Combining camrelizumab and famitinib for treating advanced 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

This study is testing a new combination of two drugs, camrelizumab and famitinib, to see if it helps people with advanced lung cancer feel better compared to a standard treatment.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 450 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (industry)
• Drugs / interventions: famitinib, camrelizumab, pembrolizumab
• Locations: 80 sites (Bengbu, Anhui and 79 other locations)
• Trial ID: NCT05042375 on ClinicalTrials.gov

What this trial studies

This trial evaluates the effectiveness and safety of a combination treatment using camrelizumab and famitinib malate compared to pembrolizumab in patients with PD-L1-positive recurrent or metastatic non-small cell lung cancer (NSCLC) who have not received prior treatment. The study aims to determine how well this combination works in managing the disease and its associated symptoms. Participants will be closely monitored for their response to the treatment and any potential side effects.

Who should consider this trial

Good fit: Ideal candidates are individuals with confirmed metastatic NSCLC who have not yet received treatment and have a PD-L1-positive status.

Not a fit: Patients with early-stage lung cancer or those who have already undergone treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients with advanced lung cancer.

How similar studies have performed: Other studies have shown promising results with similar immunotherapy approaches, indicating potential for success in this trial.

Eligibility criteria

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.

Where this trial is running

Bengbu, Anhui and 79 other locations

• The First Affiliated Hospital of Bengbu Medical College — Bengbu, Anhui, China (NOT_YET_RECRUITING)
• Anhui Chest Hospital — Hefei, Anhui, China (NOT_YET_RECRUITING)
• Anhui Provincial Cancer Hospital — Hefei, Anhui, China (NOT_YET_RECRUITING)
• Anhui Provincial Hospital — Hefei, Anhui, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital Of Anhui Medical University — Hefei, Anhui, China (NOT_YET_RECRUITING)
• Beijing Cancer Hospital — Beijing, Beijing, China (NOT_YET_RECRUITING)
• Beijing Chest Hospital,Capital Medical University — Beijing, Beijing, China (NOT_YET_RECRUITING)
• Peking University Third Hospital — Beijing, Beijing, China (RECRUITING)
• ChongQing University Cancer Hospital — Chongqing, Chongqing, China (RECRUITING)
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (NOT_YET_RECRUITING)
• Fujian Provincial Cancer Hospital — Fuzhou, Fujian, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China (NOT_YET_RECRUITING)
• The Second Affiliated Hospital of Xiamen Medical College — Xiamen, Fujian, China (RECRUITING)
• The People's Hospital of Gaozhou — Gaozhou, Guangdong, China (NOT_YET_RECRUITING)
• Affiliated Cancer Hospital and Institute of Guangzhou Medical University — Guangzhou, Guangdong, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Guangzhou University of Chinese Medicine — Guangzhou, Guangdong, China (NOT_YET_RECRUITING)
• Meizhou People's Hospital (Huangtang Hospital) — Meizhou, Guangdong, China (NOT_YET_RECRUITING)
• Shantou Central Hospital — Shantou, Guangdong, China (NOT_YET_RECRUITING)
• Affiliated Hospital of Guangdong Medical University — Zhanjiang, Guangdong, China (NOT_YET_RECRUITING)
• Affiliated Hospital of Guilin Medical University — Guilin, Guangxi, China (NOT_YET_RECRUITING)
• Guangxi Medical University Affiliated Tumor Hospital — Nanning, Guangxi, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (NOT_YET_RECRUITING)
• Affiliated Hospital of Zunyi Medical University — Zunyi, Guizhou, China (NOT_YET_RECRUITING)
• Hainan General Hospital — Haikou, Hainan, China (NOT_YET_RECRUITING)
• The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (NOT_YET_RECRUITING)
• North China University Of Science And Technology Affiliated Hospital — Tangshan, Hebei, China (NOT_YET_RECRUITING)
• Xingtai People's Hospital — Xingtai, Hebei, China (NOT_YET_RECRUITING)
• Haerbin Medical University Cancer Hospital — Ha'erbin, Heilongjiang, China (NOT_YET_RECRUITING)
• Anyang Cancer Hospital — Anyang, Henan, China (RECRUITING)
• The First Affiliated Hosptial of Henan University of Science & Technology — Luoyang, Henan, China (RECRUITING)
• Henan Cancer Hospital — Zhengzhou, Henan, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (RECRUITING)
• Shiyan Taihe Hospital — Shiyan, Hubei, China (NOT_YET_RECRUITING)
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, Hubei, China (NOT_YET_RECRUITING)
• Xiangyang Central Hospital — Xiangyang, Hubei, China (RECRUITING)
• Army Medical Center of PLA — Changsha, Hunan, China (RECRUITING)
• Hunan Cancer Hospital-Thoracic Medicine Department I — Changsha, Hunan, China (RECRUITING)
• Hunan Cancer Hospital-Thoracic Medicine Department Ⅱ — Changsha, Hunan, China (RECRUITING)
• Xiangya Hospital Central South University — Changsha, Hunan, China (NOT_YET_RECRUITING)
• Shaoyang Central Hospital — Shaoyang, Hunan, China (RECRUITING)
• Zhuzhou Central Hospital — Zhuzhou, Hunan, China (NOT_YET_RECRUITING)
• Affiliated Drum Tower Hospital, Medical School of Nanjing University — Nanjing, Jiangsu, China (NOT_YET_RECRUITING)
• Zhongda Hospital Southeast University — Nanjing, Jiangsu, China (RECRUITING)
• Nantong Tumor Hospital — Nantong, Jiangsu, China (NOT_YET_RECRUITING)
• Affiliated Hospital of JiangNan University — Wuxi, Jiangsu, China (RECRUITING)
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (NOT_YET_RECRUITING)
• Northern Jiangsu People's Hospital — Yangzhou, Jiangsu, China (RECRUITING)
• First Affiliated Hospital of Gannan Medical University — Ganzhou, Jiangxi, China (NOT_YET_RECRUITING)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (RECRUITING)

Study contacts

• Study coordinator: weixia Li, M.M

Conditions: Non-small Cell Lung Cancer