Status:
UNKNOWN
A Study of Sintilimab Compared With Docetaxel or Pemetrexed as Second-line Treatment for Patients With Stage IV Nonsquamous Non-small Cell Lung Cancer After Failure With Platinum-Containing Chemotherapy
Lead Sponsor:
Xin-Hua Xu
Conditions:
Nonsquamous Non-Small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This prospective, single-center, randomized, controlled study will evaluate the efficacy and safety of sintilimab compared with docetaxel or pemetrexed as second-line treatment for patients with stage...
Eligibility Criteria
Inclusion
- Volunteer to participate in clinical research; fully understand and know the research and sign informed consent;
- Age ≥ 18 years old and ≤ 75 years old, either sex;
- Eastern Collaborative Oncology Group Performance status (ECOG PS) 0, 1 or 2;
- Has a histologically or cytologically confirmed diagnosis of stage IV (according to the 8th edition of the International Association for the Study of Lung Cancer) nonsquamous NSCLC;
- Have at least one measurable lesion as defined by RECIST 1.1;
- Has progression of disease after treatment with at least two cycles of a platinum-containing doublet chemotherapy according to RECIST V.1.1;
- Patients without activating EGFR mutation;
- Normal hepatic function: total bilirubin≤1.5×normal upper limit (ULN); Alanine aminotransferase and Aspartate aminotransferase levels ≤2.5×ULN or ≤5×ULN if liver metastasis is present;
- Normal renal function: Creatinine ≤1.5×ULN or calculated creatinine clearance ≥45 mL/min (using Cockcroft/Gault formula to calculate );
- Normal hematological function: absolute neutrophil count ≥1.5×109/L, platelet count ≥70×109/L, hemoglobin≥80g/L \[no blood transfusion or erythropoietin (EPO) within 7 days\] Dependency\];
- Has a life expectancy of at ≥3 months.
Exclusion
- ECOG PS \>2;
- Small cell lung cancer and squamous NSCLC;
- EGFR mutation or mutation status unknown;
- Known hypersensitivity or allergy to monoclonal antibody;
- Prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2, anti-tumor necrosis factor CD137, or anti-cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody (including any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways);
- Active autoimmune disease, or a documented history of autoimmune disease;
- Treatment with systemic corticosteroids (prednisone≥10mg per day or equivalent dose) or other systemic immunosuppressive medications within 2 weeks prior to the first dose;
- Known history or active human immunodeficiency virus (HIV);
- Known acute or chronic active hepatitis B (HBV DNA positive) infection or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive) infection;
- Interstitial lung disease, or history of pneumonitis requiring systemic steroids for treatment;
- Active or poorly controlled severe infection;
- Have serious cardiovascular disease: Symptomatic congestive heart failure (New York Heart Association grade III-IV), unstable angina pectoris, unstable arrhythmia, myocardial infarction or cerebrovascular accident within 3 months before randomization;
- Received thoracic radiation therapy of \>30 Gy within 6 months prior to first dose of study drug;
- Completed palliative radiotherapy within 7 days prior to first dose of study drug;
- Pregnant or lactating women.
Key Trial Info
Start Date :
March 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2022
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT03830411
Start Date
March 13 2019
End Date
June 30 2022
Last Update
November 8 2021
Active Locations (1)
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1
Department of Medical Oncology, Central Hospital of Yichang City, the First Clinical Medical College of Three Gorges University
Yichang, Hubei, China, 443003