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

Zibo Municipal Hospital

Status and phase: Enrolling; Phase 2

Conditions: Hypofractionated Radiotherapy; Chemotherapy; Tislelizumab; NSCLC

Treatments: Drug: SBRT combined with Tislelizumab followed by Tislelizumab

Study type: Interventional

Funder types: Other

Identifiers

NCT07198217

2021-Ethical Review -01

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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. 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

1. Patients with uncontrolled autoimmune diseases;
2. 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;
3. 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;
4. Patients with known allergies or contraindications to the study drug or its excipients;
5. Pregnant or lactating female patients, or female patients of childbearing potential with a positive baseline pregnancy test;
6. 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;
7. Patients whose comorbidities or other conditions may affect compliance with the protocol or are deemed unsuitable for participation in this study by the investigator.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

treatment arm

Experimental group

Treatment:

Drug: SBRT combined with Tislelizumab followed by Tislelizumab