A Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab and Chemotherapy as First-Line Treatment in Advanced Squamous Non-Small Cell Lung Cancer

Sponsor
Shanghai Henlius Biotech
Study ID
NCT07318883
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Squamous NSCLC

Eligibility Criteria

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

Interventions

  • HLX07 — DRUG
    Intravenous infusion (IV), once every 3 weeks (Day 1 of each cycle \[D1\]).
  • HLX07 placebo — DRUG
    Intravenous infusion (IV), once every 3 weeks (Day 1 of each cycle \[D1\]).
  • Serplulimab — DRUG
    IV, once every 3 weeks (D1).
  • Pembrolizumab — DRUG
    IV, once every 3 weeks (D1).
  • Carboplatin — DRUG
    IV, once every 3 weeks (D1).
  • Paclitaxel or Nab-Paclitaxel — DRUG
    Paclitaxel: IV, once every 3 weeks (D1). Nab-paclitaxel: IV, once every 3 weeks (D1, 8, 15).

Study Details

The study consists of two parts: Part I is a randomized, double-blind, multicenter, parallel-controlled phase II clinical study to evaluate the efficacy and safety of HLX07 in combination with serplulimab and chemotherapy versus placebo in combination with serplulimab and chemotherapy as first-line treatment in patients with sqNSCLC. Part II is a randomized, double-blind, multicenter, parallel-controlled phase III clinical study to evaluate the efficacy and safety of HLX07 in combination with serplulimab and chemotherapy versus placebo in combination with pembrolizumab and chemotherapy as first-line treatment in patients with sqNSCLC.

Key Dates

Start date
Mar 31, 2026
Status verified
Jan 2026
Primary completion
Jan 31, 2031
Completion
Jan 31, 2031

Study Design

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

Arms

  • Experimental: Part I (phase 2)-Group A
    HLX07 + serplulimab + carboplatin + paclitaxel or nab-paclitaxel, once every 3 weeks for a total of 4 cycles, followed by maintenance therapy with HLX07 in combination with serplulimab, with serplulimab administered for up to 2 years.
  • Active Comparator: Part I (phase 2)-Group B
    Placebo + serplulimab + carboplatin + paclitaxel or nab-paclitaxel, once every 3 weeks for a total of 4 cycles, followed by maintenance therapy with placebo in combination with serplulimab, with serplulimab administered for up to 2 years.
  • Experimental: Part II (phase 3)-Group A
    HLX07 + serplulimab + carboplatin + paclitaxel or nab-paclitaxel, once every 3 weeks for a total of 4 cycles, followed by maintenance therapy with HLX07 in combination with serplulimab, with serplulimab administered for up to 2 years.
  • Active Comparator: Part II (phase 3)-Group B
    Placebo + pembrolizumab + carboplatin + paclitaxel or nab-paclitaxel, once every 3 weeks for a total of 4 cycles, followed by maintenance therapy with placebo in combination with pembrolizumab, with pembrolizumab administered for up to 2 years.

Primary Outcome Measure

ORR assessed by BICR (part I) [ Time Frame: Assessed up to appoximately 6 months from enrollment ]

Central Contacts