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

November 16, 2022 updated by: Jiangsu HengRui Medicine Co., Ltd.

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233000
        • Not yet recruiting
        • The First Affiliated Hospital of Bengbu Medical College
        • Principal Investigator:
          • Chengling Zhao
      • Hefei, Anhui, China, 230000
        • Not yet recruiting
        • Anhui Chest Hospital
        • Principal Investigator:
          • Haowei Fang
      • Hefei, Anhui, China, 230000
        • Not yet recruiting
        • Anhui Provincial Hospital
        • Principal Investigator:
          • Xinghua Han
      • Hefei, Anhui, China, 230000
        • Not yet recruiting
        • Anhui Provincial Cancer Hospital
        • Principal Investigator:
          • Zhihong Zhang
      • Hefei, Anhui, China, 230000
        • Not yet recruiting
        • The First Affiliated Hospital of Anhui Medical University
        • Principal Investigator:
          • Yingying Du
    • Beijing
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Peking University Third Hospital
        • Principal Investigator:
          • Baoshan Cao
      • Beijing, Beijing, China, 100000
        • Not yet recruiting
        • Beijing Cancer Hospital
      • Beijing, Beijing, China, 100000
        • Not yet recruiting
        • Beijing Chest Hospital,Capital Medical University
        • Principal Investigator:
          • Tongmei Zhang
    • Chongqing
      • Chongqing, Chongqing, China, 400000
        • Recruiting
        • Chongqing University Cancer Hospital
        • Principal Investigator:
          • Luchun LI
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Not yet recruiting
        • Fujian Medical University Union Hospital
        • Principal Investigator:
          • Jinhuo Lai
      • Fuzhou, Fujian, China, 350000
        • Not yet recruiting
        • Fujian Provincial Cancer Hospital
        • Principal Investigator:
          • Zhiyong He
      • Xiamen, Fujian, China, 361000
        • Not yet recruiting
        • The First Affiliated Hospital of Xiamen University
        • Principal Investigator:
          • Qihong Zhuang
      • Xiamen, Fujian, China, 361000
        • Recruiting
        • The Second Affiliated Hospital of Xiamen Medical College
        • Principal Investigator:
          • Hui Yang
    • Guangdong
      • Gaozhou, Guangdong, China, 525200
        • Not yet recruiting
        • The People's Hospital of Gaozhou
        • Principal Investigator:
          • Wanli Lin
      • Guangzhou, Guangdong, China, 510000
        • Not yet recruiting
        • Affiliated Cancer Hospital and Institute of Guangzhou Medical University
        • Principal Investigator:
          • Jian Wang
      • Guangzhou, Guangdong, China, 510000
        • Not yet recruiting
        • The First Affiliated Hospital of Guangzhou Medical University
        • Principal Investigator:
          • Chengzhi Zhou
      • Guangzhou, Guangdong, China, 510000
        • Not yet recruiting
        • The First Affiliated Hospital of Guangzhou University of Chinese Medicine
        • Principal Investigator:
          • Lizhu Lin
      • Meizhou, Guangdong, China, 514000
        • Not yet recruiting
        • Meizhou People's Hospital (Huangtang Hospital)
        • Principal Investigator:
          • Guowu Wu
      • Shantou, Guangdong, China, 515000
        • Not yet recruiting
        • Shantou Central Hospital
        • Principal Investigator:
          • Xunyan Liu
      • Zhanjiang, Guangdong, China, 524000
        • Not yet recruiting
        • Affiliated Hospital of Guangdong Medical University
        • Principal Investigator:
          • Hualin Chen
    • Guangxi
      • Guilin, Guangxi, China, 541000
        • Not yet recruiting
        • Affiliated Hospital of Guilin Medical University
        • Principal Investigator:
          • Mafei Kang
      • Nanning, Guangxi, China, 530000
        • Not yet recruiting
        • Guangxi Medical University Affiliated Tumor Hospital
        • Principal Investigator:
          • Aiping Zeng
      • Nanning, Guangxi, China, 530000
        • Not yet recruiting
        • The First Affiliated Hospital of Guangxi Medical University
        • Principal Investigator:
          • Zhiyi He
    • Guizhou
      • Zunyi, Guizhou, China, 563000
        • Not yet recruiting
        • Affiliated Hospital of Zunyi Medical University
        • Principal Investigator:
          • Liang Zhou
    • Hainan
      • Haikou, Hainan, China, 570100
        • Not yet recruiting
        • Hainan General Hospital
        • Principal Investigator:
          • yongxing chen
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Not yet recruiting
        • The Fourth Hospital of Hebei Medical University
      • Tangshan, Hebei, China, 063000
        • Not yet recruiting
        • North China University of Science and Technology Affiliated Hospital
        • Principal Investigator:
          • Guogui Sun
      • Xingtai, Hebei, China, 054000
        • Not yet recruiting
        • Xingtai People's Hospital
        • Principal Investigator:
          • Yonghui Di
    • Heilongjiang
      • Ha'erbin, Heilongjiang, China, 150000
        • Not yet recruiting
        • Haerbin Medical University Cancer Hospital
    • Henan
      • Anyang, Henan, China, 455000
        • Recruiting
        • Anyang Cancer Hospital
        • Principal Investigator:
          • Yonggui Hong
      • Luoyang, Henan, China, 471000
        • Recruiting
        • The First Affiliated Hosptial of Henan University of Science & Technology
        • Principal Investigator:
          • Jun Yao
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Principal Investigator:
          • Guojun Zhang
      • Zhengzhou, Henan, China, 450000
        • Not yet recruiting
        • Henan Cancer Hospital
    • Hubei
      • Shiyan, Hubei, China, 442000
        • Not yet recruiting
        • Shiyan Taihe Hospital
        • Principal Investigator:
          • Meifang Wang
      • Wuhan, Hubei, China, 430000
        • Not yet recruiting
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
      • Xiangyang, Hubei, China, 441000
        • Recruiting
        • Xiangyang Central Hospital
    • Hunan
      • Changsha, Hunan, China, 410000
        • Not yet recruiting
        • Xiangya Hospital Central South University
        • Principal Investigator:
          • Huaping Yang
      • Changsha, Hunan, China, 410000
        • Recruiting
        • Army Medical Center of PLA
        • Principal Investigator:
          • Xuewen Liu
      • Changsha, Hunan, China, 410000
        • Recruiting
        • Hunan Cancer Hospital-Thoracic Medicine Department I
        • Principal Investigator:
          • Yongzhong Luo
      • Changsha, Hunan, China, 410000
