small cell lung cancer
Conditions
Interventions
Experimental group:Benmelstobart 1200mg, IV, Q3W
Sponsors
Anhui Provincial Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old; 2. Histologically or cytologically confirmed limited-stage small cell lung cancer; 3. No progression after chemoradiotherapy; 4. ECOG PS score: 0-1; 5. Good organ and bone function, defined as follows: Absolute neutrophil count >=1.5×10^9/L,Platelet count >=100×10^9/L, Hemoglobin >= 9g/dL((no blood transfusion was allowed within 7 days before screening) laboratory examinations should conform to the following criteria, serum bilirubin 60 ml/min for patients receiving cisplatin and > 45 ml/min for patients receiving carboplatin(Calculated according to Cockcroft-Gault formula); 6. The subjects voluntarily joined the study, signed the informed consent form, and the compliance was good.
Exclusion criteria
Exclusion criteria: 1. Previously received systemic anti-tumor treatment for limited-stage small cell lung cancer(such as chemotherapy, biotherapy, targeted therapy, immunotherapy, or experimental drug treatment, etc.); 2.Patients with other malignancies or a history of other malignancies within the last 5 years, except for well-controlled tumors, such as skin basal cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ; 3. Patients with any severe or uncontrolled systemic disease, including uncontrolled hypertension, diabetes, and active bleeding. Subjects who are deemed unable to comply with the study requirements or complete the study. Any factor, in the opinion of the investigator, unfavorable for the patient to participate in the study or undermines compliance with the protocol. 4. Patients with serious illnesses, such as active or uncontrolled infections (tuberculosis, HIV, etc.), decompensated liver disease, active hepatitis, active bleeding; patients with cerebrovascular accident events or pulmonary embolism; active, known or suspected autoimmune diseases; 5. Patients with any significant abnormalities in clinical and laboratory examinations would interfere evaluation of the safety such as (1)ventricular arrhythmia, supraventricular arrhythmia, nodal arrhythmia or atrial fibrillation with rapid ventricular rate requiring clinical intervention, and patients with QTc interval (QTcB) > 480ms; (2) patients with grade III or above congestive heart failure (NCI-CTC AE v5.0), uncontrolled or unstable angina pectoris or myocardial infarction within 6 months before screening; (3) extensive interstitial lung disease in need of treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression free survival, PFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival, OS;objective response rate, ORR;Drug safety and tolerability; | — |
Countries
China
Contacts
Public ContactXu Ke
Anhui Provincial Cancer Hospital
Outcome results
None listed