A Clinical Trial of LBL-024 Combination Drug in Patients With Advanced Solid Tumours[Substudy 01(NSCLC)]

Sponsor
Nanjing Leads Biolabs Co.,Ltd
Study ID
NCT06783647
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumour

Eligibility Criteria

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

Interventions

  • LBL-024 for Injection — DRUG
    intravenous infusion.
  • Docetaxel Injection — DRUG
    intravenous infusion.
  • Bevacizumab Injection — DRUG
    intravenous infusion.
  • Pemetrexed Disodium for Injection — DRUG
    intravenous infusion.
  • Paclitaxel Injection — DRUG
    intravenous infusion.
  • Carboplatin Injection — DRUG
    intravenous infusion.

Study Details

An open-label, multicenter, phase II clinical study to evaluate the efficacy and safety of LBL-024 in combination with other drugs for the treatment of patients with advanced solid tumour.

Key Dates

First listed
Jan 20, 2025
Start date
Jun 11, 2025
Status verified
Jan 2026
Primary completion
Dec 24, 2026
Completion
Dec 24, 2026

Study Design

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

Arms

  • Experimental: LBL-024+Docetaxel/LBL-024+Bevacizumab+Docetaxel
    Cohort 1 A： Subjects were treated with LBL-024 combined with docetaxel or LBL-024 combined with bevacizumab and docetaxel, Intravenous infusion.
  • Experimental: LBL-024+Docetaxel
    Cohort 1 B： Subjects were treated with LBL-024 combined with docetaxel, Intravenous infusion.
  • Experimental: LBL-024+Pemetrexed Disodium+Carboplatin/LBL-024+pemetrexed Disodium
    Cohort 2 A： Subjects were treated with LBL-024 combined with pemetrexed and carboplatin, after a period of time,LBL-024 and pemetrexed were used for maintenance treatment. Intravenous infusion.
  • Experimental: LBL-024+Paclitaxel+Carboplatin/LBL-024
    Cohort 2 B： Subjects were treated with LBL-024 combined with paclitaxel and carboplatin, after a period of time,LBL-024 was used for maintenance treatment. 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