        • Recruiting
        • Hunan Cancer Hospital-Thoracic Medicine Department Ⅱ
      • Shaoyang, Hunan, China, 422000
        • Recruiting
        • Shaoyang Central Hospital
        • Principal Investigator:
          • Xinfu Liu
      • Zhuzhou, Hunan, China, 412000
        • Not yet recruiting
        • ZhuZhou Central Hospital
        • Principal Investigator:
          • Bo Qiu
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Zhongda Hospital Southeast University
        • Principal Investigator:
          • Ruifeng Zhang
      • Nanjing, Jiangsu, China, 210000
        • Not yet recruiting
        • Affiliated Drum Tower Hospital, Medical School of Nanjing University
      • Nantong, Jiangsu, China, 226000
        • Not yet recruiting
        • Nantong Tumor Hospital
        • Principal Investigator:
          • Junguo Lu
      • Wuxi, Jiangsu, China, 214000
        • Recruiting
        • Affiliated Hospital of Jiangnan University
      • Xuzhou, Jiangsu, China, 221000
        • Not yet recruiting
        • The Affiliated Hospital Of XuZhou Medical University
        • Principal Investigator:
          • Bi Chen
      • Yangzhou, Jiangsu, China, 225000
        • Recruiting
        • Northern Jiangsu People's Hospital
        • Principal Investigator:
          • Xingxiang Xu
    • Jiangxi
      • Ganzhou, Jiangxi, China, 341000
        • Not yet recruiting
        • First Affiliated Hospital of Gannan Medical University
        • Principal Investigator:
          • Huaqiu Shi
      • Nanchang, Jiangxi, China, 330000
        • Recruiting
        • The First Affiliated Hospital Of Nanchang University
        • Principal Investigator:
          • Fei Xu
      • Nanchang, Jiangxi, China, 330000
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Principal Investigator:
          • Anwen Liu
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Not yet recruiting
        • The First Hospital of China Medical University
        • Principal Investigator:
          • Bo Jin
      • Shenyang, Liaoning, China, 110000
        • Not yet recruiting
        • Liaoning cancer hospital
        • Principal Investigator:
          • Jinghui Bai
      • Shenyang, Liaoning, China, 110000
        • Not yet recruiting
        • Shengjing Hospital affiliated to China Medical University
        • Principal Investigator:
          • Wei Zheng
    • Neimenggu
      • Chifeng, Neimenggu, China, 024000
        • Not yet recruiting
        • Chifeng City Hospital
        • Principal Investigator:
          • Minghui Zhang
      • Hohhot, Neimenggu, China, 010000
        • Not yet recruiting
        • The Affiliated Hospital of Inner Mongolia Medical University
        • Principal Investigator:
          • Qun Hu
    • Shandong
      • Jinan, Shandong, China, 250000
        • Not yet recruiting
        • Qilu Hospital Of Shandong University
        • Principal Investigator:
          • Yufeng Cheng
      • Jinan, Shandong, China, 250000
        • Not yet recruiting
        • Shandong Cancer Hospital&Institute
        • Principal Investigator:
          • Xiqin Zhang
      • Qingdao, Shandong, China, 266000
        • Not yet recruiting
        • The Affiliated of Qingdao University
        • Principal Investigator:
          • Jing Wang
    • Shangdong
      • Linyi, Shangdong, China, 276000
        • Not yet recruiting
        • LinYi Cancer Hospital
        • Principal Investigator:
          • Jianhua Shi
    • Shanghai
      • Shanghai, Shanghai, China, 200000
        • Recruiting
        • Shanghai Pulmonary Hospital
      • Shanghai, Shanghai, China, 200000
        • Not yet recruiting
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • Principal Investigator:
          • Min Zhou
      • Shanghai, Shanghai, China, 200000
        • Not yet recruiting
        • Fudan University Shanghai Cancer Center
        • Principal Investigator:
          • Si Sun
      • Shanghai, Shanghai, China, 200000
        • Not yet recruiting
        • Shanghai Chest Hospital
        • Principal Investigator:
          • Hua Zhong
    • Shanxi
      • Baoji, Shanxi, China, 721000
        • Not yet recruiting
        • Baoji Central Hospital
        • Principal Investigator:
          • Yaning Zhao
      • Changzhi, Shanxi, China, 046000
        • Not yet recruiting
        • Changzhi People's Hospital
        • Principal Investigator:
          • Jun Zhao
      • Taiyuan, Shanxi, China, 030000
        • Not yet recruiting
        • General Hospital of TISCO
        • Principal Investigator:
          • Weihua Jia
      • Taiyuan, Shanxi, China, 030000
        • Not yet recruiting
        • Shanxi Bethune Hospital
        • Principal Investigator:
          • Qi Mei
      • Taiyuan, Shanxi, China, 030000
        • Recruiting
        • Shanxi Provincial Cancer Hospital
        • Principal Investigator:
          • Weihua Yang
      • Xi'an, Shanxi, China, 710000
        • Recruiting
        • The Second Affiliated Hospital of Air Force Military University Tangdu Hospital
        • Principal Investigator:
          • Haichuan Su
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Not yet recruiting
        • Sichuan Cancer hospital
      • Luzhou, Sichuan, China, 646000
        • Not yet recruiting
        • The Affiliated Hospital of Southwest Medical University
        • Principal Investigator:
          • Peirong Ren
      • Mianyang, Sichuan, China, 621000
        • Not yet recruiting
        • Mianyang Central Hospital
        • Principal Investigator:
          • Weiguo Xu
      • Yibin, Sichuan, China, 644000
        • Not yet recruiting
        • Yibin Second People's Hospital
        • Principal Investigator:
          • Shanbing Wang
    • Tianjin
      • Tianjin, Tianjin, China, 300000
        • Recruiting
        • Tianjin Medical University Cancer Institute & Hospital
        • Principal Investigator:
          • Dingzhi Huang
    • Yunnan
      • Kunming, Yunnan, China, 650000
        • Not yet recruiting
        • Yunnan Cancer Hospital
        • Principal Investigator:
          • Yunchao Huang
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • Zhejiang Cancer Hospital
        • Principal Investigator:
          • Yun Fan
      • Hangzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • Hangzhou Cancer Hospital
        • Principal Investigator:
          • Xueqin Chen
      • Hangzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • The First Affiliated Hospital, College of Medicine, Zhejiang University of Medicine
        • Principal Investigator:
          • Jianya Zhou
      • Hangzhou, Zhejiang, China, 310000
        • Not yet recruiting
        • The second affiliated hospital of zhejiang university school of medicine
        • Principal Investigator:
          • Wen Li

