Testing the Addition of Radiation Therapy to the Immune Therapy Treatment for ES-SCLC

Sponsor
Zhejiang Cancer Hospital
Study ID
NCT06350162
Phase
PHASE2
Status
Unknown

Conditions

  • Extensive Stage Lung Small Cell Cancer

Eligibility Criteria

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

Interventions

  • Serplulimab — DRUG
    4.5mg/kg,IV over 30 minutes +/- 10 minutes on day 1. Cycles repeat every 21 days.
  • Chest Radiation — RADIATION
    30Gy-45Gy/QD/3Gy

Study Details

This phase II trial compares the effect of adding radiation therapy to the usual maintenance therapy with Serplulimab versus Serplulimab alone in patients who have already received Serplulimab plus chemotherapy for the treatment of extensive stage small cell lung cancer .

Key Dates

Start date
Oct 18, 2023
Status verified
Apr 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2025

Study Design

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

Arms

  • Experimental: Serplulimab+Radiation Therapy
    Patients receive Serplulimab IV over 30 minutes +/- 10 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo radiation therapy QD on days 1-5 during weeks 1-3 only. Patients undergo PET/CT scan, CT, and MRI throughout the trial. Patients also undergo blood and tissue collection throughout the trial.
  • Active Comparator: Serplulimab
    Patients receive Serplulimab IV over 30 minutes +/- 10 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo PET/CT scan, CT, and MRI throughout the trial. Patients also undergo blood and tissue collection throughout the trial.

Primary Outcome Measure

1-year Progression-free survival rate [ Time Frame: up to 1year ]

Central Contacts

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