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Neoadjuvant SF-SBRT Plus Toripalimab and Chemotherapy in Resectable Stage II-III NSCLC.

NCT07608159 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 201

Last updated 2026-05-29

No results posted yet for this study

Summary

This is an open-label, randomized, controlled, multicenter phase III clinical trial designed to evaluate the efficacy and safety of spatially fractionated stereotactic body radiotherapy (SF-SBRT) combined with toripalimab and platinum-based chemotherapy versus toripalimab combined with platinum-based chemotherapy in patients with resectable or potentially resectable stage II-III non-small cell lung cancer (NSCLC). Eligible participants will be randomized 2:1 to receive either neoadjuvant SF-SBRT followed by toripalimab and platinum-based chemotherapy for two cycles, or toripalimab and platinum-based chemotherapy for three cycles. Randomization will be stratified by disease stage and histological subtype. Surgery is planned 4-6 weeks after completion of neoadjuvant treatment, and postoperative adjuvant therapy will be determined by the investigator. The primary endpoint is the 2-year event-free survival rate. Secondary endpoints include pathological complete response rate, major pathological response rate, objective response rate, R0 resection rate, event-free survival, overall survival, and safety. Adverse events will be assessed according to NCI CTCAE version 5.0 or later.

Conditions

  • Non Small Cell Lung Cancer
  • Stereotactic Body Radiotherapy
  • Neoadjuvant Chemoimmunotherapy
  • Surgery

Interventions

RADIATION

Stereotactic body radiotherapy (SBRT)

spatially fractionated stereotactic body radiotherapy

DRUG

neoadjuvant immunotherapy

Toripalimab IV (dose 240mg) Q3W

DRUG

Neoadjuvant Chemotherapy

Squamous cell carcinoma: Paclitaxel (175mg/m²) or Docetaxel (60-75 mg/m²) or Nab-paclitaxel (260mg/m²) plus Carboplatin (AUC=5)/Cisplatin (75 mg/m²) (to be determined by researchers); Non-squamous cell carcinoma: Pemetrexed (500mg/m²) plus Carboplatin/Cisplatin (to be determined by researchers)

Sponsors & Collaborators

  • Shanghai Pulmonary Hospital, Shanghai, China

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2029-05-31
Completion
2030-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07608159 on ClinicalTrials.gov