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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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. The aim is to observe and evaluate the safety, tolerability and efficacy of LK101 injection combined with pembrolizumab or durvalumab respectively in the incurable NSCLC and SCLC.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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); Both cohorts required patients progressed/recurrenced after anti-PD-1/PD-L1treatment;

• 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;

Locations
Other Locations
China
Cancer hospital Chinese Academy of Medical Sciences
RECRUITING
Beijing
Contact Information
Primary
Jie Wang, MD,PhD
jiewang_hr@sina.com
13910704669
Time Frame
Start Date: 2023-05-11
Estimated Completion Date: 2026-12-30
Participants
Target number of participants: 40
Treatments
Experimental: LK101 injection combined with pembrolizumab
patients with locally advanced or metastastic (stage IIIB-IV) NSCLC and received ≤3 lines systemtic therapy. eligible subjects will receive LK101 injection and pembrolizumab treatment.
Experimental: LK101 injection combined with durvalumab
patients with extensive SCLC who failed with at least first-line standard therapy. eligible subjects will receive LK101 injection and durvalumab treatment.
Related Therapeutic Areas
Sponsors
Leads: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

This content was sourced from clinicaltrials.gov

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