RecruitingPhase 2NCT06483282

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

A Single-arm, Prospective, Exploratory 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

Enrollment

38 participants

Start Date

Jun 21, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of adebrelimab (immunotherapy), apatinib (a drug that blocks blood vessel growth feeding the tumor), and chemotherapy as a pre-surgery (neoadjuvant) treatment for limited-stage small cell lung cancer — meaning the cancer is still confined to one area of the chest and may be surgically removable. **You may be eligible if...** - You are 18–75 years old - You have limited-stage small cell lung cancer confirmed by biopsy (T1–3 N0–1) - A surgeon, radiation oncologist, and radiologist have all agreed your tumor can be surgically removed - You have not had any prior treatment for this cancer - Your lung function and overall health are adequate **You may NOT be eligible if...** - You have already received any treatment for small cell lung cancer - You have another active cancer - Your lung function is significantly reduced - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdebrelimab

This product is administered by intravenously guttae. The recommended dose of subcutaneous injection is 20mg/kg, administered every 3 Weeks (Q3W).

DRUGApatinib Mesylate

This product is an orally administered targeted therapy drug, with a recommended dosage of one tablet per day.

DRUGEtoposide

This product is administered by intravenously guttae. The recommended dose of subcutaneous injection is 100mg/m2, administered every 3 Weeks (Q3W).

DRUGCarboplatin

This product is administered by intravenously guttae. AUC=5, administered every 3 Weeks (Q3W).


Locations(1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

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NCT06483282


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