LK101 Combined With PD-1 or PD-L1 Monoclonal Antibody in the Treatment of Lung Cancer

Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Study ID
NCT05886439
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • LK101 injection (personlized neoantigen pulsed DC vaccine ) — DRUG
    LK101 will be administered in a prime-boost schedule of 4 priming vaccination followed by 3 booster vaccinations.
  • Pembrolizumab — DRUG
    Patients will receive pembrolizumab(200mg IV) Q3W until disease progression (PD), intolerable toxicity.
  • Durvalumab — DRUG
    Patients will receive durvalumab (1500mg IV) Q3W until disease progression (PD), intolerable toxicity.
  • Tislelizumab — DRUG
    200 mg administered once every 3 weeks (Q3W) via intravenous infusion, with each infusion lasting longer than 30 minutes.

Study Details

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.

Key Dates

Start date
May 11, 2023
Status verified
Nov 2025
Primary completion
May 30, 2027
Completion
May 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LK101 injection combined with pembrolizumab
    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.
  • Experimental: LK101 injection combined with durvalumab
    patients with extensive SCLC who failed with at least first-line standard therapy. eligible subjects will receive LK101 injection and durvalumab treatment.
  • Experimental: LK101 injection combined with Tislelizumab
    Eligible subjects will receive LK101 injection and tislelizumab treatment.

Primary Outcome Measure

DLT [ Time Frame: Continuously throughout the study until 90 days after Termination of the treatment ]

Central Contacts

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