This study aims to evaluate a new pre-surgery (neoadjuvant) treatment for patients with stage II-III non-small cell lung cancer (NSCLC). Currently, standard pre-surgery treatment involves immunotherapy combined with chemotherapy. While effective, many patients still have residual tumor cells after this standard treatment.
Radiation therapy can not only kill tumor cells but also help the immune system recognize and fight cancer. The type of radiation used in this study is called "Quad Shot" (QS) radiotherapy. It is a short, high-dose, cyclical treatment designed to boost the effects of immunotherapy with less toxicity than standard daily radiation.
Patients in this study will receive 3 cycles of QS radiotherapy combined with Tislelizumab (an immunotherapy drug) and standard platinum-based chemotherapy before surgery. The main goal of this study is to see if this combined approach can make the tumor completely disappear under a microscope (called pathological complete response, or pCR). Researchers will also monitor the safety of the treatment, side effects, and how well patients tolerate the treatment before undergoing surgery. Approximately 12 patients will be enrolled in this study.
Age 18-75 years, either gender.
Histologically or cytologically confirmed, untreated stage II-IIIB non-small cell lung cancer (NSCLC) (including T3-4N2 IIIB, AJCC 9th edition). Baseline staging must include PET/CT (or chest + upper abdomen contrast-enhanced CT + whole body bone scan) + brain MRI. Stage III patients will be further subdivided into IIIA and IIIB per AJCC 9th edition for separate recording, evaluation, and analysis.
Evaluated as resectable by a multidisciplinary team including thoracic surgeons.
At least one evaluable target lesion per RECIST v1.1.
Known or suspected autoimmune disease (except vitiligo, Type I diabetes, or hypothyroidism requiring only hormone replacement therapy with no signs of recurrence).
Requires systemic corticosteroid therapy (>10 mg/day prednisolone or equivalent) or other immunosuppressive drugs within 14 days prior to enrollment (inhaled or topical steroids, and physiological replacement doses of adrenal corticosteroids are allowed).
History of thoracic radiotherapy.
Active bleeding before treatment.
Single group
Quad Shot Radiotherapy
Radiation3.7 Gy per fraction, twice daily (with an interval of at least 6 hours), for 4 fractions over 2 consecutive days (Days 1-2 of each cycle). Total dose of 14.8 Gy per cycle, repeated every 3 weeks for 3 cycles (cumulative dose 44.4 Gy). Delivered using IMRT or VMAT.
Tislelizumab
Drug200 mg administered via intravenous infusion on Day 3 of each 21-day cycle for 3 cycles.
Carboplatin or cisplatin
DrugCarboplatin (AUC 5) or Cisplatin (75 mg/m²) administered intravenously on Day 3 of each 21-day cycle for 3 cycles.
Pemetrexed or Paclitaxel
DrugPemetrexed (500 mg/m²) for non-squamous NSCLC or Paclitaxel (175 mg/m²) for squamous NSCLC, administered intravenously on Day 3 of each 21-day cycle for 3 cycles.
Pathological Complete Response (pCR) Rate
The proportion of patients with no residual viable tumor cells in the resected primary tumor and regional lymph nodes, as assessed by pathological review. Patients who do not undergo surgery will be considered as not achieving pCR.
Major Pathological Response (MPR) Rate
The proportion of patients with ≤10% viable tumor cells in the resected specimen.
R0 Resection Rate
The proportion of patients achieving microscopically margin-negative resection.
Objective Response Rate (ORR) per RECIST v1.1
The proportion of patients achieving a confirmed complete or partial response according to RECIST v1.1.
Event-Free Survival (EFS) and 2-Year EFS Rate
Time from enrollment to disease progression, local recurrence, distant metastasis, or death from any cause.
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