NCT05886439

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is designed to evaluate the safety and efficacy of LK101 injection combined with pembrolizumab or durvalumab, which devided into 3 cohorts: cohort 1: patients with locally advanced or metastastic (stage IIIB-IV) NSCLC who has progressed/relapsed after anti-PD-1/PD-L1 therapy. eligible subjects will receive LK101 injection and pembrolizumab treatment. cohort 2: patients with extensive SCLC who failed with at least first-line standard therapy with PD-L1. eligible subjects will receive LK101 injection and durvalumab treatment. cohort 3: patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with no driver gene mutation and PD-L1 expression and have not experienced disease progression after receiving chemotherapy combined with an anti-PD-1 therapy. LK101 will be administered in a prime-boost schedule of 4 priming vaccination followed by 3 booster vaccinations. For the priming phase: LK101 administered once a week at Days 1, 8, 15, 22. For the booster phase: total of 3 vaccinations will be given, Q3W from the end of priming dose. Treatment can be continued according to the investigator's evaluation, subsequent treatment is administered Q6W. Patients will receive a combination of pembrolizumab(200mg IV) Q3W in cohort 1, durvalumab (1500mg IV) Q3W in cohort 2, tislelizumab (200mg) Q3W, respectively, until disease progression (PD), intolerable toxicity.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-05-11
• Primary completion: 2027-05-30
• Completion: 2028-05-30
• First posted: 2023-06-02
• Last updated: 2025-12-08

Locations

1 site across 1 country: China