Radiation with immunotherapy and chemotherapy before surgery for lung cancer

Trial details

Who runs it

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Trial code

NCT07845916

Record updated

29 September 2026

Original description

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.Read full original descriptionShow less

A Single-Arm, Prospective, Exploratory Phase II Clinical Study of Quad Shot Radiotherapy Combined With Tislelizumab and Platinum-Based Doublet Chemotherapy as Neoadjuvant Treatment for Stage II-III Non-Small Cell Lung Cancer

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.

Inclusion: 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; ECOG Performance Status 0-1; Adequate major organ function: Neutrophils ≥ 1.5×10\^9/L; Platelets ≥ 100×10\^9/L; Hemoglobin > 9.0 g/dL; Serum creatinine ≤ 1.5×ULN or Creatinine Clearance (CrCl) ≥ 40 mL/min; AST/ALT ≤ 3×ULN; Total bilirubin ≤ 1.5×ULN; INR/APTT within normal range; FEV1 ≥ 1.2L or > 40% predicted; Signed written informed consent prior to any study-related procedures; Investigator judges that the patient is able to comply with the study protocol, willing and able to follow visit schedules, treatment plans, laboratory tests, and other study procedures; Negative pregnancy test at screening (for women of childbearing potential). Subjects of childbearing potential (male and female) must agree to use effective contraception from screening until 180 days after the last dose.

Exclusion: 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); Prior or concurrent other malignancies (except cured non-melanoma skin cancer and carcinoma in situ; or malignancies in complete remission for ≥ 2 years without requiring additional anti-tumor therapy during the study period); Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or other drugs targeting T-cell costimulatory or immune regulatory pathways; Received live vaccine within 4 weeks prior to the start of study treatment; Known or suspected autoimmune disease (except vitiligo, Type I diabetes, or hypothyroidism requiring only hormone replacement therapy with no signs of recurrence); History of thoracic radiotherapy; Active bleeding before treatment; Severe heart, lung, liver, or kidney dysfunction, hematopoietic system disease, cachexia, or other conditions that make the patient unable to tolerate chemoradiotherapy; History of interstitial lung disease or non-infectious pneumonitis; Active hepatitis B (HBV DNA ≥ 2000 IU/mL or 10\^4 copies/mL) or hepatitis C (HCV antibody positive and HCV-RNA above the lower limit of detection); HIV positive or diagnosed with acquired immunodeficiency syndrome (AIDS); Known or suspected allergy to the study drugs or any related drugs in this trial; History of diabetes for more than 10 years with unsatisfactory blood glucose control; NSCLC patients with EGFR sensitizing mutations or ALK fusion genes; Pregnant or breastfeeding women; Investigator considers that the patient has other factors that may prevent completion of the study or affect subject safety or data collection.

ClinicalTrials.gov NCT07845916