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

NCT07085182 | Recruiting Phase 2 DMC

• 1 other identifier: 2024-Ethical Review -01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

NSCLC; Tislelizumab; Chemotherapy; Hypofractionated Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS)

  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

  Up to approximately 30 months

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  Up to approximately 30 months

• Overall Survival (OS)

  Up to ~60 months

• Disease Control Rate (DCR)

  Up to ~24 months

• Adverse events

  Through study completion, an average of 2 year

Study Arms (1)

treatment arm

EXPERIMENTAL

For patients with driver gene-negative stage IIIB/C-IV non-squamous non-small cell lung cancer, after 4 cycles of Tislelizumab combined with platinum-based doublet chemotherapy, if the tumor efficacy evaluation reaches SD, PR, or CR, radiotherapy will be administered to the tumor lesions combined withTislelizumab. After that, Tislelizumab maintenance therapy will be continued.

Drug: SBRT combined with Tislelizumab followed by Tislelizumab

Interventions

SBRT combined with Tislelizumab followed by Tislelizumab DRUG

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

treatment arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Zibo Municipal Hospital: lead

Study Sites (1)

Zibo Municipal Hospital

Zibo, Shandong, 250000, China

RECRUITING

Central Study Contacts

Qiang Wang

CONTACT

+8618953316759; 18953316759@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 25, 2025
• Study Start: January 13, 2024
• Primary Completion (Estimated): December 10, 2027
• Study Completion (Estimated): December 10, 2028
• Last Updated: July 25, 2025

Record last verified: 2025-07

Locations

CN (1)