NCT06480864

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

Adebrelimab Plus Apatinib for Maintenance Treatment of Extensive Stage Small Cell Lung Cancer After First-line Induction with Adebrelimab Plus Chemotherapy (CLOG2402-ADAPT): a Multi-center, Single-arm, Phase 2 Clinical Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Yunpeng Liu · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a prospective, single-arm trial. 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. Induction Period: Participants received adebrelimab (1200 mg, iv., Day1) + carboplatin (AUC 4-5 mg/mL/min)/cisplatin (75 mg/m2) + etoposide (100 mg/m2, D1-3) for 4-6 cycles of three weeks. Maintenance phase: Participants received adebrelimab (1200mg, iv., Day1) + apatinib (250mg, po., daily) once every three weeks. Follow-up: After disease progression, at the discretion of the investigator, apatinib and adebrelimab can be used across lines: For platinum-sensitive patients (≥3 months from last chemotherapy): apatinib and adebrelimab plus platinum-containing two-agent chemotherapy (irinotecan/purple shirts in combination with platinum); for patients with PFS1 \>12 months: chemotherapy can be continued with the original EC/EP regimen; For platinum-resistant patients (\<3 months from last chemotherapy): apatinib and adebrelimab plus concurrent single-agent chemotherapy (irinotecan or single-agent purple shirts). The dose of chemotherapy agents was adjusted empirically by the investigators. The primary endpoint is progression-free survival (PFS). Secondary endpoints include objective remission rate (ORR), disease control rate (DCR), duration of remission (DoR), and overall survival (OS); PFS2 (defined as time from enrolment to second disease progression or death) Our study will also explore biomarkers including: haematopoietic factors (IL-6,IL-8, IL-10, etc.), PD-L1 expression, T-cell subsets, T-cell immunoprecision typing and regulatory T-cell counts. The data from our study will provide the basis for further prospective clinical trials (Phase III).

Conditions

• Small Cell Lung Cancer

Interventions

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

Timeline

• Start date: 2024-08-09
• Primary completion: 2025-08-01
• Completion: 2026-08-01
• First posted: 2024-06-28
• Last updated: 2025-01-06

Locations

2 sites across 1 country: China