This study assesses the safety and efficacy of NK510 combined with PD-(L)1 inhibitors for relapsed/refractory advanced NSCLC, with two administration routes: intravenous infusion and intrapleural perfusion for malignant pleural effusion. Eligible patients need confirmed measurable lesions; intravenous cohort requires EGFR/ROS1/ALK negativity and disease progression after PD-(L)1 inhibitor treatment, while intrapleural cohort accepts targeted therapy-resistant patients with ≥500ml pleural effusion, and the treatment's safety, efficacy and immune microenvironment changes will be evaluated.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Intravenous infusion
Administer according to the instructions
intrapleural infusion
Administer according to the instructions
Jinling hospital, affiliated to Medical school Nanjing University
Nanjing, Jiangsu, China
RECRUITINGDose-limiting toxicity and incidence of adverse events
To evaluate DLT and the incidence of AEs associated with NK510 treatment
Time frame: 6 weeks
Objective Response Rate
For intravenous groups: Proportion of subjects achieving CR and PR according to RECIST v1.1 after first NK510 administration; For pleural perfusion groups: Proportion of subjects achieving CR and PR according to WHO criteria after first NK510 intrapleural perfusion.
Time frame: 6 weeks
Progression-Free Survival
Time from first NK510 administration to disease progression or death.
Time frame: From the date of the first dose of NK510 until disease progression, death, or a maximum of 24 months after the first dose, whichever occurs first.
Puncture-Free Survival
Time from last treatment puncture to next puncture drainage (for pleural perfusion groups).
Time frame: From the date of the last treatment puncture to the date of the next puncture drainage, or up to a maximum of 24 months after the last treatment puncture, whichever occurs first.
Duration of Response
Time from achievement of response to disease progression.
Time frame: From the date of first documentation of objective response to disease progression, death, or a maximum of 24 months after the date of first response, whichever occurs first.
Disease Control Rate
Proportion of subjects achieving CR, PR or SD based on baseline tumor assessment.
Time frame: From baseline tumor assessment up to the earliest of disease progression,or a maximum of 24 months after baseline.
Overall Survival
Time from screening enrollment to death.
Time frame: From the date of screening enrollment to death, or a maximum of 24 months after screening enrollment, whichever occurs first.
Health-Related Quality of Life
Assessed by EORTC QLQ-C30 (V3.0) scale.
Time frame: At screening, every 6 weeks during treatment, at study completion, or up to a maximum of 24 months after the first dose, whichever occurs first.
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