Non-small cell lung cancer
Conditions
Interventions
cohort 1:Camrelizumab 200mg d1, Q3W, up to 2 years+Platinum-based chemotherapy, d1, Q3W, 2 cycles
cohort 2:Camrelizumab 200mg d1, Q3W, up to 2 years+Platinum-based chemotherapy, d1, Q3W, 4 cycles
Sponsors
General Hospital of Eastern Theater command
Eligibility
Sex/Gender
All
Age
18 Years to 200 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged >= 18 years; 2. Understand the research procedure and content, and voluntarily sign written informed consent; 3. Histologically or cytologically confirmed stage IIIB-IV non-small cell lung cancer; 4. At least one measurable lesion (as assessed by the investigators based on RECIST V1.1); 5. No systematic treatment in the past; 6. Physical condition score (ECOG PS score) : 0-1; 7. Estimated survival time >= 3 months; 8. No EGFR/ALK gene mutation positive, EGFR/ALK gene mutation status unknown is not mandatory testing; 9. Subjects without active brain metastases are allowed to be included; 10. The function of major organs was good, that is, the relevant examination indicators met the following requirements within 14 days before enrollment: hemoglobin >= 90 g/L (no blood transfusion within 14 days); Neutrophil count & GT; 1.5 x 10^9 / L; Platelet count >= 100*10^9/L; Total bilirubin = 60 mL/min (Cockcroft-Gault formula); Left ventricular ejection fraction (LVEF) >= 50%;
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of other malignancies, except for carcinoma in situ that has achieved a complete response at least 5 years before screening and that does not require or is expected to require additional treatment during the study period; 2. Subjects with known or suspected interstitial pneumonia; Other moderate-to-severe pulmonary diseases that may interfere with the detection or management of drug-related pulmonary toxicity and that seriously affect respiratory function. These include, for example, idiopathic pulmonary fibrosis, organizing pneumonia/bronchiolitis obliterans, etc. 3. Subjects with serious cardiovascular and cerebrovascular diseases, Such as NYHA standard (level III or higher), within 3 months before or for the first time to give medicine or cerebrovascular accident happened in myocardial infarction, cerebral ischemia, symptomatic cerebral infarction, etc.), or associated with coronary artery disease, and within a month before the first delivery of the instability of arrhythmia or unstable angina, or congestive heart failure, or outside of the above standard screening period Left ventricular ejection fraction & LT; 50%, or the superior vena cava syndrome with existing symptoms; 4. Female subjects who are pregnant, lactating, or planning to become pregnant during the study; 5. History of live attenuated vaccine inoculation within 28 days before the first study medication or expected to receive live attenuated vaccine inoculation during the study; 6. Subjects with active hepatitis B (defined as a positive HBsAg test result and HBV-DNA test value >= 2000 IU/ML during the screening period) or hepatitis C (defined as a positive HBV-surface antibody [HCsAb] test result and HVC-RNA positive during the screening period); 7. Severe infection occurred within 4 weeks before the first dose, including but not limited to infection complications requiring hospitalization or >= 2 weeks of intravenous antibiotic treatment, bacteremia, severe pneumonia, etc.; 8. There were clinically significant bleeding symptoms or obvious bleeding tendency within 1 month before screening, such as gastrointestinal bleeding, gastric ulcer bleeding or vasculitis; 9. Uncontrolled moderate to large amounts of pleural, abdominal, or pericardial effusion requiring repeated drainage; 10. History of severe allergic reaction to other monoclonal antibodies; Allergic or intolerant to infusion; History of severe allergy to pemetrexed, taxa, carboplatin or its prophylaxis. 11. The subject is known to have a history of psychotropic substance abuse, alcoholism or drug abuse; 12. The researchers believe any other medicine (such as lung, metabolic, hormonal, or nervous system disease and congenital diseases, etc.), psychosis, or social status may interfere with the subjects of rights, safety, health or ability to sign the informed consent, cooperation and participation in the study, or interfere with the study drug evaluation, read the safety or the results of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 6-month progression-free survival (PFS) rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| progression-free survival ;objective response rate; | — |
Countries
China
Contacts
Public ContactHongbing Liu
General Hospital of Eastern Theater Command
Outcome results
None listed