Teniposide, Cisplatin and Serplulimab for Treatment of ES-SCLC, a Randomized Controlled Study

Sponsor
Sun Yat-sen University
Study ID
NCT07583511
Phase
PHASE2
Status
Recruiting

Conditions

  • Small-cell Lung Cancer

Eligibility Criteria

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

Interventions

  • Teniposide — DRUG
    To evaluate the efficacy and safety of teniposide regimen
  • Etoposide — DRUG
    For comparison
  • serplulimab — DRUG
    Fixed regimen
  • cisplatin — DRUG
    Fixed regimen

Study Details

To compare the efficacy and safety between teniposide, cisplatin and serplulimab regimen and etoposide, cisplatin and serplulimab regimen in the treatment of extensive stage small lung cancer

Key Dates

Start date
Feb 1, 2024
Status verified
May 2026
Primary completion
May 1, 2027
Completion
Dec 1, 2027

Study Design

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

Arms

  • Experimental: teniposide, cisplatin and serplulimab
    teniposide Injection, cisplatin for injection, serplulimab injection.
  • Active Comparator: etoposide, cisplatin and serplulimab
    etoposide capsule, cisplatin for injection, serplulimab injection.

Primary Outcome Measure

Progression Free Survival [ Time Frame: 1 year ]

Central Contacts

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