Status:
UNKNOWN
Camrelizumab Combined With Endostar for First-line Treatment in Subjects With Advanced Squamous NSCLC
Lead Sponsor:
Peking University Cancer Hospital & Institute
Collaborating Sponsors:
Peking University First Hospital
Peking University Third Hospital
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study is a single-arm, prospective, multi-center clinical trial. designed to evaluate patients with stage IV inability to receive or refuse chemotherapy.Efficacy and safety of first-line treatmen...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Subjects \>/= 18 years of age at the time of Informed Consent.
- Subjects with histopathological diagnosis of squamous non-small cell lung cancer (SqNSCLC) have a histologically or cytologically confirmed stage IV (American Joint Committee on Cancer \[AJCC\] 8th edition) , and the stage IIIB/IIIC SqNSCLC that is unresectable and not fit for radical concurrent chemoradiotherapy.
- .No prior systemic treatment. Subjects who have received prior neo-adjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment free interval of at least 6 months from randomization since the last chemotherapy cycle.
- Life expectancy of at least three months.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Subjects enrolled must have measurable lesion(s) according to the RECIST 1.1 standard (the CT scan length of the tumor lesion \> 10 mm, the short diameter of CT scan of the lymph node lesions \> 15 mm).
- The main organ function is normal. All baseline laboratory requirements will be assessed and should be obtained within -14 days of randomization. Screening laboratory values must meet the following criteria.
- Hemoglobin ≥ 9.0 g/dL (90 g/L)
- Absolute neutrophil count ≥ 2× 109/L
- Platelets ≥ 100× 109/L
- Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal(ULN); alkaline phosphatase ≤ 5 × ULN
- Serum creatinine ≤ 1× ULN or creatinine clearance \> 60 mL/minute (using Cockcroft/Gault formula)
- Subject dosen't have unhealed wounds before enrollment.
- Female participants of childbearing potential must have a negative serum pregnancy test within -7 days of randomization and must be willing to use very efficient barrier methods of contraception or a barrier method plus a hormonal method starting with the screening visit through 60 days (about 5 drug half-life + menstrual cycle) after the last dose of SHR-1210. Male participants with a female partner(s) of child-bearing potential must be willing to use very efficient barriermethods of contraception from screening through 120 days (about 5 drug half-life + sperm depletion cycle) after the last dose of SHR-1210.
- Subjects should be voluntarily participate in clinical studies and informed consent should be signed.
- Exclusion Criteria
- Active central nervous system (CNS) metastasis and/or cancerous meningitis. Patients with treated brain metastases who were clinically stable for at least 2 weeks and have no new or advanced brain metastases may be enrolled. Patients with known untreated, asymptomatic brain metastases can be enrolled provided cerebral imaging assessment be regularly performed.
- Subjects used immunosuppressive drugs excluding nasal spray and inhaled corticosteroids or systemic steroids at physiological doses(prednisolone≤10 mg/day or other corticosteroids of the same pharmacophysiological dose) within 14 days before the first dose.
- Subjects with grade II or above myocardial ischemia or myocardial infarction and poorly controlled arrhythmias (QTc interval \> 450 ms for males and QTc interval \> 470 ms for females). Subjects with grade III-IV cardiac insufficiency or with left ventricular ejection fraction (LVEF) less than 50% had myocardial infarction within 6 months before admission according to NYHA criteria. Subjects with uncontrolled hypertension.
- Participants who had any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis , Hyperthyroidism, decreased thyroid function).
- subjects with childhood asthma has completely resolved, adults can be included without any intervention; subjects with bronchodilators for medical intervention can not be included .
- Participants who had abnormal blood coagulation (INR\>1.5 or PT\> ULN+4s, and or APTT \> 1.5 ULN), bleeding tendency or receiving thrombolytic or anticoagulation；
- Urine routine indicates urinary protein ≥ ++, or confirms that 24-hour urine protein is ≥1.0 g；
- Patients with non-healing wound, non-healing ulcer, or non-healing bone fracture;
- The patient has severe infection within 4 weeks before first administration（such as the need for intravenous antibiotics, antifungals or antivirals) and unexplained fever within 7 days before administration, ≥38.5 °C
- There was significant coughing blood and significant clinically significant bleeding symptoms or a clear tendency to hemorrhage in the first 2 months before enrollment (such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood ++ and above at baseline, or suffering from vasculitis, etc.).
- Serious Arterial / venous thrombosis events, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, within 12 months before enrollment.
- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating acute or chronic infection. (HBV: HBsAg positive and HBV DNA ≥ 500 IU/mL ; HVC: HCV RNA positive and abnormal liver function). And subjects with active tuberculosis.
- History of severe hypersensitivity reactions to any component contained in Endostar or antibody preparation of Camrelizumab. And known to have severe allergic reactions to infusion reactions.
- Any known mental illness or substance abuse that may have an impact on compliance with the test requirements;
- There are other factors lead to patients can not participate in this clinical study by the judgment of the investigator.
Exclusion
Key Trial Info
Start Date :
December 31 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT04303130
Start Date
December 31 2019
End Date
December 31 2022
Last Update
March 10 2020
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142