A Clinical Trial of LBL-024 Combined With Etoposide and Platinum in Patients With Advanced Neuroendocrine Carcinoma

Sponsor
Nanjing Leads Biolabs Co.,Ltd
Study ID
NCT06157827
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Advanced Neuroendocrine Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • LBL-024 for Injection — DRUG
    intravenous infusion
  • Etoposide Injection — DRUG
    intravenous infusion
  • Carboplatin Injection — DRUG
    intravenous infusion
  • Atezolizumab injection — DRUG
    intravenous infusion
  • Cisplatin injection — DRUG
    intravenous infusion

Study Details

An open-label, multicenter phase Ib/II clinical study to evaluate the safety and efficacy of LBL-024 combined with etoposide and platinum in the first-line treatment of patients with advanced neuroendocrine carcinoma (NEC)

Key Dates

Start date
Dec 8, 2023
Status verified
Mar 2026
Primary completion
Dec 28, 2026
Completion
Mar 28, 2027

Study Design

Enrollment
178 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LBL-024+Etoposide+Carboplatin/Cisplatin
    LBL-024+Etoposide+Carboplatin/Cisplatin Intravenous infusion.
  • Active Comparator: Atezolizumab+Etoposide+Carboplatin
    Atezolizumab+Etoposide+Carboplatin Intravenous infusion.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: From all subjects signed the informed consent form up to the completion of the follow-up period of drug withdrawal (28 days after drug withdrawal or before the start of new anti-tumor therapy). ]

Central Contacts

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