NSCLC
Conditions
Interventions
Prevention Group:Camrelizumab (200mg, D1, Q3W)+ thalidomide (100mg, QD)+ chemotherapy(Q3W,4~6 cycles)
Treatment Group:First occurrence of grade 2-3 RCCEP, camrelizumab-based regimen (200mg, D1, Q3W) plus thalidomide (100mg, QD)
Sponsors
The Affiliated Hospital of Xuzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. The age of the subjects was 18-75 years old (including 18 and 75 years old), regardness of gender. 2. Histopathologically or cytologically confirmed stage IV non-small-cell lung cancer (according to the Union for International Cancer Control/American Joint Committee on Cancer staging system, eighth edition). 3. Have at least one measurable lesion according to RECIST 1.1 criteria. No previous systemic therapy was required in the prevention cohort; Participants who had received curative neoadjuvant/adjuvant chemotherapy, radiotherapy, or concurrent chemoradiotherapy for nonmetastatic disease for at least 12 months from the last course of chemotherapy, radical surgery, radiotherapy, or the last course of concurrent chemoradiotherapy before enrollment. Grade 2-3 RCCEP first occurred when camrelizumone-based therapy was required in the treatment cohort. 6. Physical status score (ECOG PS) : 0-1. 7. Expected survival time = 6 months. 8. Negative for EGFR or ALK mutations 9. No active brain metastases. 10. The main organ function was good, that is, the relevant examination indicators within 14 days before enrollment met the following requirements: hemoglobin = 90 g/L (no blood transfusion within 14 days); Neutrophil count > 1.5×109/L; Platelet count = 100×109/L; Total bilirubin = 1.5×ULN (upper limit of normal); Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 2.5×ULN; If there was liver metastasis, ALT or AST = 5×ULN; Endogenous creatinine clearance = 60 mL/min (Cockcroft-Gault formula); Cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) = 50%. 11 Women of childbearing age must have a serum pregnancy study with a negative result within 7 days before the first dose. Female subjects of childbearing age and male subjects whose partner was a woman of childbearing age had to agree to use a highly effective method of contraception for the duration of the study and for 180 days after the last administration of the study drug. 12. Understand the study procedures and content, and voluntarily provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects diagnosed with other histopathological types of NSCLC, including squamous-glandular mixed carcinoma and NSCLC with small cell lung cancer components. 2. Known EGFR mutation or ALK-positive subjects. 3. Subjects previously treated with PD-(L)1, CTLA-4. 4. Antiangiogenic agents and gemcitabine were not allowed. Subjects with camrelizumab-induced RCCEP = grade 1 were excluded from the treatment cohort. 6. No RCCEP-targeting therapy other than thalidomide was allowed in the treatment cohort. 7. Subjects with active central nervous system (CNS) metastases. Participants were eligible if their CNS metastases could be managed adequately, if they had been clinically stable (as measured by MRI) for at least 4 weeks and if they had recovered to baseline levels of neurologic and other clinical symptoms (other than residual signs or symptoms related to CNS therapy) for at least 2 weeks before the first dose of medication. In addition, participants could not be enrolled if they were taking a stable or tapering dose of prednisone (or its equivalent) of 10 mg per day or less for at least 2 weeks to treat clinical symptoms associated with the use of corticosteroids. 8 subjects with active, known, or suspected autoimmune disease. Subjects with type I diabetes who were receiving stable doses of insulin, subjects with hypothyroidism who required only hormone replacement therapy, and skin conditions that did not require systemic therapy and had not acutely worsened in the year before the screening period (e.g., eczema, vitiligo, or bovine) 9. Have innate or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection; 10. Have the following poorly controlled infectious diseases: active viral hepatitis B (HBsAg positive and HBV DNA=500IU/ml or 1000copies/ml) or viral hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower limit of detection of the assay); Active TB or currently receiving anti-TB treatment; 11. Previous or present objective evidence of idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, tissue pneumonia (e.g., bronchitis, obliterative vasculitis), drug-induced pneumonia, active pneumonia on CT examination, or severe impairment of lung function; 12. Cardiac function and disease that was considered by the investigator to be clinically significant and significantly abnormal and not eligible for inclusion in the study, including but not limited to complete left bundle branch conduction abnormality, degree II atrioventricular block; QTc interval measured by 12-lead electrocardiogram (ECG) was =450ms in men and =470ms in women. New York Heart Association (NYHA) grade =3 cardiac dysfunction or echocardiography: left ventricular ejection fraction (LVEF) grade 2) occurred within 4 weeks before enrollment, such as infectious complications requiring treatment, bacteremia, severe pneumonia, etc. Subjects who have signs and symptoms of infection requiring treatment with oral or intravenous antibiotics (excluding prophylactic antibiotics) within 2 weeks before the first use of the drug and who require systemic antibiotics due to infection; 14. Diagnosis of immunodeficiency or receipt of systemic glucocorticoids or any other form of immunosuppressive therapy not directly related to oncologic therapy within 7 days before study entry; Physiologic doses of glucocortico
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of RCCEP of any grade;Recovery rate of RCCEP; | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS;OS;ORR;DCR;Median time to incidence of RCCEP;Safety;Median time to disappearance of RCCEP;Recovery rate of RCCEP at 3 weeks;Recovery rate of RCCEP at 6 weeks; | — |
Countries
China
Contacts
Public ContactZhengxiang Han
The Affiliated Hospital of Xuzhou Medical University
Outcome results
None listed