A Study of LK101 Combined With PD-1 or PD-L1 Monoclonal Antibody in the Treatment of Lung Cancer to Evaluate the Safety, Tolerability and Preliminary Efficacy
This is a open lable, single-center phase Ib/IIa study for patients with local advanced or metastastic NSCLC or ES-SCLC, who failed with previous anti-PD-1/PD-L1 therapy (cohort 1 and cohort 2) and for patients with ocal advanced or metastastic NSCLC received the first line treatment (cohort 3). The aim is to observe and evaluate the safety, tolerability and efficacy of LK101 injection combined with pembrolizumab, durvalumab or tislelizumab respectively in the incurable NSCLC and SCLC.
• signed informed consent;
• ≥18years, male or female;
• cohort1: Histologically/cytologically confirmed locally advanced or metastastic Non-small lung carcinoma (NSCLC), and received systemic treatment for recurrence/metastasis ≤3 lines; cohort2: Histologically/cytologically confirmed extensive small-cell lung carcinoma (ES-SCLC); Cohort 1 and Cohort 2 required patients progressed/recurrenced after anti-PD-1/PD-L1treatment;
• Cohort 3: Histologically/cytologically confirmed locally advanced or metastatic non-small cell lung cancer (NSCLC) with no driver gene mutation and have PD-L1 expression, and who have not experienced disease progression after receiving chemotherapy combined with an anti-PD-1 therapy.
• Life expectancy of more than 3 months;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1;
• At least one measurable lesion according to RECIST 1.1;
• The sequencing of tumor were qualified;
• According to the invistigators' judgment, venous vascular conditions can meet the needs of apheresis;
• For adequate organ function, the patients need to meet the following laboratory indexes:
‣ hematologic functions(No blood transfusion or treatment with blood components and without granulocyte colony stimulating factor in the past 14 days.):
• the absolute value of neutrophils (ANC) ≥ 1.5x109/L;
∙ the platelet count was ≥ 90x109/L;
∙ the hemoglobin \> 9g/dL;
⁃ Hepatic functions:
• Total bilirubin ≤ 1.5 × normal upper limit (ULN); patients with liver metastasis allow ≤ 3 × ULN;
∙ aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN (patients with liver metastasis allow ALT or AST ≤ 5 × ULN);
⁃ renal
• Serum creatinine ≤ 1.5 × ULN and creatinine clearance (calculated by Cockcroft-Gault formula) ≥ 50ml;
∙ patients with urinary protein ≥ + + and confirmed 24-hour urinary protein quantity \> 1.0g;
⁃ Coagulation function is good, defined as international standardized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN;
⁃ Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH is beyond the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled;
• FBG of patients without type 2 diabetes ≤ 126 mg/dL or ≤ 7.0 mmol/L, and that of patients with type 2 diabetes ≤ 167 mg/dL or ≤ 9.3 mmol/L; Or glycosylated hemoglobin (HbA1c) ≤8%;
• If there is a risk of pregnancy, all patient (male or female) are required to take appropriate methods for contraception during the study until the 6th month post the last administration of study drug;
• Well compliance, cooperate with follow-up;