At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years, male or female
- ✓Cohort 1: Locally advanced or metastatic NSCLC with ≤3 prior systemic treatment lines, progressed after anti-PD-1/PD-L1 therapy
- ✓Cohort 2: Extensive small-cell lung cancer (SCLC), progressed after anti-PD-1/PD-L1 therapy
- ✓Cohort 3: Locally advanced or metastatic NSCLC with no driver gene mutation, PD-L1 expression positive, no progression after chemotherapy combined with anti-PD-1 therapy
- ✕History of hypersensitivity to vaccines or anti-PD-1/PD-L1 ingredients, prior severe allergic reaction to monoclonal antibodies, or prior discontinuation of anti-PD-1/PD-L1 due to infusion reaction or immune-related AE
- ✕Prior therapeutic tumor vaccine products (peptide, mRNA, DC vaccine, etc.)
- ✕Diagnosis of other malignancy within 5 years (except those expected to recover after treatment)
- ✕Systemic antitumor treatment within 2 weeks before apheresis, or research drug/device therapy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating LK101 injection (personlized neoantigen pulsed DC vaccine ), Pembrolizumab, and 2 other interventions for Lung Cancer. Currently recruiting, targeting 60 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.