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

Last updated: November 16, 2022
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Overall Status: Active - Recruiting

Phase

3

Condition

Non-small Cell Lung Cancer

Treatment

N/A

Clinical Study ID

NCT05042375
SHR-1210-III-331
  • Ages 18-75
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Have a histologically or cytologically confirmed diagnosis of metastatic NSCLC (stageIV according to the TNM staging criteria [8th edition] published by the InternationalAssociation for the Study of Lung Cancer [IASLC]), or NSCLC that recurs after curablesurgery, 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 benegative for a serum pregnancy test within 3 days prior to the first dose and must benon-lactating. Female subjects of childbearing potential and male subjects withpartners of childbearing potential must agree to take highly effective contraceptivemeasures during the study period and within 6 months after the last dose of studydrugs.
  6. Have voluntarily agreed to participate by giving written informed consent for thestudy, have good compliance, and cooperate with follow-up visits.

Exclusion

Exclusion Criteria:

  1. Accompanied with EGFR activating mutation, ALK fusion gene positive or ROS1 mutation.
  2. Have uncontrolled clinically symptomatic pleural effusion, pericardial effusion, orascites.
  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 urineprotein has confirmed that the 24-h urine protein is > 1.0 g.
  9. Have a thrombosis tendency or are currently receiving thrombolysis/anticoagulationtherapy.
  10. Have received major surgery within 4 weeks prior to randomization; or palliativeradiotherapy within 2 weeks prior to randomization; or have not recovered from thetoxicities and/or complications of previous interventions to NCI-CTCAE Grade ≤ 1.
  11. Have known history of arterial/venous thrombosis within 6 months prior torandomization, such as cerebrovascular accidents, deep vein thrombosis and pulmonaryembolism.
  12. Have received prior therapy with anti-PD-1/PD-L1 monoclonal antibodies, anti-CTLA-4monoclonal 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 astudy and received the last dose of study drug within 4 weeks (or 5 half-lives of thestudy drug) prior to randomization.
  15. Have other potential factors that may affect the study results or result in thepremature discontinuation as determined by the investigator, such as alcoholism, drugabuse, substance abuse, other serious diseases (including mental illness) requiringconcomitant treatment, serious laboratory abnormalities, or family or social factorsthat could affect the safety of medication.

Study Design

Total Participants: 450
Study Start date:
September 08, 2022
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui 233000
    China

    Site Not Available

  • Anhui Chest Hospital

    Hefei, Anhui 230000
    China

    Site Not Available

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui 230000
    China

    Site Not Available

  • Anhui Provincial Hospital

    Hefei, Anhui 230000
    China

    Site Not Available

  • The First Affiliated Hospital Of Anhui Medical University

    Hefei, Anhui 230000
    China

    Site Not Available

  • Beijing Cancer Hospital

    Beijing, Beijing 100000
    China

    Site Not Available

  • Beijing Chest Hospital,Capital Medical University

    Beijing, Beijing 100000
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, Beijing 100000
    China

    Active - Recruiting

  • ChongQing University Cancer Hospital

    Chongqing, Chongqing 400000
    China

    Active - Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian 350000
    China

    Site Not Available

  • Fujian Provincial Cancer Hospital

    Fuzhou, Fujian 350000
    China

    Site Not Available

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian 361000
    China

    Site Not Available

  • The Second Affiliated Hospital of Xiamen Medical College

    Xiamen, Fujian 361000
    China

    Active - Recruiting

  • The People's Hospital of Gaozhou

    Gaozhou, Guangdong 525200
    China

    Site Not Available

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • Meizhou People's Hospital (Huangtang Hospital)

    Meizhou, Guangdong 514000
    China

    Site Not Available

  • Shantou Central Hospital

    Shantou, Guangdong 515000
    China

    Site Not Available

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong 524000
    China

    Site Not Available

  • Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi 541000
    China

    Site Not Available

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, Guangxi 530000
    China

    Site Not Available

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi 530000
    China

    Site Not Available

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou 563000
    China

    Site Not Available

  • Hainan General Hospital

    Haikou, Hainan 570100
    China

    Site Not Available

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei 050000
    China

    Site Not Available

  • North China University Of Science And Technology Affiliated Hospital

    Tangshan, Hebei 063000
    China

    Site Not Available

  • Xingtai People's Hospital

    Xingtai, Hebei 054000
    China

    Site Not Available

  • Haerbin Medical University Cancer Hospital

    Ha'erbin, Heilongjiang 150000
    China

    Site Not Available

  • Anyang Cancer Hospital

    Anyang, Henan 455000
    China

    Active - Recruiting

  • The First Affiliated Hosptial of Henan University of Science & Technology

    Luoyang, Henan 471000
    China

    Active - Recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan 450000
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450000
    China

