitinib
EXPERIMENTALpembrolizumab
EXPERIMENTALcamrelizumab
EXPERIMENTALInterventions
Camrelizumab for injection, 200 mg; Famitinib malate capsules, 20 mg.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (80)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233000, China
Anhui Chest Hospital
Hefei, Anhui, 230000, China
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230000, China
Anhui Provincial Hospital
Hefei, Anhui, 230000, China
The First Affiliated Hospital Of Anhui Medical University
Hefei, Anhui, 230000, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100000, China
Beijing Chest Hospital,Capital Medical University
Beijing, Beijing Municipality, 100000, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100000, China
ChongQing University Cancer Hospital
Chongqing, Chongqing Municipality, 400000, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000, China
Fujian Provincial Cancer Hospital
Fuzhou, Fujian, 350000, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, 361000, China
The Second Affiliated Hospital of Xiamen Medical College
Xiamen, Fujian, 361000, China
The People's Hospital of Gaozhou
Gaozhou, Guangdong, 525200, China
Affiliated Cancer Hospital and Institute of Guangzhou Medical University
Guangzhou, Guangdong, 510000, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510000, China
Meizhou People's Hospital (Huangtang Hospital)
Meizhou, Guangdong, 514000, China
Shantou Central Hospital
Shantou, Guangdong, 515000, China
Affiliated Hospital of Guangdong Medical University
Zhanjiang, Guangdong, 524000, China
Affiliated Hospital of Guilin Medical University
Guilin, Guangxi, 541000, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, 530000, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530000, China
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000, China
Hainan General Hospital
Haikou, Hainan, 570100, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
North China University Of Science And Technology Affiliated Hospital
Tangshan, Hebei, 063000, China
Xingtai People's Hospital
Xingtai, Hebei, 054000, China
Haerbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
Anyang Cancer Hospital
Anyang, Henan, 455000, China
The First Affiliated Hosptial of Henan University of Science & Technology
Luoyang, Henan, 471000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000, China
Shiyan Taihe Hospital
Shiyan, Hubei, 442000, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
Xiangyang Central Hospital
Xiangyang, Hubei, 441000, China
Army Medical Center of PLA
Changsha, Hunan, 410000, China
Hunan Cancer Hospital-Thoracic Medicine Department I
Changsha, Hunan, 410000, China
Hunan Cancer Hospital-Thoracic Medicine Department Ⅱ
Changsha, Hunan, 410000, China
Xiangya Hospital Central South University
Changsha, Hunan, 410000, China
Shaoyang Central Hospital
Shaoyang, Hunan, 422000, China
Zhuzhou Central Hospital
Zhuzhou, Hunan, 412000, China
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, 210000, China
Zhongda Hospital Southeast University
Nanjing, Jiangsu, 210000, China
Nantong Tumor Hospital
Nantong, Jiangsu, 226000, China
Affiliated Hospital of JiangNan University
Wuxi, Jiangsu, 214000, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000, China
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu, 225000, China
First Affiliated Hospital of Gannan Medical University
Ganzhou, Jiangxi, 341000, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000, China
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000, China
Liaoning Cancer Hospital
Shenyang, Liaoning, 110000, China
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, 110000, China
The First Hospital of China Medical University
Shenyang, Liaoning, 110000, China
Chifeng City Hospital
Chifeng, Neimenggu, 024000, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Neimenggu, 010000, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250000, China
Shandong Cancer Hospital&Institute
Jinan, Shandong, 250000, China
The Affiliated of Qingdao University
Qingdao, Shandong, 266000, China
LinYi Cancer Hospital
Linyi, Shangdong, 276000, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200000, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000, China
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200000, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200000, China
Baoji Central Hospital
Baoji, Shanxi, 721000, China
Changzhi People's Hospital
Changzhi, Shanxi, 046000, China
General Hospital of TISCO
Taiyuan, Shanxi, 030000, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 030000, China
Shanxi Provincial Cancer Hospital
Taiyuan, Shanxi, 030000, China
The Second Affiliated Hospital of Air Force Military University Tangdu Hospital
Xi’an, Shanxi, 710000, China
Sichuan Cancer Hospital
Chengdu, Sichuan, 610000, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000, China
Mianyang Central Hospital
Mianyang, Sichuan, 621000, China
Yibin Second People's Hospital
Yibin, Sichuan, 644000, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300000, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650000, China
Hangzhou Cancer Hospital
Hangzhou, Zhejiang, 310000, China
The First Affiliated Hospital, College of Medicine, Zhejiang University of Medicine
Hangzhou, Zhejiang, 310000, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
ZheJiang Cancer Hospital
Hangzhou, Zhejiang, 310000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 1, 2021
First Posted
September 13, 2021
Study Start
September 8, 2022
Primary Completion
December 31, 2023
Study Completion
December 31, 2025
Last Updated
November 17, 2022
Record last verified: 2022-10