NCT04951063

Fraction Dose Escalation of Hypo-fractionated Radiotherapy in LANSCLC

Fraction Dose Escalation of Hypofractionated Radiotherapy With Concurrent Chemotherapy and Subsequent Consolidation Immunotherapy in Locally Advanced Non-small Cell Lung Cancer: a Phase 1 Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This Phase 1 trial aimed to determine the maximum tolerated fraction dose (MTD) of hypofractionated radiotherapy (hypo-RT) combined with concurrent chemotherapy and subsequent consolidation immune checkpoint inhibitors (cICI) for patients with locally advanced non-small cell lung cancer (LA-NSCLC).

Conditions

• Locally Advanced Lung Carcinoma

Interventions

Type	Name	Description
RADIATION	Hypofractionated radiotherapy	Split-course adaptive HRT-CHT is administered at the following three dose levels: 1. Level 1: DT 4500cGy/15 daily fractions/300cGy in the first course，DT 1500cGy/5 daily fractions/300cGy in the second course; 2. Level 2: DT 4000cGy/10 daily fractions/400cGy in the first course， DT 2000cGy/5 daily fractions/400cGy in the second course; 3. Level 3: DT 3000cGy/6 daily fractions/500cGy in the first course， DT 3000cGy/6 daily fractions/500cGy in the second course.
DRUG	Concurrent chemotherapy	weekly infusion of docetaxel (25mg/m2) and cisplatin (25mg/m2) during RT
DRUG	Consolidation immunotherapy	Consolidative immunotherapy (PD-1 or PD-L1 inhibitor) up to 1 year is administered for those without disease progression after HRT-CHT.

Timeline

• Start date: 2021-06-01
• Primary completion: 2023-03-31
• Completion: 2023-09-30
• First posted: 2021-07-06
• Last updated: 2023-12-15

Locations

1 site across 1 country: China