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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
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.
weekly infusion of docetaxel (25mg/m2) and cisplatin (25mg/m2) during RT
Consolidative immunotherapy (PD-1 or PD-L1 inhibitor) up to 1 year is administered for those without disease progression after HRT-CHT.
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China
the maximally tolerated fraction dose
The maximum tolerated fraction dose was defined as the highest DL in which \<=2 patients of the 6 treated patients experienced G3+ toxicity and \<=1 patient experienced G4+ toxicity within 12 months after RT. If a patient had multiple types of toxicities, only the highest grade of toxicity was counted.
Time frame: 1 year
Objective response rate
Proportion of patients with PR and CR at 2 months after radiotherapy
Time frame: 2 months after radiotherapy
Overall survival
Time frame: 1-year
Progression-free survival
Time frame: 1-year
Distant-metastasis free survival
Time frame: 1-year
Loco-regional recurrence-free survival
Time frame: 1-year
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