A Clinical Study to Evaluate the Efficacy and Safety of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab and Chemotherapy in Previously Untreated Advanced NSCLC Patients

Sponsor
Shanghai Henlius Biotech
Study ID
NCT05787613
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • NSCLC Stage IV

Eligibility Criteria

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

Interventions

  • HLX26 — DRUG
    Anti-LAG-3 monoclonal Antibody Injection
  • Serplulimab — DRUG
    anti-PD-1 humanized monoclonal antibody injection
  • Chemotherapy drug — DRUG
    non-squamous NSCLC patients will receive Pemetrexed 500mg/m2, IV, Q3W. Carboplatin AUC 5mg/mL/min, IV, Q3W, up to 4 cycles.squamous NSCLC patients will receive Albumin-paclitaxel 100mg/m2, IV, Q1W or paclitaxel 175mg/m2, IV, Q3W and carboplatin AUC 5 mg/mL/min, IV, Q3W, up to 4 cycles.
  • Placebo — DRUG
    placebo

Study Details

A Phase II Study to Evaluate the Efficacy, Safety and Tolerability of HLX26 (Anti-LAG-3 Monoclonal Antibody Injection) Combined With Serplulimab (Anti-PD-1 Humanized Monoclonal Antibody Injection) and Chemotherapy in Previously Untreated Advanced Non-small Cell Lung Cancer (NSCLC) Patients

Key Dates

Start date
Jul 10, 2023
Status verified
Aug 2025
Primary completion
Feb 28, 2026
Completion
Jul 31, 2027

Study Design

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

Arms

  • Experimental: HLX26 MTD + serplulimab 300 mg + chemotherapy intravenous infusion Q3W
    In this group, HLX26 (MTD) in combination with HLX10 (300 mg) and chemotherapy will be intravenously administered every 3 weeks. About 40 subjects will be enrolled in this cohort. Patients will be treated with until disease progression, death, receiving new antitumor treatment, intolerable toxicity or withdrawal of informed consent (whichever occurs first). The efficacy of HLX26 (MTD) in combination with Serplulimab and chemotherapy will be evaluated in this group.
  • Experimental: HLX26 MTD-1 + serplulimab 300 mg + chemotherapy intravenous infusion Q3W
    In this group, HLX26 (MTD-1) in combination with HLX10 (300 mg) and chemotherapy will be intravenously administered every 3 weeks. About 40 subjects will be enrolled in this cohort. Patients will be treated with until disease progression, death, receiving new antitumor treatment, intolerable toxicity or withdrawal of informed consent (whichever occurs first). The efficacy of HLX26 (MTD-1) in combination with Serplulimab and chemotherapy will be evaluated in this group.
  • Placebo Comparator: placebo + serplulimab 300 mg + chemotherapy intravenous infusion Q3W
    In this group, placebo in combination with HLX10 (300 mg) and chemotherapy will be intravenously administered every 3 weeks. About 40 subjects will be enrolled in this cohort. Patients will be treated with until disease progression, death, receiving new antitumor treatment, intolerable toxicity or withdrawal of informed consent (whichever occurs first). The efficacy of Serplulimab and chemotherapy will be evaluated in this group.

Primary Outcome Measure

Dose-limiting toxicity (DLT) (Part 1) [ Time Frame: from day1 to day 21 ]

Related Studies