Lung Adenocarcinoma
Conditions
Interventions
experimental group:Camrelizumab, Pemetrexed, Carboplatin /Cisplatin
Sponsors
Beijing Chao-Yang Hospital Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years to 70 years. 2. Subjects who are chemotherapy naive and have Stage IIIB-IV non-squamous NSCLC. 3. Subjects should not have a previously detected sensitizing EGFR mutation or ALK fusion oncogene. 4. 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 12 months from randomization since the last chemotherapy cycle. 5. Have a life expectancy of at least 3 months. 6. Eastern Cooperative Oncology Group (ECOG) performance status of = 90 g/L b Absolute neutrophil count >= 2 * 10^9/L c Platelets >= 100 * 10^9/L d Total bilirubin (TBIL) 50 mL/minute (using Cockcroft/Gault formula). 9. Female Subjects of childbearing potential must have a negative serum pregnancy test within 3 days before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 180 days after the last dose of study treatment. 10. Male Subjects with a female partner(s) of child-bearing potential must be willing to use very efficient barrier methods of contraception for the course of the study through 180 days after the last dose of study treatment. 11. Subjects has voluntarily agreed to participate by giving written informed consent/assent for the trial.
Exclusion criteria
Exclusion criteria: 1. Patients with brain metastasis or meningeal metastasis. 2. Subjects used immunosuppressive drugs excluding nasal spray and inhaled corticosteroids or systemic steroids at physiological doses (prednisolone 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. 4. Accompanied by uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage. 5. 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). 6. Subjects with childhood asthma has completely resolved, adults can be included without any intervention; subjects with bronchodilators for medical intervention can not be included . 7. 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 anticoagulationNote: under the premise that the international standardized ratio of prothrombin time (INR) is = ++, or confirms that 24-hour urine protein is >= 1.0 g. 9. Patients with non-healing wound, non-healing ulcer, or non-healing bone fracture; 10. 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 degree C. 11. 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. 12. Patients with a clear history of allergies may be potentially allergic to or intolerant to biological agents such as carboplatin, cisplatin, pemetrexed, and camrelizumab; 13. There are obvious factors affecting oral drug absorption, such as inability to swallow, chronic diarrhea and intestinal obstruction. Or sinus or perforation of empty organs within 6 months. 14. Any known mental illness or substance abuse that may have an impact on compliance with the test requirements. 15. There are other factors lead to patients can not participate in this clinical study by the judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS;1 year progression free survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| ORR;DCR;OS;DOR;AE; | — |
Countries
China
Contacts
Public ContactAn Guangyu
Beijing Chao-Yang Hospital Affiliated to Capital Medical University
Outcome results
None listed