NCT05886439 LK101 Combined With PD-1 or PD-L1 Monoclonal Antibody in the Treatment of Lung Cancer
| NCT ID | NCT05886439 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Condition | Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-05-11 |
| Primary Completion | 2027-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2023-05-11 with a primary completion date of 2027-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 (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.
Eligibility Criteria
Inclusion Criteria: * 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; Exclusion Criteria: * History of hypersensitivity reaction to any vaccine and/or anti-PD-1/PD-L1 formulation ingredients; Or have had a previous severe allergic reaction to other monoclonal antibodies; Subjects who had previously discontinued anti-PD-1 /PD-L1 therapy due to "infusion reaction" or immune-related AE; * Patients who have received therapeutic tumor vaccine products (including peptide vaccine, mRNA vaccine, DC vaccine, etc.); * Diagnosis of malignant diseases other than study disease within 5 years before screening (except for malignant tumors that can be expected to recover after treatment); * Patients received systemic antitumor treatment within 2 weeks before the apheresis, or receive reasearch drugs or device therapy; * Received radiotherapy within 2 weeks prior to screening; * Toxicity caused by previous treatment did not recover to CTCAE (version 5.0) Grade 1 or below (except hair loss and peripheral neuropathy); * The tumor compresses the surrounding important organs or the superior vena cava, or invades the mediastinal great blood vessels, the heart, .etc; * Patients who have recewived allogeneic hematopoietic stem cell transplantation or organ transplantation; * A history of medical conditions that may trigger seizures (requiring treatment with antiepileptic medications); * Patients who have active brain metastases or cancerous meningitis. Patients with treated brain metastases are eligible if they have been treated with brain metastases, and clinically stable for atleast 3 months, no evidence of disease progression 4 weeks before. All neurological symptoms had recovered, and off steroids at least 7 days prior to screening; * Diaginosied or suspected of having an active autoimmune disease; * patients with poorly controlled pleural effusion, pericardial effusion, or ascites requiring repeated drainage, or received pleural effusion or ascites treatment within the past 3 months; * History of significant cardiovascular and cerebrovascular disease occurred in the 6 months prior to screening,Any of the following cardiac criteria: * Mean resting corrected QT interval (QTc) \> 470 ms; * Left ventricular ejection fraction (LVEF) ≤ 50%; * American New York heart association (NYHA) heart function ≥ 2 or higher; * serious arrhythmia; * poorly controlled hypertension; * other serious heart disease; * Patients with interstitial pneumonia, except those inactive and do not require hormone therapy disease; * Patients diagnosed with active infections that are poorly controlled by systemic treatment; * Any of the following test results are positive: human immunodeficiency virus (HIV) antibody, treponema pallidum antibody, hepatitis C virus (HCV) antibody, hepatitis B virus (HBV) surface antigen (HBsAg), HBV DNA and novel coronavirus nucleic acid; * Active tuberculosis (TB) during screening; * Treatment with systemic steroids or other immunosuppressive agents within 14 days prior to screening; * Vaccination within 4 weeks prior to screening; * Major injuries and/or surgery =\< 4 weeks prior to screening; * Persons with a history of psychotropic substance abuse and inability to abstain or with a history of mental disorders; * Pregnant or lactating women; * Skin diseases, such as psoriasis, may prevent intradermal vaccines from reaching the target area; * Other conditions regimented at investigators' discretion.
Contact & Investigator
Jie Wang, MD,PhD
PRINCIPAL INVESTIGATOR
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Frequently Asked Questions
Who can join the NCT05886439 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05886439 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05886439 currently recruiting?
Yes, NCT05886439 is actively recruiting participants. Contact the research team at jiewang_hr@sina.com for enrollment information.
Where is the NCT05886439 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT05886439 clinical trial?
NCT05886439 is sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The principal investigator is Jie Wang, MD,PhD at Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The trial plans to enroll 60 participants.
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