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Not yet taking people in ChinaPhase 2

Radiation, immunotherapy and chemotherapy before surgery for large lung tumors

Tests spatially fractionated radiation with tislelizumab and chemotherapy before surgery in lung cancer.

Key facts

Who runs it
Sichuan Cancer Hospital and Research Institute
Where
Chengdu, ChinaSee the site
Trial code
Registry title
Spatially Fractionated Radiotherapy With Tislelizumab and Chemotherapy for Bulky Stage III NSCLC: A Phase II Trial
Status
Not yet recruiting
Phase
Phase 2
People taking part
43 people, planned
Started
20 Aug 2026
Expected to end
30 Jun 2030
Type of study
Interventional
Treatments tested
  • Spatially Fractionated Radiotherapy (SFRT)
  • Tislelizumab
  • Carboplatin
  • Cisplatin
  • Pemetrexed
  • Paclitaxel
  • Radical Lung Resection Surgery
Record updated
20 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with bulky stage III non-small cell lung cancer (primary tumor larger than 5 cm (2 in)) that doctors think can be removed by surgery and that has not been treated before.

Age
18 to 75 years (inclusive).
Sex
All sexes can join.
Disease stage
Stage III non-small cell lung cancer, confirmed by cytology or histology, with a primary tumor >5 cm (2 in) (T3-T4), N0-N2, considered potentially resectable by a multidisciplinary team including a thoracic surgeon.
Earlier treatment
No prior chemotherapy, radiotherapy, surgery, or immunotherapy. No prior thoracic radiotherapy. No prior anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or other immune checkpoint treatment.
Biomarker or test result
Cancer with known EGFR-sensitizing mutations, ALK fusion gene, or ROS1 rearrangement cannot join.

Main reasons for not taking part

  • Autoimmune disease, or suspected autoimmune disease (some mild cases may join)
  • Interstitial lung disease or non-infectious pneumonitis
  • Another cancer, unless in complete remission for ≥2 years
  • Active hepatitis B or hepatitis C, or HIV-positive or AIDS
  • Pregnant or breastfeeding women

The registry criteria, word for word

Show all 20 criteriaShow less

Who can take part

  • Voluntary agreement to participate and signed written informed consent
  • Cytologically or histologically confirmed (via percutaneous lung biopsy, bronchoscopy, mediastinoscopy, etc.) bulky stage III non-small cell lung cancer (NSCLC) per AJCC 9th edition staging, with primary tumor >5 cm (T3-T4), N0-N2, and no prior chemotherapy, radiotherapy, surgery, or immunotherapy
  • Pulmonary lesion considered potentially resectable by a multidisciplinary team (MDT) including a thoracic surgeon
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
  • Adequate hematologic and organ function as demonstrated by:; Absolute neutrophil count ≥ 1,500 × 10⁹/L; Platelet count ≥ 100 × 10⁹/L; Hemoglobin > 9.0 g/dL; Serum creatinine ≤ 1.5 × upper limit of normal (ULN) or creatinine clearance (CrCl) ≥ 40 mL/min; AST/ALT ≤ 3 × ULN; Total bilirubin ≤ 1.5 × ULN; FEV1 ≥ 1.2 L or > 40% of predicted value; INR/APTT within normal limits; -Age 18 to 75 years (inclusive)

Who cannot take part

  • Prior history of thoracic radiotherapy
  • Active bleeding prior to treatment
  • Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4, or other agents targeting T-cell co-stimulation or immune checkpoint pathways
  • Has or is suspected of having an autoimmune disease. Note: patients with vitiligo, type I diabetes mellitus, or hypothyroidism (Hashimoto's thyroiditis) requiring only hormone replacement therapy may be enrolled if no significant signs of recurrence are present
  • Requires systemic corticosteroid therapy (>10 mg prednisone or equivalent per day) or other immunosuppressive agents within 14 days after enrollment. Note: inhaled or topical corticosteroids, or adrenal hormone replacement therapy (>10 mg prednisone or equivalent per day) for patients without active autoimmune disease, are permitted
  • Severe cardiac, pulmonary, hepatic, renal, or hematopoietic dysfunction, cachexia, or any condition that would preclude tolerance to radiochemotherapy
  • History of interstitial lung disease or non-infectious pneumonitis
  • Active hepatitis B (HBV DNA ≥ 2000 IU/mL or ≥ 10⁴ copies/mL) or hepatitis C (anti-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 to any agent used in this trial
  • History of diabetes mellitus for >10 years with poorly controlled blood glucose
  • NSCLC with known EGFR-sensitizing mutations, ALK fusion gene, or ROS1 rearrangement
  • History of another malignancy (excluding non-melanoma skin cancer and carcinoma in situ of the bladder, stomach, colon, endometrium, cervix, melanoma, or breast) unless the malignancy has been in complete remission for ≥2 years and no additional anti-tumor therapy is required during the study period
  • In the investigator's opinion, medically, psychologically, or physically unable to complete the study or to understand the patient information
  • Pregnant or breastfeeding women

