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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
LK101 will be administered in a prime-boost schedule of 4 priming vaccination followed by 3 booster vaccinations.
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.
200 mg administered once every 3 weeks (Q3W) via intravenous infusion, with each infusion lasting longer than 30 minutes.
Cancer hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGDLT
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.
Time frame: Continuously throughout the study until 90 days after Termination of the treatment
AE
incidence and severity of adverse events
Time frame: Continuously throughout the study until 90 days after Termination of the treatment
irAE
incidence and severity of immune-related adverse events
Time frame: Continuously throughout the study until 90 days after Termination of the treatment
SAE
incidence and severity of serious adverse events
Time frame: Continuously throughout the study until 90 days after Termination of the treatment
ORR
Objective Response Rate (ORR)according to mRECIST 1.1 standard
Time frame: accessed up to 24 months from baseline
DoR
Duration of remission
Time frame: 24 months
DCR
Disease Control Rate
Time frame: 24 months
TTR
Time to remission
Time frame: 24 months
TTP
Time to progression
Time frame: 24 months
PFS
Progression Free Survival
Time frame: 24 months
OS
Overall Survival
Time frame: 24 months
Immune response evaluation
T cell response, cytokines, etc.
Time frame: 24 months
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