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: camrelizumab + famitinib
Drug: camrelizumab + famitinib
Camrelizumab for injection, 200 mg; Famitinib malate capsules, 20 mg.
Experimental: pembrolizumab
Drug: pembrolizumab
pembrolizumab 200 mg.
Experimental: camrelizumab
Drug: camrelizumab
Camrelizumab for injection, 200 mg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS assessed by BIRC
Time Frame: 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.
up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS assessed by investigator
Time Frame: up to 3 years
Progression-Free-Survival
up to 3 years
ORR
Time Frame: 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
up to 3 years
DCR
Time Frame: up to 3 years
Disease Control Rate, determined using RECIST v1.1 criteria
up to 3 years
DoR
Time Frame: up to 3 years
Duration of Response, determined using RECIST v1.1 criteria
up to 3 years
TTF
Time Frame: up to 3 years
Time to Treatment Failure, defined as the time from randomization to treatment discontinuation.
up to 3 years
AEs+SAEs
Time Frame: from the first drug administration to within 90 days for the last SHR-1210 dose
Adverse Events and Serious Adverse Events
from the first drug administration to within 90 days for the last SHR-1210 dose
OS
Time Frame: 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
up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

September 1, 2021

First Submitted That Met QC Criteria

September 9, 2021

First Posted (Actual)

September 13, 2021

Study Record Updates

Last Update Posted (Actual)

November 17, 2022

Last Update Submitted That Met QC Criteria

November 16, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-1210-III-331

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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