Actively Recruiting
LK101 Combined With PD-1 or PD-L1 Monoclonal Antibody in the Treatment of Lung Cancer
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-12-08
60
Participants Needed
1
Research Sites
263 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
LK101 Combined With PD-1 or PD-L1 Monoclonal Antibody in the Treatment of Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Age 18 years or older, male or female
- Cohort 1: Histologically or cytologically confirmed locally advanced or metastatic NSCLC with up to 3 prior systemic treatments after recurrence or metastasis
- Cohort 2: Histologically or cytologically confirmed extensive small-cell lung carcinoma (ES-SCLC) with progression after anti-PD-1/PD-L1 therapy
- Cohort 3: Histologically or cytologically confirmed locally advanced or metastatic NSCLC without driver gene mutations, with PD-L1 expression, and no disease progression after chemotherapy plus anti-PD-1 therapy
- Life expectancy longer than 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- At least one measurable lesion according to RECIST 1.1 criteria
- Qualified tumor sequencing
- Suitable venous access for apheresis as judged by investigator
- Adequate organ function meeting specified laboratory criteria for blood counts, liver, kidney, coagulation, and thyroid function
- Blood glucose and HbA1c within specified limits depending on diabetes status
- Use of effective contraception during the study and for 6 months after last study drug administration if pregnancy risk exists
- Willingness and ability to comply with study procedures and follow-up
You will not qualify if you...
- History of severe allergic reaction to vaccines or anti-PD-1/PD-L1 agents or other monoclonal antibodies
- Prior discontinuation of anti-PD-1/PD-L1 therapy due to infusion reactions or immune-related adverse events
- Previous treatment with therapeutic tumor vaccines
- Diagnosis of other malignant diseases within 5 years, except those expected to be cured
- Systemic antitumor treatment or research drugs within 2 weeks before apheresis
- Radiotherapy within 2 weeks before screening
- Unresolved treatment toxicities above grade 1 except hair loss and peripheral neuropathy
- Tumor compressing vital organs or invading major blood vessels
- History of allogeneic stem cell or organ transplantation
- History of seizures requiring antiepileptic treatment
- Active brain metastases or cancerous meningitis unless stable and treated at least 3 months prior
- Active or suspected autoimmune disease
- Poorly controlled pleural, pericardial effusion, or ascites needing repeated drainage
- Significant cardiovascular or cerebrovascular disease within 6 months including abnormal QTc, low heart function, severe arrhythmia, uncontrolled hypertension
- Interstitial pneumonia except inactive cases not needing hormone therapy
- Active infections not controlled by treatment
- Positive tests for HIV, syphilis, hepatitis B or C, or COVID-19
- Active tuberculosis
- Use of systemic steroids or immunosuppressants within 14 days before screening
- Vaccination within 4 weeks before screening
- Major injury or surgery within 4 weeks before screening
- History of substance abuse or mental disorders affecting compliance
- Pregnant or breastfeeding women
- Skin diseases that prevent intradermal vaccine delivery
- Other conditions deemed exclusionary by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
J
Jie Wang, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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