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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Drug: camrelizumab + famitinib
* Drug: pembrolizumab
* Drug: camrelizumab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Camrelizumab Combined with Famitinib Malate versus Pembrolizumab
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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