Lung cancer
Conditions
Interventions
single arm treatment group:PD-1 antibody, 200mg, intravenously, per 3 weeks
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Has a histologically or cytologically confirmed diagnosis of pulmonary sarcomatoid carcinoma; 3. Has received no more than two prior chemotherapy regimens 4. Has measurable disease based on RECIST 1.1 as determined by the local site investigator/radiology assessment; 5. Has a performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Status; 6. Has a life expectancy of at least 3 months. 7. Has adequate organ function. Neutrophil >= 1.5 x 10^9/L, platlete >= 80 x 10^9/L, Hb >= 90g/L; TBIL <= 1.5*ULN, AST <= 2.5*ULN, ALT <= 2.5*ULN, INR <= 1.5*ULN; 8. If female of childbearing potential, is willing to use an adequate method of contraception for the course of the study through 120 days after the last dose of study drug; 9. If male with a female partner(s) of child-bearing potential, must agree to use an adequate method of contraception starting with the first dose of study drug through 120 days after the last dose of study drug. Males with pregnant partners must agree to use a condom; no additional method of contraception is required for the pregnant partner; 10. Patients volunteere to participate in current study. Have signed informed consent and have good compliance.
Exclusion criteria
Exclusion criteria: 1. Patients who are currently participating in interventional clinical study treatment or who have received other study drugs or study devices within 4 weeks before the first administration. 2. Had prior treatment with any other anti-programmed cell death 1 (anti-PD-1), or programmed cell death ligand 1 (PD-L1) or PD-L2 agent or an antibody or a small molecule targeting other immuno-regulatory receptors or mechanisms (CTLA4, OX-40, CD137 etc). 3. Had received anti-cancer Chinese herbs or other immune regulatory drugs within last 2 weeks, or received surgery within last 3 weeks. 4. Have obvious hemoptysis, intraperitoneal abscess, gastrointestinal obstruction, peritoneal metastasis. 5. Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. 6. Has a history of organ transplantation. 7. With uncontrolled arrhythmia, congestive heart failure with stage III-IV. 8. Had artery thrombosis within last 3 months or venous thrombosis within last 3 months. 9. Previously had a severe hypersensitivity reaction to PD-1 inhibitor or other monoclonal antibody. 10. Has active autoimmune disease that has required systemic treatment in past 2 years. 11. Has a disease that need long time systemic use of steroids. Those patients using inhaled steroids for asthma or COPD is eligible. 12. Has pre-existing peripheral neuropathy that is >= Grade 2 by Common Terminology Criteria for Adverse Events (CTCAE) version 4 criteria. 13. Has a known history of prior malignancy except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy (except resected carcinoma in situ). 14. Has active non-infectious pneumonitis before the first treatment 15. Had active inflammation which need antibiotics within 1 week. 16. Patients with known mental illness or substance abuse conditions that may affect compliance with the trial. 17. Has known history of Human Immunodeficiency Virus (HIV), Active TB, syphilis infection. 18. Has known active Hepatitis B. It is eligible if patients with HBSAg positive have HBV copy number less than 200IU/ml. 19. Has known active hepatitis C. 20. Has received a live-virus vaccination within 30 days of planned treatment start. 21.has a history of disease or medications that may interfere with the results of the trial or prevent the patiens from fully participating in the study, or the investigator believes that participation in the study is not in the subject's best interest; 22. Had a disease that might interrupt evaluation for the drug, 23.investigator think he/she is not suitable for the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival;1 year PFS rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| overall response rate;overall survival;safety;quanlity of life; | — |
Countries
China
Contacts
Public ContactFengying Wu
Shanghai Pulmonary Hospital
Outcome results
None listed