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NOT YET RECRUITING
NCT07845916
PHASE2

Quad Shot Radiotherapy Combined With Tislelizumab and Platinum-Based Chemotherapy Before Surgery for Stage II-III Non-Small Cell Lung Cancer

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

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2026-10-10

Completion Date

2031-12-31

Last Updated

2026-09-29

Healthy Volunteers

No

Interventions

RADIATION

Quad Shot Radiotherapy

3.7 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.

DRUG

Tislelizumab

200 mg administered via intravenous infusion on Day 3 of each 21-day cycle for 3 cycles.

DRUG

Carboplatin or cisplatin

Carboplatin (AUC 5) or Cisplatin (75 mg/m²) administered intravenously on Day 3 of each 21-day cycle for 3 cycles.

DRUG

Pemetrexed or Paclitaxel

Pemetrexed (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.

Locations (1)

Wuhan Union Hospital

Wuhan, Hubei, China