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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZibo Municipal Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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 groups

20 Participants
are divided into 1 treatment group
Group A: treatment armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

One-year PFS rate

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

Time frame
Up to approximately 24 months

Secondary 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
2

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 24 months
3

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 ~48 months
4

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

Other outcomes

Sponsors and contacts

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