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RecruitingNCT07085182Updated Jul 25, 2025

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

A Phase 2 interventional study of SBRT combined with Tislelizumab followed by Tislelizumab in NSCLC, Tislelizumab and Chemotherapy, sponsored by Zibo Municipal Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-07-25.

Sponsored by Zibo Municipal Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 6 months after the study started (first participant enrolled Jan 2024, registered Jul 2025).
  • Started Jan 2024; still recruiting 2 years 8 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • NSCLC
  • Tislelizumab
  • Chemotherapy
  • Hypofractionated Radiotherapy
03

In context

Lead sponsor

Zibo Municipal Hospital is the lead sponsor of 2 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    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.

    Drug: SBRT combined with Tislelizumab followed by Tislelizumab

Interventions

  • DrugSBRT 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.

06

What researchers measure

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

    Time frame: Up to approximately 30 months

Secondary outcomes

  1. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with complete response (CR) or partial response (PR), as assessed by the investigator using RECIST v1.1.

    Time frame: Up to approximately 30 months

  2. Overall Survival (OS)

    OS is defined as the time from first dose until the date of death due to any cause

    Time frame: Up to ~60 months

  3. Disease Control Rate (DCR)

    DCR is defined as the percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD), as assessed by the investigator using RECIST v1.1.

    Time frame: Up to ~24 months

  4. Adverse events

    The incidence and severity of AEs will be determined according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI CTCAE v5.0).

    Time frame: Through study completion, an average of 2 year

07

Study locations

1 of 1 sites recruiting
  • Zibo Municipal Hospital
    Zibo, Shandong 250000, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07085182
Lead sponsor
Zibo Municipal Hospital
Responsible party
Sponsor
First posted
Jul 25, 2025
Start date
Jan 13, 2024
Primary completion
Dec 10, 2027 (estimated)
Completion
Dec 10, 2028 (estimated)
Last update
Jul 25, 2025

Study contacts

Qiang Wang
Contact
18953316759@163.com
+8618953316759

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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