RecruitingNCT06869239

Prediction of Response to PD-L1 Inhibitor After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer Using Multi-omics-based Liquid Biopsy


Sponsor

Peking University Cancer Hospital & Institute

Enrollment

65 participants

Start Date

Feb 25, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This study aims to explore the efficacy and safety of immunotherapy (PD-L1 inhibitor) maintenance following high-dose hyperfractionated simultaneous integrated boost radiotherapy concurrent chemotherapy in patients with limited-stage small cell lung cancer (LS-SCLC). This study is a prospective observational study. Additionally, liquid biopsy technology will be employed to identify biomarkers that can predict the efficacy of PD-L1 inhibitor after chemoradiotherapy in LS-SCLC.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is using blood-based tests (liquid biopsy) and molecular analysis to predict which patients with limited-stage small cell lung cancer will respond to a type of immunotherapy (PD-L1 inhibitor) after completing chemotherapy and radiation treatment. **You may be eligible if...** - You are between 18 and 75 years old - You have been diagnosed with limited-stage small cell lung cancer (cancer confined to one side of the chest) - You have had no more than 2 cycles of chemotherapy, or no prior treatment at all - You are in good health (ECOG performance status 0 or 1) - Your blood counts, kidney, and liver function are within acceptable ranges - You have a life expectancy of at least 3 months **You may NOT be eligible if...** - Your small cell lung cancer has spread to the other side of the chest or to distant organs - You have previously received extensive cancer treatment - Your organ function is too impaired to tolerate treatment 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

DRUGEtoposide + cisplatin/carboplatin

Four courses of intravenous cisplatin (75 mg/m² of body surface area on day 1 or divided into 3 days of each cycle) or carboplatin (area under the curve of 5 mg/mL per min on day 1 of each cycle) and intravenous etoposide (100 mg/m² of body surface area on days 1-3) every 3 weeks

RADIATIONThoracic radiotherapy

High-dose, accelerated, hyperfractionated, twice-daily thoracic radiotherapy (54 Gy in 30 fractions) concurrent with chemotherapy initiated at the beginning of cycles 1-3

RADIATIONProphylactic cranial irradiation (PCI)

PCI (25Gy in 10 fractions, once daily over two weeks) 3-4 weeks post-chemoradiotherapy for patients achieving PR or CR

DRUGPD-L1 inhibitor

Maintenance therapy with PD-L1 inhibitors (Durvalumab 1500 mg Q4W or Atezolizumab 1200 mg Q3W or Sugemalimab 1200 mg Q3W or Adebrelimab 1200 mg Q3W) post-PCI until disease progression, death, or intolerable toxicity, up to 2 years


Locations(1)

Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, China

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NCT06869239


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