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

Recruiting now · Phase 2

Conditions studied: NSCLC, Tislelizumab, Chemotherapy, Hypofractionated Radiotherapy

In brief

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.

Key facts

Study ID

NCT07085182

Run by

Zibo Municipal Hospital

People needed

20

Starts

2024-01-13

Expected to finish

2028-12-10

Last updated by the study team

2025-07-25

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 18-75 years old, gender is not limited;
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Patients with stage IIIB/C-IV non-squamous non-small cell lung cancer confirmed by cytology or histology;
• Patients who have not received prior systemic therapy;

You may not qualify if…

• Patients with uncontrolled autoimmune diseases;
• 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.;
• Patients known to carry driver gene mutations such as EGFR mutation, ALK translocation, BRAF, ROS1, RET, MET, etc.;
• 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;
• Patients with known allergies or contraindications to the study drug or its excipients;
• Pregnant or lactating female patients, or female patients of childbearing potential with a positive baseline pregnancy test;
• 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;
• Patients whose comorbidities or other conditions may affect compliance with the protocol or are deemed unsuitable for participation in this study by the investigator.

Where it is running

• Zibo Municipal Hospital — Zibo, Shandong, China (enrolling)

Full record on ClinicalTrials.gov

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