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RECRUITING
NCT05886439
PHASE1/PHASE2

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

Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-05-11

Completion Date

2028-05-30

Last Updated

2025-12-08

Healthy Volunteers

No

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.

Locations (1)

Cancer hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China