    Active - Recruiting

  • Shiyan Taihe Hospital

    Shiyan, Hubei 442000
    China

    Site Not Available

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei 430000
    China

    Site Not Available

  • Xiangyang Central Hospital

    Xiangyang, Hubei 441000
    China

    Active - Recruiting

  • Army Medical Center of PLA

    Changsha, Hunan 410000
    China

    Active - Recruiting

  • Hunan Cancer Hospital-Thoracic Medicine Department I

    Changsha, Hunan 410000
    China

    Active - Recruiting

  • Hunan Cancer Hospital-Thoracic Medicine Department Ⅱ

    Changsha, Hunan 410000
    China

    Active - Recruiting

  • Xiangya Hospital Central South University

    Changsha, Hunan 410000
    China

    Site Not Available

  • Shaoyang Central Hospital

    Shaoyang, Hunan 422000
    China

    Active - Recruiting

  • Zhuzhou Central Hospital

    Zhuzhou, Hunan 412000
    China

    Site Not Available

  • Affiliated Drum Tower Hospital, Medical School of Nanjing University

    Nanjing, Jiangsu 210000
    China

    Site Not Available

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu 210000
    China

    Active - Recruiting

  • Nantong Tumor Hospital

    Nantong, Jiangsu 226000
    China

    Site Not Available

  • Affiliated Hospital of JiangNan University

    Wuxi, Jiangsu 214000
    China

    Active - Recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu 221000
    China

    Site Not Available

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu 225000
    China

    Active - Recruiting

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi 341000
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330000
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330000
    China

    Active - Recruiting

  • Liaoning Cancer Hospital

    Shenyang, Liaoning 110000
    China

    Site Not Available

  • Shengjing Hospital Affiliated to China Medical University

    Shenyang, Liaoning 110000
    China

    Site Not Available

  • The First Hospital of China Medical University

    Shenyang, Liaoning 110000
    China

    Site Not Available

  • Chifeng City Hospital

    Chifeng, Neimenggu 024000
    China

    Site Not Available

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Neimenggu 010000
    China

    Site Not Available

  • Qilu Hospital of Shandong University

    Jinan, Shandong 250000
    China

    Site Not Available

  • Shandong Cancer Hospital&Institute

    Jinan, Shandong 250000
    China

    Site Not Available

  • The Affiliated of Qingdao University

    Qingdao, Shandong 266000
    China

    Site Not Available

  • LinYi Cancer Hospital

    Linyi, Shangdong 276000
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai 200000
    China

    Site Not Available

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai 200000
    China

    Site Not Available

  • Shanghai Chest Hospital

    Shanghai, Shanghai 200000
    China

    Site Not Available

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai 200000
    China

    Active - Recruiting

  • Baoji Central Hospital

    Baoji, Shanxi 721000
    China

    Site Not Available

  • Changzhi People's Hospital

    Changzhi, Shanxi 046000
    China

    Site Not Available

  • General Hospital of TISCO

    Taiyuan, Shanxi 030000
    China

    Site Not Available

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi 030000
    China

    Site Not Available

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi 030000
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Air Force Military University Tangdu Hospital

    Xi'an, Shanxi 710000
    China

    Active - Recruiting

  • Sichuan Cancer Hospital

    Chengdu, Sichuan 610000
    China

    Site Not Available

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan 646000
    China

    Site Not Available

  • Mianyang Central Hospital

    Mianyang, Sichuan 621000
    China

    Site Not Available

  • Yibin Second People's Hospital

    Yibin, Sichuan 644000
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin 300000
    China

    Active - Recruiting

  • Yunnan Cancer Hospital

    Kunming, Yunnan 650000
    China

    Site Not Available

  • Hangzhou Cancer Hospital

    Hangzhou, Zhejiang 310000
    China

    Site Not Available

  • The First Affiliated Hospital, College of Medicine, Zhejiang University of Medicine

    Hangzhou, Zhejiang 310000
    China

    Site Not Available

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310000
    China

    Site Not Available

  • ZheJiang Cancer Hospital

    Hangzhou, Zhejiang 310000
    China

    Site Not Available

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