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Recruiting Phase 2

Tislelizumab Combined With sCRT in Stage IIIB/C-IV Non-Squamous Non-Small Cell Lung Cancer:A Prospective, Single-Arm, Phase II Study

NCT07085182 · tracked via the Priya Life Science China tracker
Sponsor
Zibo Municipal Hospital
Phase
Phase 2
Started
2024-01-13
Last updated
2025-07-25

Condition(s) studied

NSCLCTislelizumabChemotherapyHypofractionated Radiotherapy

Investigational drug(s) / intervention(s)

SBRT combined with Tislelizumab followed by TislelizumabAll SBRT trials (11) →All Tislelizumab followed by Tislelizumab trials (2) →

SBRT combined with Tislelizumab followed by Tislelizumab: SBRT:3-10Gy/F, once daily, 5 times a week; Tislelizumab(200mg,iv,q3w):Tislelizumab was added after five sessions of SBRT radiotherapy.

Study summary

In clinical practice, some patients cannot tolerate concurrent chemoradiotherapy. The purpose of this study is to observe the efficacy and safety of Tislelizumab combined with platinum-based doublet chemotherapy followed by hypofractionated radiotherapy and Tislelizumab in patients with stage IIIB/C-IV non-squamous non-small cell lung cancer. This study aims to provide more treatment options for patients with locally advanced non-small cell lung cancer.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Age 18-75 years old, gender is not limited; 2. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. 3. Patients with stage IIIB/C-IV non-squamous non-small cell lung cancer confirmed by cytology or histology; 4. Patients who have not received prior systemic therapy; Exclusion Criteria: 1. Patients with uncontrolled autoimmune diseases; 2. Patients who have had autoimmune reactions in the past 6 months and have not improved or are unstable despite appropriate treatment, such as untreated or unstable pneumonia, thyroiditis, myocarditis, etc.; 3. Patients known to carry driver gene mutations such as EGFR mutation, ALK translocation, BRAF, ROS1, RET, MET, etc.; 4. Patients who have received prior systemic therapy, or those who have received adjuvant or neoadjuvant therapy with a recurrence time of less than 3 months from the last treatment; 5. Patients with known allergies or contraindications to the study drug or its excipients; 6. Pregnant or lactating female patients, or female patients of childbearing potential with a positive baseline pregnancy test; 7. Female patients of childbearing potential or male patients with reproductive plans who are unwilling to use effective contraception during the entire trial period and for 6 months after the end of the trial; 8. Patients whose comorbidities or other conditions may affect compliance with the protocol or are deemed unsuitable for participation in this study by the investigator.

Primary outcome measure(s)

  • Progression-Free Survival (PFS) — Up to approximately 30 months
    PFS is defined as the time from the first dose until the first documentation of progression or death from any cause, whichever occurs first, as assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Trial sites (1)

FacilityCityRegionStatus
Zibo Municipal Hospital Zibo Shandong Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07085182 on ClinicalTrials.gov ↗ ← All trials in China