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Non-small Cell Lung CancerPhase 3NCT05042375

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 Phase 3 study testing camrelizumab + famitinib, pembrolizumab and camrelizumab in people with Non-small Cell Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 80 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
camrelizumab + famitinib, pembrolizumab and camrelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
450 participants
Where
80 sitesChina
Study dates
8 Sep 2022to 31 Dec 2025
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 15Show fewer
  • 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.

Trial locations and contacts

80 sites in 1 country.

weixia Li, M.M contact

+86-15005136260

Weixia.li@hengrui.com

80 sites in 1 country

China80 sites, 80 recruiting

  • Anyang Cancer Hospital

    Anyang, Henan, 455000

    Yonggui Hong

    Recruiting

  • Baoji Central Hospital

    Baoji, Shanxi, 721000

    Yaning Zhao

    Not yet recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100000

    Jian Fang

    Not yet recruiting

  • Beijing Chest Hospital,Capital Medical University

    Beijing, Beijing Municipality, 100000

    Tongmei Zhang

    Not yet recruiting

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100000

    Baoshan Cao

    Recruiting

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233000

    Chengling Zhao

    Not yet recruiting

  • Army Medical Center of PLA

    Changsha, Hunan, 410000

    Xuewen Liu

    Recruiting

  • Hunan Cancer Hospital-Thoracic Medicine Department I

    Changsha, Hunan, 410000

    Yongzhong Luo

    Recruiting

  • Hunan Cancer Hospital-Thoracic Medicine Department Ⅱ

    Changsha, Hunan, 410000

    Lin Wu

    Recruiting

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410000

    Huaping Yang

    Not yet recruiting

  • Changzhi People's Hospital

    Changzhi, Shanxi, 046000

    Jun Zhao

    Not yet recruiting

  • Sichuan Cancer Hospital

    Chengdu, Sichuan, 610000

    Wenxiu Yao

    Not yet recruiting

  • Chifeng City Hospital

    Chifeng, Neimenggu, 024000

    Minghui Zhang

    Not yet recruiting

  • ChongQing University Cancer Hospital

    Chongqing, Chongqing Municipality, 400000

    Luchun LI

    Recruiting

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350000

    Jinhuo Lai

    Not yet recruiting

  • Fujian Provincial Cancer Hospital

    Fuzhou, Fujian, 350000

    Zhiyong He

    Not yet recruiting

  • First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi, 341000

    Huaqiu Shi

    Not yet recruiting

  • The People's Hospital of Gaozhou

    Gaozhou, Guangdong, 525200

    Wanli Lin

    Not yet recruiting

  • Affiliated Cancer Hospital and Institute of Guangzhou Medical University

    Guangzhou, Guangdong, 510000

    Jian Wang

    Not yet recruiting

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510000

    Chengzhi Zhou

    Not yet recruiting

  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine

    Guangzhou, Guangdong, 510000

    Lizhu Lin

    Not yet recruiting

  • Affiliated Hospital of Guilin Medical University

    Guilin, Guangxi, 541000

    Mafei Kang

    Not yet recruiting

  • Hainan General Hospital

    Haikou, Hainan, 570100

    Yongxing Chen

    Not yet recruiting

  • Hangzhou Cancer Hospital

    Hangzhou, Zhejiang, 310000

    Xueqin Chen

    Not yet recruiting

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

    Hangzhou, Zhejiang, 310000

    Jianya Zhou

    Not yet recruiting

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310000

    Wen Li

    Not yet recruiting

  • ZheJiang Cancer Hospital

    Hangzhou, Zhejiang, 310000

    Yun Fan

    Not yet recruiting

  • Haerbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

    Yan Wang

    Not yet recruiting

  • Anhui Chest Hospital

    Hefei, Anhui, 230000

    Haowei Fang

    Not yet recruiting

  • Anhui Provincial Cancer Hospital

    Hefei, Anhui, 230000

    Zhihong Zhang

    Not yet recruiting

  • Anhui Provincial Hospital

    Hefei, Anhui, 230000

    Xinghua Han

    Not yet recruiting

  • The First Affiliated Hospital Of Anhui Medical University

    Hefei, Anhui, 230000

    Yingying Du

    Not yet recruiting

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Neimenggu, 010000

    Qun Hu

    Not yet recruiting

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 250000

    Yufeng Cheng

    Not yet recruiting

  • Shandong Cancer Hospital&Institute

    Jinan, Shandong, 250000

    Xiqin Zhang

    Not yet recruiting

  • Yunnan Cancer Hospital

    Kunming, Yunnan, 650000

    Yunchao Huang

    Not yet recruiting

  • LinYi Cancer Hospital

    Linyi, Shangdong, 276000

    Jianhua Shi

    Not yet recruiting

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

    Luoyang, Henan, 471000

    Jun Yao

    Recruiting

  • The Affiliated Hospital of Southwest Medical University

    Luzhou, Sichuan, 646000

    Peirong Ren

    Not yet recruiting

  • Meizhou People's Hospital (Huangtang Hospital)

