Real World Study of Platinum Containing Dual Drug Chemotherapy Followed by Large Fractionated Radiotherapy Combined withTislelizumab in Stage IIIB/C-IV Non-small Cell Lung Cancer Patient

NCT ID: NCT07198217

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-25
• Study Completion Date: 2027-10-10

Brief Summary

In clinical practice, some patients cannot tolerate concurrent chemoradiotherapy. The purpose of this study is to observe the efficacy and safety of 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

Group Type: EXPERIMENTAL

SBRT combined with Tislelizumab followed by Tislelizumab

Intervention Type: DRUG

The enrolled population consists of patients with stage IIIB/C-IV non-small cell lung cancer who are driver gene negative or unknown, as well as those with driver gene positive targeted drug resistance. The patients reaching SD, PR, or CR after 4 cycles of platinum based dual drug chemotherapy. The patient will receive SBRT radiotherapy combined with Tislelizumab treatment, followed by Tislelizumab maintenance therapy.

Interventions

SBRT combined with Tislelizumab followed by Tislelizumab

The enrolled population consists of patients with stage IIIB/C-IV non-small cell lung cancer who are driver gene negative or unknown, as well as those with driver gene positive targeted drug resistance. The patients reaching SD, PR, or CR after 4 cycles of platinum based dual drug chemotherapy. The patient will receive SBRT radiotherapy combined with Tislelizumab treatment, followed by Tislelizumab maintenance therapy.

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. Tumor histology or hematology confirms no EGFR mutations and no mutations or positive driver genes for ALK, BRAF, ROS1, RET, MET, etc or Targeted drug therapy leads to drug resistance progression

Exclusion Criteria

1. Patients with uncontrolled autoimmune diseases;

2. Patients who have experienced autoimmune reactions within the past 6 months and whose conditions have not improved or are unstable after corresponding treatments, such as pneumonia, thyroiditis, myocarditis, etc. that have not stabilized after treatment;

3. Patients who have previously received systemic chemotherapy, or adjuvant or neoadjuvant therapy, and the time from the last treatment to recurrence is less than 3 months;

4. Patients with known allergies or contraindications to the study drug or its excipients;

5. Pregnant or lactating female patients, or female patients of childbearing potential with a positive baseline pregnancy test;

6. 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;

7. 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

Role: backup

18953316759@163.com

Other Identifiers

2021-Ethical Review -01

Identifier Type: -

Identifier Source: org_study_id