LK101 Combined With PD-1 or PD-L1 Monoclonal Antibody in the Treatment of Lung Cancer
Recruiting
Phase 1Phase 2Interventional Study
Lung Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Other
Who this trial is looking for
This trial is looking for patients with advanced lung cancer who have either not responded to previous treatments or are receiving their first treatment. Participants will receive LK101 in combination with other therapies to evaluate its safety and effectiveness.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 18 years old.
I have been diagnosed with advanced non-small cell lung cancer (NSCLC) or extensive small-cell lung cancer (ES-SCLC).
I have received previous treatments for my lung cancer.
I have a life expectancy of more than 3 months.
I have at least one measurable tumor.
My overall health rating is between 0 and 1.
I can provide informed consent to participate in the trial.
You may not be able to join if
I have a history of severe allergic reactions to vaccines or monoclonal antibodies.
I have received treatment for another cancer in the last 5 years.
I have active brain tumors or cancer in the fluid around my brain.
I have had serious heart problems or significant health issues recently.
I have active infections not controlled by treatment.
I am pregnant or breastfeeding.
I have received systemic steroids in the last 14 days.
I have uncontrolled autoimmune diseases.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 wi…
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.
Trial Locations
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Status
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 co…
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.
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