    Meizhou, Guangdong, 514000

    Guowu Wu

    Not yet recruiting

  • Mianyang Central Hospital

    Mianyang, Sichuan, 621000

    Weiguo Xu

    Not yet recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

    Fei Xu

    Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330000

    Anwen Liu

    Recruiting

  • Affiliated Drum Tower Hospital, Medical School of Nanjing University

    Nanjing, Jiangsu, 210000

    Yongsheng Wang

    Not yet recruiting

  • Zhongda Hospital Southeast University

    Nanjing, Jiangsu, 210000

    Ruifeng Zhang

    Recruiting

  • Guangxi Medical University Affiliated Tumor Hospital

    Nanning, Guangxi, 530000

    Aiping Zeng

    Not yet recruiting

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530000

    Zhiyi He

    Not yet recruiting

  • Nantong Tumor Hospital

    Nantong, Jiangsu, 226000

    Junguo Lu

    Not yet recruiting

  • The Affiliated of Qingdao University

    Qingdao, Shandong, 266000

    Jing Wang

    Not yet recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000

    Si Sun

    Not yet recruiting

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200000

    Min Zhou

    Not yet recruiting

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200000

    Hua Zhong

    Not yet recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200000

    Caicun Zhou

    Recruiting

  • Shantou Central Hospital

    Shantou, Guangdong, 515000

    Xunyan Liu

    Not yet recruiting

  • Shaoyang Central Hospital

    Shaoyang, Hunan, 422000

    Xinfu Liu

    Recruiting

  • Liaoning Cancer Hospital

    Shenyang, Liaoning, 110000

    Jinghui Bai

    Not yet recruiting

  • Shengjing Hospital Affiliated to China Medical University

    Shenyang, Liaoning, 110000

    Wei Zheng

    Not yet recruiting

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110000

    Bo Jin

    Not yet recruiting

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

    Jun Wang

    Not yet recruiting

  • Shiyan Taihe Hospital

    Shiyan, Hubei, 442000

    Meifang Wang

    Not yet recruiting

  • General Hospital of TISCO

    Taiyuan, Shanxi, 030000

    Weihua Jia

    Not yet recruiting

  • Shanxi Bethune Hospital

    Taiyuan, Shanxi, 030000

    Qi Mei

    Not yet recruiting

  • Shanxi Provincial Cancer Hospital

    Taiyuan, Shanxi, 030000

    Weihua Yang

    Recruiting

  • North China University Of Science And Technology Affiliated Hospital

    Tangshan, Hebei, 063000

    Guogui Sun

    Not yet recruiting

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300000

    Dingzhi Huang

    Recruiting

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

    Wuhan, Hubei, 430000

    Xiaorong Dong

    Not yet recruiting

  • Affiliated Hospital of JiangNan University

    Wuxi, Jiangsu, 214000

    Xiaoping Chen

    Recruiting

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

    Xi’an, Shanxi, 710000

    Haichuan Su

    Recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361000

    Qihong Zhuang

    Not yet recruiting

  • The Second Affiliated Hospital of Xiamen Medical College

    Xiamen, Fujian, 361000

    Hui Yang

    Recruiting

  • Xiangyang Central Hospital

    Xiangyang, Hubei, 441000

    Tienan Yi

    Recruiting

  • Xingtai People's Hospital

    Xingtai, Hebei, 054000

    Yonghui Di

    Not yet recruiting

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, 221000

    Bi Chen

    Not yet recruiting

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu, 225000

    Xingxiang Xu

    Recruiting

  • Yibin Second People's Hospital

    Yibin, Sichuan, 644000

    Shanbing Wang

    Not yet recruiting

  • Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong, 524000

    Hualin Chen

    Not yet recruiting

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

    Qiming Wang

    Not yet recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

    Guojun Zhang

    Recruiting

  • Zhuzhou Central Hospital

    Zhuzhou, Hunan, 412000

    Bo Qiu

    Not yet recruiting

  • Affiliated Hospital of Zunyi Medical University

    Zunyi, Guizhou, 563000

    Liang Zhou

    Not yet recruiting

Other trials in China

About this study

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

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).

Being tested
camrelizumab + famitinib, pembrolizumab, camrelizumab
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • camrelizumab + famitinibDrug

    Camrelizumab for injection, 200 mg; Famitinib malate capsules, 20 mg.

  • pembrolizumabDrug

    pembrolizumab 200 mg.

  • camrelizumabDrug

    Camrelizumab for injection, 200 mg.

Study groups in NCT05042375
Study groupRoleWhat they receive
camrelizumab + famitinibExperimentalNot described
Receives: Drug: camrelizumab + famitinib
pembrolizumabExperimentalNot described
Receives: Drug: pembrolizumab
camrelizumabExperimentalNot described
Receives: Drug: camrelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: up to 3 years

Secondary outcomes (7)

  1. PFS assessed by investigator

    Progression-Free-Survival

    Measured: up to 3 years

  2. ORR

    Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (CR or PR) across all assessment time points

    Measured: up to 3 years

  3. DCR

    Disease Control Rate, determined using RECIST v1.1 criteria

    Measured: up to 3 years

  4. DoR

    Duration of Response, determined using RECIST v1.1 criteria

    Measured: up to 3 years

  5. TTF

    Time to Treatment Failure, defined as the time from randomization to treatment discontinuation.

    Measured: up to 3 years

  6. AEs+SAEs

    Adverse Events and Serious Adverse Events

    Measured: from the first drug administration to within 90 days for the last SHR-1210 dose

  7. OS

    OS is the time interval from the date of randomization to death due to any reason or lost of follow-up

    Measured: up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2021
  2. Study start8 Sep 2022
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Camrelizumab Combined with Famitinib Malate versus Pembrolizumab
Masking
None (open label)
Enrolment
450 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05042375
Sponsor's protocol ID
SHR-1210-III-331
Status last verified
Oct 2022
First submitted
1 Sep 2021
Last updated
17 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing camrelizumab + famitinib, pembrolizumab and camrelizumab in people with Non-small Cell Lung Cancer, run by Jiangsu HengRui Medicine Co., Ltd. at 80 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact weixia Li, M.M (+86-15005136260, Weixia.li@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS assessed by BIRC (time frame: up to 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05042375.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.

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