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Recruiting NCT07198217

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

Phase II Interventional NSCLC Tislelizumab Chemotherapy Hypofractionated Radiotherapy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SBRT combined with Tislelizumab followed by Tislelizumab.
Who it may be relevant to
Registry conditions: NSCLC, Tislelizumab, Chemotherapy, Hypofractionated Radiotherapy. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Drug 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.

Primary outcome measures

  • One-year PFS rate [Time frame: Up to approximately 24 months]
Secondary outcome measures (5)
  • Progression-Free Survival (PFS) [Time frame: Up to approximately 30 months]
  • Objective Response Rate (ORR) [Time frame: Up to approximately 24 months]
  • Overall survival (OS) [Time frame: Up to ~48 months]
  • Disease Control Rate (DCR) [Time frame: Up to ~24 months]
  • Adverse events [Time frame: Through study completion, an average of 2 year]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Zibo Municipal Hospital — Zibo

Identifiers

NCT: NCT07198217 · 2021-Ethical Review -01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