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

NCT05886439 | Recruiting Phase 1

• 1 other identifier: LK101-IIT02
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (4)

• DLT

  incidence of Dose limited toxicity(DLT),incidence and severity of adverse events (AEs), serious adverse events (SAEs), and immune-related adverse events (irAEs); Clinically significant abnormal changes in laboratory tests and other tests.

  Continuously throughout the study until 90 days after Termination of the treatment

• AE

  incidence and severity of adverse events

  Continuously throughout the study until 90 days after Termination of the treatment

• irAE

  incidence and severity of immune-related adverse events

  Continuously throughout the study until 90 days after Termination of the treatment

• SAE

  incidence and severity of serious adverse events

  Continuously throughout the study until 90 days after Termination of the treatment

Secondary Outcomes (8)

• ORR

  accessed up to 24 months from baseline

• DoR

  24 months

• DCR

  24 months

• TTR

  24 months

• TTP

  24 months

Other Outcomes (1)

• Tumor immune microenvironment before and after treatment

  24 months

Study Arms (3)

LK101 injection combined with pembrolizumab

EXPERIMENTAL

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.

Drug: LK101 injection (personlized neoantigen pulsed DC vaccine ); Drug: Pembrolizumab

LK101 injection combined with durvalumab

EXPERIMENTAL

patients with extensive SCLC who failed with at least first-line standard therapy. eligible subjects will receive LK101 injection and durvalumab treatment.

Drug: LK101 injection (personlized neoantigen pulsed DC vaccine ); Drug: Durvalumab

LK101 injection combined with Tislelizumab

EXPERIMENTAL

Eligible subjects will receive LK101 injection and tislelizumab treatment.

Drug: LK101 injection (personlized neoantigen pulsed DC vaccine ); Drug: Tislelizumab

Interventions

LK101 injection (personlized neoantigen pulsed DC vaccine ) DRUG

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

LK101 injection combined with Tislelizumab; LK101 injection combined with durvalumab; LK101 injection combined with pembrolizumab

Pembrolizumab DRUG

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

LK101 injection combined with pembrolizumab

Durvalumab DRUG

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

LK101 injection combined with durvalumab

Tislelizumab DRUG

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

LK101 injection combined with Tislelizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:

You may not qualify if:

• 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%;

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

pembrolizumab; durvalumab; tislelizumab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jie Wang, MD,PhD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Wang, MD,PhD

CONTACT

13910704669; jiewang_hr@sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Medical oncology

Study Record Dates

• First Submitted: May 6, 2023
• First Posted: June 2, 2023
• Study Start: May 11, 2023
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2028
• Last Updated: December 8, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)