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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

LK101 Combined With PD-1 or PD-L1 Monoclonal Antibody in the Treatment of Lung Cancer

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

LK101 Combined With PD-1 or PD-L1 Monoclonal Antibody in the Treatment of Lung Cancer (NCT05886439) is a Phase 1 / Phase 2 interventional studying Lung Cancer, sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Lung Cancer, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 60 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Lung Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - signed willing to sign a consent form; - ≥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 your organs (liver, kidneys, etc.) are working well enough based on blood tests, 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; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

LK101 injection (personlized neoantigen pulsed DC vaccine )

LK101 will be administered in a prime-boost schedule of 4 priming vaccination followed by 3 booster vaccinations.

DRUG

Pembrolizumab

Patients will receive pembrolizumab(200mg IV) Q3W until disease progression (PD), intolerable toxicity.

DRUG

Durvalumab

Patients will receive durvalumab (1500mg IV) Q3W until disease progression (PD), intolerable toxicity.

DRUG

Tislelizumab

200 mg administered once every 3 weeks (Q3W) via intravenous infusion, with each infusion lasting longer than 30 minutes.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Cancer hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05886439), the sponsor (Cancer Institute and Hospital, Chinese Academy of Medical Sciences), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05886439 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05886439?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05886439?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05886439. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05886439. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.