Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Antibodies, Monoclonal

Pembrolizumab

Vaccines

Durvalumab

Immunoglobulins

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

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.

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

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

LK101 injection (personlized neoantigen pulsed DC vaccine )

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

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

Jie Wang, MD,PhD

Jie Wang, MD

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. The aim is to observe and evaluate the safety, tolerability and efficacy of LK101 injection combined with pembrolizumab or durvalumab respectively in the incurable NSCLC and SCLC.

This study is designed to evaluate the safety and efficacy of LK101 injection combined with pembrolizumab or durvalumab, which devided into 2 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.

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 and durvalumab (1500mg IV) Q3W in NSCLC and SCLC,respectively, until disease progression (PD), intolerable toxicity.

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

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.

incidence and severity of immune-related adverse events

incidence and severity of serious adverse events

Objective Response Rate (ORR)according to mRECIST 1.1 standard

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
LK101 Combined With PD-1 or PD-L1 Monoclonal Antibody in the Treatment of Lung Cancer	NCT05886439	Advanced Lung C...	LK101 injection... Pembrolizumab Durvalumab	18 Years -	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
LK101 Combined With PD-1 or PD-L1 Monoclonal Antibody in the Treatment of Lung Cancer	NCT05886439	Advanced Lung C...	LK101 injection... Pembrolizumab Durvalumab	18 Years -	Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Spots Global Cancer Trial Database for lk101 injection (personlized neoantigen pulsed dc vaccine )