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Neoadjuvant Adebrelimab in Resectable SCLC: A Randomized Trial

NCT06485544 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2024-07-03

No results posted yet for this study

Summary

This study is a randomized, open-label, multicenter exploratory research aiming to evaluate the efficacy and safety of Adebrelimab in combination with chemotherapy (etoposide and platinum-based therapy) as neoadjuvant treatment for resectable stage I-IIIB (stage IIIB limited to T1-4N1-2M0) small cell lung cancer (SCLC). The study is primarily conducted at Tangdu Hospital of the Fourth Military Medical University. A total of 104 patients with stage IA-IIIB SCLC (stage IIIB limited to T1-4N1-2M0) will be enrolled and randomized 1:1 to receive either Adebrelimab plus chemotherapy or chemotherapy alone. Each patient will undergo 3 cycles of study treatment followed by a 3-4 week break before surgery. Treatment will be discontinued if patients experience disease progression, intolerable drug-related adverse events, withdrawal of informed consent, or other specified conditions during the study. Effectiveness and safety outcomes will be monitored throughout the trial. The primary objective is to evaluate pathological complete response (pCR) with Adebrelimab combination therapy. Secondary objectives include assessing event-free survival (EFS), major pathological response (mPR), objective response rate (ORR), disease-free survival (DFS), and safety.

Conditions

  • Small Cell Lung Cancer (SCLC)

Interventions

DRUG

Adebrelimab + Etoposide + Platinum-based Therapy

Intervention Description for Treatment Group: This intervention includes Adebrelimab in combination with Etoposide and Platinum-based therapy as neoadjuvant treatment for resectable small cell lung cancer (SCLC). Adebrelimab is administered intravenously at a fixed dose of 1200 mg over 30 minutes on Day 1 of each 3-week cycle, followed by Etoposide at a dose of 100 mg/m2 via intravenous infusion over 30 minutes on Days 1 to 3 of each cycle. Concurrently, Platinum-based therapy (either Cisplatin at AUC5 or Carboplatin at AUC5 or Cisplatin at 100 mg/m2) is administered via intravenous infusion on Day 1 of each cycle. The treatment regimen consists of 3-4 cycles, with a 4-6 week drug-free interval before surgical treatment.

DRUG

Etoposide + Platinum-based Therapy

Intervention Description for Control Group: This intervention includes Etoposide in combination with Platinum-based therapy as neoadjuvant treatment for resectable small cell lung cancer (SCLC). Etoposide is administered at a dose of 100 mg/m2 via intravenous infusion over 30 minutes on Days 1 to 3 of each 3-week cycle. Concurrently, Platinum-based therapy (either Cisplatin at AUC5 or Carboplatin at AUC5 or Cisplatin at 100 mg/m2) is administered via intravenous infusion on Day 1 of each cycle. The treatment regimen consists of 3-4 cycles, with a 4-6 week drug-free interval before surgical treatment.

Sponsors & Collaborators

  • Tang-Du Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2025-12-30
Completion
2026-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06485544 on ClinicalTrials.gov