Consolidative immunotherapy following concurrent chemoradiotherapy, based on the PACIFIC trial, has become the standard treatment for locally advanced non-small cell lung cancer (LANSCLC). Radiotherapy strategies for maximizing efficacy and local control require further investigation. This phase III, randomized controlled clinical trial is to investigate the efficacy and safety of hypofractionated chemoradiotherapy followed by consolidative immunotherapy versus conventional fractionated chemoradiotherapy followed by consolidative immunotherapy in LANSCLC patients.
This phase III, randomized controlled trial aims to investigate the efficacy and safety of hypofractionated chemoradiotherapy followed by consolidative immunotherapy versus conventional fractionated chemoradiotherapy followed by consolidative immunotherapy in LANSCLC patients. Patients will be randomized in a 2:1 ratio to the following two groups: (1) Study group: Patients in this group will undergo hypofractionated chemoradiotherapy, followed by consolidative immunotherapy for a maximum duration of 12 months. (2) Control group: Patients in this group will receive conventional fractionated chemoradiotherapy followed by consolidative immunotherapy for a maximum duration of 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
311
All patients will receive split-course hypofractionated radiotherapy. First course of radiotherapy: Total dose of 4000 cGy in 10 daily fractions (400 cGy per fraction) or 3000 cGy in 6 daily fractions (500 cGy per fraction). Three weeks after the completion of the first course of hypofractionated radiotherapy, tumor response and toxicity will be evaluated. For patients who achieve a partial response and without grade 2 or higher respiratory toxicity, a second course of radiotherapy will be planned for the residue disease at a total dose of 2000 \~2400 cGy in 5\~6 fractions (400 cGy per fraction). The interval between the two courses of radiotherapy will be 28 days.
Patients in this group will receive a total dose of 6000- 6400 cGy in 30- 32 fractions, with 200 cGy per fraction.
Paclitaxel plus platinum-based chemotherapy.
Paclitaxel plus platinum-based chemotherapy or pemetrexed plus platinum-based chemotherapy.
Following the completion of chemoradiotherapy, PD-1/PD-L1 immune checkpoint inhibitor consolidation therapy will be administered for up to 12 months.
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGGansu Provincial Cancer Hospital
Lanzhou, Gansu, China
RECRUITINGSun yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGMedian Progression-Free Survival
PFS measures the time from the start of treatment until the disease progresses or the patient dies from any cause, whichever occurs first.
Time frame: 2 years
Objective Response Rate (ORR)
ORR refers to the proportion of patients who experience complete response (CR) and partial response (PR)
Time frame: 1-2 months after treatment
Overall survival (OS)
OS is the time from the start of treatment until death from any cause.
Time frame: 2 years
Failure patterns
Failure patterns describe the pattern of disease progression or treatment failure, such as local recurrence or distant metastases.
Time frame: 2 years
Safety: Adverse Events
Safety endpoints assess the frequency and severity of treatment-related adverse events. Adverse events are graded on a scale from 1 to 5 according to CTCAE 5.0.
Time frame: 1 years after treatment
Quality of life assessed by Quality of Life Core 30
Patient-reported quality of life measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). Higher scores on functioning scales indicate better functioning, while higher scores on symptom scales indicate more severe symptoms.
Time frame: 1 years after treatment
Quality of life assessed by Quality of Life LC13
Patient-reported quality of life measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-LC13). Higher scores on functioning scales indicate better functioning, while higher scores on symptom scales indicate more severe symptoms.
Time frame: 1 years after treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.