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

Launched by ZIBO MUNICIPAL HOSPITAL · Jul 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for people with advanced non-squamous non-small cell lung cancer, a type of lung cancer that has spread beyond the lungs (stage IIIB, IIIC, or IV). The study is testing how well a medicine called Tislelizumab works when combined with chemotherapy (using platinum-based drugs) followed by a special type of focused radiation therapy. The goal is to see if this combination is safe and effective, especially for patients who may not be able to handle the usual combined chemotherapy and radiation treatments.

To join this study, participants need to be between 18 and 75 years old, have a confirmed diagnosis of this type and stage of lung cancer, and have not received any previous cancer treatment. They should also be well enough to take part, as measured by a standard health rating. People with certain autoimmune diseases, specific genetic mutations in their cancer, or who are pregnant or planning to become pregnant are not eligible. If selected, participants will receive the study treatment and be closely monitored to understand how well it works and what side effects may occur. This trial aims to offer another treatment option that might help improve outcomes for people with advanced lung cancer.

Gender

ALL

Eligibility criteria

• 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.