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in China

  • Sichuan Cancer HospitalChengdu, ChinaContact: bin huNo longer taking part

About the trial

What the trial wants to find out

This is a prospective, single-arm, multicenter phase II clinical study evaluating the efficacy and safety of spatially fractionated radiotherapy (SFRT) combined with tislelizumab and platinum-based doublet chemotherapy as induction/conversion therapy for patients with potentially resectable stage III non-small cell lung cancer (NSCLC) with bulky disease (primary tumor >5 cm).

Read full original descriptionShow less

SFRT, also known as lattice radiation therapy, is a novel radiotherapy technique that creates alternating high-dose and low-dose regions within the tumor. This approach not only reduces tumor burden but also may enhance anti-tumor immune responses, potentially working synergistically with immunotherapy.

Study participants will receive SFRT to the primary lung tumor (GTV 20 Gy/5 fractions, GTV-Lattice 60 Gy/5 fractions), followed by 2-4 cycles of tislelizumab (200 mg, Q3W) combined with platinum-based doublet chemotherapy. Surgery will be performed 4-6 weeks after the last cycle of neoadjuvant therapy. The first 6 enrolled patients will undergo dose-limiting toxicity (DLT) assessment within 21 days after the first dose of study drug.

The primary endpoint is major pathological response (MPR) rate, defined as the proportion of patients with ≤10% viable tumor cells in the resected specimen. Secondary endpoints include 1-year event-free survival (EFS), pathological complete response (pCR) rate, objective response rate (ORR), disease control rate (DCR), R0 resection rate, 1-year overall survival (OS), time to distant metastasis (TTDM), and safety.

A total of 44 patients will be enrolled across multiple centers in China. An interim analysis will be conducted after 50% of patients are enrolled.

The group in the trial

  • SFRT + Tislelizumab + ChemotherapyTreatment being tested

    Participants receive spatially fractionated radiotherapy (lattice radiation therapy) to the primary lung tumor, with a prescription dose of GTV 20 Gy in 5 fractions and GTV-Lattice 60 Gy in 5 fractions, delivered on Monday, Wednesday, and Friday over one week. Following SFRT, participants receive 2 to 4 cycles (depending on clinical evaluation and per protocol specifications) of tislelizumab 200 mg intravenously on Day 1 of each 21-day cycle (Q3W), combined with platinum-based doublet chemotherapy (carboplatin AUC 5 or cisplatin 75 mg/m², plus pemetrexed 500 mg/m² for non-squamous histology or paclitaxel 175 mg/m² for squamous histology). Definitive radical surgery (lobectomy, bilobectomy, pneumonectomy, or sleeve resection with systematic mediastinal lymph node dissection) is performed 4 to 6 weeks (±7 days) after the last dose of neoadjuvant therapy. The first 6 enrolled patients undergo dose-limiting toxicity (DLT) assessment within 21 days after the first dose of study drugs.

    Treatment: Spatially Fractionated Radiotherapy (SFRT), Tislelizumab, Carboplatin, Cisplatin, Pemetrexed, Paclitaxel, and Radical Lung Resection Surgery

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Prospective, Single-arm, Multicenter Phase II Clinical Study to Evaluate the Efficacy and Safety of Spatially Fractionated Radiotherapy Combined With Tislelizumab and Platinum-based Doublet Chemotherapy as Induction/Conversion Therapy for Potentially Resectable Stage III Non-small Cell Lung Cancer With Bulky Disease.
Plain-language title
Radiation, immunotherapy and chemotherapy before surgery for large lung tumorsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT07775040, who can take part
Record updated
20 August 2026