A Study of Adebrelimab Combined With Apatinib Mesylate and Chemotherapy for Neoadjuvant Therapy and Biomarker Analysis in Limited-stage Small Cell Lung Cancer

Sponsor
Jin Ying
Study ID
NCT06483282
Phase
PHASE2
Status
Recruiting
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Conditions

  • Small Cell Lung Cancer Limited Stage

Eligibility Criteria

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

Interventions

  • Adebrelimab — DRUG
    This product is administered by intravenously guttae. The recommended dose of subcutaneous injection is 20mg/kg, administered every 3 Weeks (Q3W).
  • Apatinib Mesylate — DRUG
    This product is an orally administered targeted therapy drug, with a recommended dosage of one tablet per day.
  • Etoposide — DRUG
    This product is administered by intravenously guttae. The recommended dose of subcutaneous injection is 100mg/m2, administered every 3 Weeks (Q3W).
  • Carboplatin — DRUG
    This product is administered by intravenously guttae. AUC=5, administered every 3 Weeks (Q3W).

Study Details

This is a single-arm, prospective, exploratory phase II clinical study. The study enrolled newly diagnosed stage T1-3N0-1M0 resectable limited-stage small cell lung cancer. Adebrelimab combined with chemotherapy for 4 cycles and apatinib mesylate for 3 cycles. Surgery was performed within 4-8 weeks after the above treatment (the operation was performed 4 weeks after apatinib was discontinued). According to the results of MDT discussion, adebrelimab combined with apatinib mesylate combined with or without radiotherapy was started 4 weeks after surgery. Preoperative prophylactic radiotherapy (PCI) is recommended for patients with preoperative stage N1. Patients with postoperative stage N1 received postoperative thoracic radiotherapy.

Key Dates

Start date
Jun 21, 2024
Status verified
Apr 2025
Primary completion
Jun 1, 2026
Completion
Dec 31, 2026

Study Design

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

Arms

  • Experimental: Adebrelimab in combination with chemotherapy and apatinib mesylate
    Adebrelimab 1200mg q3w for 4 cycles, Apatinib mesylate 250mg qod q3w 3 times/week concurrent with adebrelimab for 3 cycles, platinum-based chemotherapy (etoposide, 100mg/m2, q3w; Carboplatin, AUC=5, q3w), 4 cycles, and operation was performed within 4-8 weeks after treatment (Apatinib mesylate was discontinued for 4 weeks). According to the results of MDT discussion, adebrelimab, 1200mg q3w, and apatinib 250mg qod q3w 3 times/week were used 4 weeks after surgery, which with or without radiotherapy. Preoperative prophylactic radiotherapy (PCI) is recommended for patients with preoperative stage N1. Patients with postoperative stage N1 received postoperative thoracic radiotherapy.

Primary Outcome Measure

EFS of 2 years [ Time Frame: Up to 2 years ]

Central Contacts