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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorPeking University Cancer Hospital & Institute

About this trial

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 criteria

Qualifiers

1. Age 18-75 years, male or female;

2. Histologically or cytologically confirmed limited-stage small cell lung cancer (LS-SCLC) (AJCC, 8th edition);

3. No more than 2 cycles of chemotherapy or no previous systemic therapy;

4. ECOG PS 0-1;

Disqualifiers

1. Histological mixture of SCLC and NSCLC components;

2. Extensive-stage SCLC;

3. Patients with a history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, or those planned for transplantation;

4. Treatment with immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 14 days prior to the first dose of PD-L1 inhibitor, except for intranasal and inhaled corticosteroids or low-dose systemic steroids (i.e., ≤10 mg/day prednisolone or equivalent);

Trial design

Treatments tested in this trial

  • Etoposide + cisplatin/carboplatin
  • Thoracic radiotherapy
  • Prophylactic cranial irradiation (PCI)
  • PD-L1 inhibitor

Treatment groups

65 Participants
are divided into 1 treatment group