NCT05549037

Effect of Time-of-Day (ToD) for Immunochemotherapy on PFS in NSCLC

Progression Survival Time According to Time-of-Day (ToD) of Administration of Immunochemotherapy for Advanced Non-small Cell Lung Cancer: A Phase III Randomized Control Trial

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (estimated)
• Sponsor: Hunan Province Tumor Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study aims to explore time-of-day of administration of immunochemotherapy on the efficacy for treatment naive advanced non-small cell lung cancer.

Detailed description

All the advanced NSCLC patients who were treated with chemotherapy plus pembrolizumab or sitilimab will be randomized to two groups. One for morning group, the patients in this group were treated with chemotherapy plus pembrolizumab or sintilimab before 15:00. One for afternoon group, the patients in this group were treated with chemotherapy plus pembrolizumab or sintilimab after 15:00.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Pembrolizumab, Sintilimab	One for morning group, the patients in this group were treated with immunochemotherapy before 15:00. One for afternoon group, the patients in this group were treated with immunochemotherapy after 15:00.

Timeline

• Start date: 2022-09-23
• Primary completion: 2024-12-02
• Completion: 2025-12-31
• First posted: 2022-09-22
• Last updated: 2025-02-19

Locations

1 site across 1 country: China