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

NCT07198217 | Recruiting Phase 2

• 1 other identifier: 2021-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 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)

• One-year PFS rate

  The proportion of patients who survived for more than one year after treatment without disease progression

  Up to approximately 24 months

Secondary Outcomes (5)

• Progression-Free Survival (PFS)

  Up to approximately 30 months

• Objective Response Rate (ORR)

  Up to approximately 24 months

• Overall survival (OS)

  Up to ~48 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

Drug: SBRT combined with Tislelizumab followed by Tislelizumab

Interventions

SBRT combined with Tislelizumab followed by Tislelizumab 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.

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;
• 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

You may not qualify if:

• Patients with uncontrolled autoimmune diseases;
• 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;
• 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;
• 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: September 22, 2025
• First Posted: September 30, 2025
• Study Start: May 25, 2021
• Primary Completion: September 28, 2025
• Study Completion (Estimated): October 10, 2027
• Last Updated: September 30, 2025

Record last verified: 2025-09

Locations

CN (1)