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Trial Title:
Tislelizumab Combined With Chemotherapy and Thoracic Radiotherapy in ES-SCLC
NCT ID:
NCT06536868
Condition:
Extensive-stage Small-cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Carboplatin
Etoposide
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Tislelizumab infusion will be administered for 2 years (200mg, day1, Q3W).
Arm group label:
ICI+EC/EP+TRT
Intervention type:
Drug
Intervention name:
Etoposide
Description:
Etoposide intravenous infusion will be administered during the induction phase (100mg/㎡,
day1-3 Q3W for 4 cycles).
Arm group label:
ICI+EC/EP+TRT
Intervention type:
Drug
Intervention name:
Carboplatin or Cisplatin
Description:
Carboplatin or Cisplatin intravenous infusion will be administered during the induction
phase (Carboplatin AUC5, Q3W for 4 cycles; Cisplatin 75mg/㎡, Q3W for 4 cycles).
Arm group label:
ICI+EC/EP+TRT
Intervention type:
Radiation
Intervention name:
Thoracic radiotherapy
Description:
IMRT 30-45Gy/10-15f
Arm group label:
ICI+EC/EP+TRT
Summary:
This study is a single arm, open, multicenter phase II study. The main purpose of this
study was to evaluate preliminary efficacy and safety of Tislelizumab combined with
thoracic radiotherapy as first line therapy for Extensive stage small cell lung cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients aged between 18 to 80 years old (inclusive of 18th and 80th birthdays),
male or female, at the time of signing the informed consent form;
- Confirmed small cell lung cancer of extensive stage by histology or cytology;
- At least one measurable lesion by imaging studies (according to RECIST 1.1) with a
long diameter of ≥10 mm as examined by spiral CT or MRI;
- Within 3 days prior to treatment, an ECOG score of 0 to 1;
- No prior antitumor treatment for extensive stage disease (if the patient has
previously received chemotherapy and/or radiotherapy in the limited stage of SCLC,
the treatment intent must have been curative, and there must be at least a 6-month
treatment-free interval between the end of chemotherapy, radiotherapy, or
chemoradiotherapy and the diagnosis of extensive stage SCLC);
- Expected life span of ≥3 months;
- Good function of vital organs;
- The subject voluntarily joins this study, signs the informed consent form, has good
compliance, and cooperates with follow-up.
Exclusion Criteria:
- Concurrent severe respiratory diseases: such as pulmonary fibrosis;
- Presence of psychiatric disorders, hematologic diseases, autoimmune diseases, and
severe primary diseases of the heart, brain, liver, or kidneys;
- Uncontrolled active infections;
- Known or suspected allergies to the study medication and its excipients;
- Female patients who are pregnant or breastfeeding, or women of childbearing
potential with a positive baseline pregnancy test;
- Prior use of antitumor treatment targeting the PD-(L)1 pathway.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Jincheng General Hospital
Address:
City:
Jincheng
Zip:
048000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xueqin Li, Dr.
Phone:
+86 356 3661360
Facility:
Name:
Jinzhong third people's hospital
Address:
City:
Jinzhong
Zip:
032000
Country:
China
Status:
Recruiting
Contact:
Last name:
Qian Wu, Dr.
Phone:
+86 354 3532157
Facility:
Name:
Second Hospital of Shanxi Medical University
Address:
City:
Taiyuan
Zip:
030000
Country:
China
Status:
Recruiting
Contact:
Last name:
Gang Jin, Dr.
Phone:
+86 351 3365422
Facility:
Name:
Shanxi Bethune Hospital
Address:
City:
Taiyuan
Zip:
030000
Country:
China
Status:
Recruiting
Contact:
Last name:
Huijing Feng, Dr.
Phone:
+86 351 8368114
Facility:
Name:
Shanxi Hospital of Traditional Chinese Medicine
Address:
City:
Taiyuan
Zip:
030000
Country:
China
Status:
Recruiting
Contact:
Last name:
Jinyang Bai, Dr.
Phone:
+86 351 303009
Facility:
Name:
TISCO General Hospital
Address:
City:
Taiyuan
Zip:
030000
Country:
China
Status:
Recruiting
Contact:
Last name:
Weihua Jia, Dr.
Phone:
+86 351 3012448
Start date:
August 1, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Second Hospital of Shanxi Medical University
Agency class:
Other
Source:
Second Hospital of Shanxi Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06536868
