NCT06586697

First-line Treatment for ES-SCLC with Chemotherapy Combined with PD-1/PD-L1 Inhibitor Sequential Thoracic Radiotherapy

Sequential Thoracic Radiotherapy for Extensive-stage Small-cell Lung Cancer Treated with Chemo-immunotherapy Followed by PD-1/PD-L1 Inhibitor Maintenance Therapy：a Phase II, Single Arm, Prospective Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single arm Phase II study designed to observe and evaluate the efficacy and safety of sequential thoracic radiotherapy in the first-line treatment of extensive small cell lung cancer with chemotherapy combined with approved PD-1/PD-L1 inhibitors.

Detailed description

This study a single arm prospective phase II study. All the enrolled patients will be patients with ES-SCLC who did not have PD after 4-6 cycle of platinum-based chemotherapy in combination with an PD-1/PD-L1 inhibitors. Then, those enrolled patients would be treated with thoracic radiotherapy concurrently with PD-1/PD-L1 maintenance therapy.

Conditions

• Extensive-stage Small-cell Lung Cancer

Interventions

Type	Name	Description
RADIATION	Thoracic Radiotherapy	Thoracic Radiotherapy (45Gy /1.5Gy/bid/3w)

Timeline

• Start date: 2023-12-01
• Primary completion: 2026-01-01
• Completion: 2026-03-20
• First posted: 2024-09-19
• Last updated: 2024-09-19

Locations

1 site across 1 country: China