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NCT Number: NCT07085182

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Zibo Municipal Hospital

Zibo, Shandong, 250000, China

Location status: Recruiting

Location contact

Qiang Wang

CONTACT

[email protected]

18953316759

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • Patients who have not received prior systemic therapy;

Exclusion criteria

  • Patients with uncontrolled autoimmune diseases;
  • 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.;
  • Patients known to carry driver gene mutations such as EGFR mutation, ALK translocation, BRAF, ROS1, RET, MET, etc.;
  • 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;
  • 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.

Treatment and study plan

SBRT combined with Tislelizumab followed by Tislelizumab

Drug

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

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: Up to approximately 30 months

    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

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Up to approximately 30 months

    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.

  2. Overall Survival (OS)

    Time frame: Up to ~60 months

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

  3. Disease Control Rate (DCR)

    Time frame: Up to ~24 months

    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.

  4. Adverse events

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

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Qiang Wang

CONTACT

[email protected]

+8618953316759

Sponsors and collaborators

Lead sponsor

Zibo Municipal Hospital

Other

Registry information

Official study title

Tislelizumab Combined With sCRT in Stage IIIB/C-IV Non-Squamous Non-Small Cell Lung Cancer

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Jul 25, 2025
Registry last updated
Jul 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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