Adebrelimab Plus Apatinib for Maintenance Therapy of Extensive Stage Small Cell Lung Cancer

Sponsor
Yunpeng Liu
Study ID
NCT06480864
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Adebrelimab Injection — DRUG
    Adebrelimab injection (1200mg) will be administered by intravenous infusion during the induction phase and maintenance phase on day 1 in a 3-week treatment cycle.
  • Apatinib Mesylate Tablets — DRUG
    Apatinib mesylate tablets (250 mg) will be administered orally in a 3-week treatment cycle, once a day.
  • Carboplatin — DRUG
    Carboplatin (AUC 4-5mg/mL/min) intravenous infusion will be administered during the induction phase on day 1 in a 3-week treatment cycle.
  • Cisplatin — DRUG
    Cisplatin (75mg/m2) intravenous infusion will be administered during the induction phase on day 1 in a 3-week treatment cycle.
  • Etoposide — DRUG
    Etoposide(100mg/m2) intravenous infusion will be administered during the induction phase from day 1 to 3 in a 3-week treatment cycle.

Study Details

To evaluate the efficacy and safety of maintenance therapy with Adebrelimab plus Apatinib for extensive stage small cell lung cancer after first-line induction of Adebrelimab plus chemotherapy.

Key Dates

Start date
Aug 9, 2024
Status verified
Dec 2024
Primary completion
Aug 31, 2025
Completion
Aug 31, 2026

Study Design

Enrollment
38 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Adebrelimab+Chemotherapy→Adebrelimab+ Apatinib
    Participants will receive adebrelimab plus carboplatin /cisplatin and etoposide during the induction phase (4-6 cycles of three weeks.). Thereafter, participants will receive maintenance (after induction phase) adebrelimab plus apatinib until persistent PD, intolerable toxicity or withdrawal of consent.

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: baseline up to approximately 6 month ]

Central Contacts

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