NCT06613308

Association Between Microbiome and the Efficacy and Safety of PD-1/PD-L1 Blockade in Resectable NSCLC

Association Between Respiratory Tract and Gut Microbiome and the Efficacy and Safety of PD-1/PD-L1 Blockade in Resectable Non-small-cell Lung Cancer: a Single-center Cohort Study

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Capital Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the relationship between respiratory and gut microbiome and PD-1/PD-L1 immune checkpoint inhibitor efficacy and immune-related adverse events (irAE) in patients with non-small cell lung cancer (Stage IIA-IIIB）

Conditions

• Lung Cancer (NSCLC)

Interventions

Type	Name	Description
DRUG	Neoadjuvant immunotherapy combined with chemotherapy	The treatment regimen consisted of a PD-1/PD-L1 monoclonal antibody in combination with a platinum-containing two-agent standard chemotherapy regimen administered every three weeks. Following two to four cycles of therapy, patients who demonstrated no evidence of disease progression were eligible for surgical resection, which was performed within three to four weeks after the conclusion of the last neoadjuvant therapy. Consolidation with a PD-1/PD-L1 monoclonal antibody was initiated within three to eight weeks after surgery and continued every three weeks. The efficacy of the treatment was evaluated according to the irRECIST criteria. Chemotherapy regimens were selected based on tumour histology and investigator judgement. In the event of poor tolerability, patients may switch between cisplatin or carboplatin treatments.
DRUG	Neoadjuvant chemotherapy	A platinum-containing two-agent standard chemotherapy regimen was administered every three weeks. Following a two-to-four-cycle therapy, if the patients were evaluated without progressive disease, patients undergo surgical resection within three to four weeks of the final neoadjuvant treatment. Postoperative adjuvant chemotherapy is then conducted in accordance with the recommended regimen outlined in the 2022 edition of the CSCO Guidelines for the Diagnosis and Treatment of Non-Small Cell Lung Cancer. The efficacy of the treatment was evaluated in accordance with the RECIST 1.1 criteria. The chemotherapy regimens were selected based on the tumor histology and the judgement of the investigators, in accordance with the standard clinical practice. In the event of poor tolerability, patients may switch between cisplatin or carboplatin treatments.

Timeline

• Start date: 2024-09-25
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2024-09-25
• Last updated: 2024-09-25