Consolidative immunotherapy following concurrent chemoradiotherapy, based on the PACIFIC trial, has become the standard treatment for locally advanced non-small cell lung cancer (LANSCLC), leading to a 5-year survival rate of over 40%. The optimal timing of radiotherapy combined with immunotherapy still requires further exploration. This phase III, randomized controlled clinical trial is to investigate the efficacy and safety of neoadjuvant immuno-chemotherapy followed by concurrent chemoradiotherapy and consolidative immunotherapy, compared with concurrent chemoradiotherapy and consolidative immunotherapy in LANSCLC patients.
This phase III, randomized controlled trial aims to investigate the efficacy and safety of neoadjuvant immuno-chemotherapy followed by concurrent chemoradiotherapy and consolidative immunotherapy, compared with concurrent chemoradiotherapy and consolidative immunotherapy in LANSCLC patients. Patients will be randomized in a 2:2:1 ratio to the following three groups: Group A: Patients will receive neoadjuvant chemo-immunotherapy. After neoadjuvant therapy, they will undergo hypofractionated radiotherapy (hypo-RT) and concurrent chemotherapy, followed by consolidative immunotherapy for a maximum duration of 12 months. (2) Group B: Patients will receive neoadjuvant chemo-immunotherapy. After neoadjuvant therapy, they will undergo conventionally fractionated radiotherapy (CFRT) and concurrent chemotherapy, followed by consolidative immunotherapy for a maximum duration of 12 months. (3) Group C: Patients will receive CFRT and concurrent chemotherapy, followed by consolidative immunotherapy for a maximum duration of 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
497
The neoadjuvant regimen prior to radiotherapy consists of albumin-bound paclitaxel 260 mg/m², cisplatin 75 mg/m², and tislelizumab 200 mg, administered every 3 weeks.
Definitive dose of hypofractionated thoracic radiotherapy with concurrent chemotherapy
Definitive dose of conventionally fractionated thoracic radiotherapy with concurrent chemotherapy
Following the completion of chemoradiotherapy, Tislelizumab consolidation therapy will be administered based on treatment efficacy and the patient's physical condition, for a total duration of 1 year, starting 1-2 months after chemoradiotherapy.
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGProgression-Free Survival rate
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: 18-months
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 of Grade 2 or Higher
Safety endpoints assess the frequency and severity of treatment-related adverse events (side effects). Adverse events are graded on a scale from 1 to 5, with grade 2 and above indicating more significant side effects that may require medical intervention or treatment modifications.
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
The percentage of patients who are eligible for consolidative immunotherapy following chemoradiotherapy
The percentage of patients who are eligible for consolidative immunotherapy following chemoradiotherapy
Time frame: 1 year
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