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.
Signed and Dated Informed Consent: Written informed consent must be provided prior to any study procedures, with the consent form signed and dated by the participant.
Age Range: Male or female patients aged 18 to 75 years.
Diagnosis: Patients must have locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC), with histological or cytological confirmation of the diagnosis.
Previous Treatment: Patients must not have received prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy.
Concurrent participation in another clinical trial, except for observational (non-interventional) studies.
Histological subtype of mixed small-cell and non-small-cell lung cancer. Use of immunosuppressive drugs within 28 days before treatment, except for intranasal or inhaled corticosteroids at physiological doses or systemic corticosteroids ≤10 mg/day of prednisone or equivalent.
Prior treatment with anti-PD-1 or anti-PD-L1 antibodies.
Major surgery within 4 weeks prior to enrollment (excluding procedures for vascular access).
Parallel
Neoadjuvant therapy
DrugThe 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.
Hypo-RT and concurrent chemotherapy
RadiationDefinitive dose of hypofractionated thoracic radiotherapy with concurrent chemotherapy
CFRT and concurrent chemotherapy
RadiationDefinitive dose of conventionally fractionated thoracic radiotherapy with concurrent chemotherapy
Consolidative immunotherapy
DrugFollowing 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.
Progression-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.
Objective Response Rate (ORR)
ORR refers to the proportion of patients who experience complete response (CR) and partial response (PR)
Overall survival (OS)
OS is the time from the start of treatment until death from any cause.
Failure patterns
Failure patterns describe the pattern of disease progression or treatment failure, such as local recurrence or distant metastases
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.
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