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

NCT05886439 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-12-08

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Jie Wang, MD,PhD · Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-11
Primary Completion
2027-05-30
Completion
2028-05-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05886439 on ClinicalTrials.gov