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

NCT ID: NCT07085182

Last Updated: 2025-07-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-13
• Study Completion Date: 2028-12-10

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

treatment arm

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.

Group Type: EXPERIMENTAL

SBRT combined with Tislelizumab followed by Tislelizumab

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zibo Municipal Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zibo Municipal Hospital

Zibo, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Qiang Wang

Role: CONTACT

18953316759@163.com

+8618953316759

Facility Contacts

Qiang Wang

Role: primary

18953316759@163.com

18953316759

Other Identifiers

2024-Ethical Review -01

Identifier Type: -

Identifier Source: org_study_id