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NCT Number: 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

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.

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

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;
  • 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.

Treatment and study plan

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.

Primary outcomes

  1. One-year PFS rate

    Time frame: Up to approximately 24 months

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

Secondary 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

  2. Objective Response Rate (ORR)

    Time frame: Up to approximately 24 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.

  3. Overall survival (OS)

    Time frame: Up to ~48 months

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

  4. 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.

  5. 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

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Sep 30, 2025
Registry last updated
Sep 30, 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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