Tislelizumab Combined With Chemotherapy and Thoracic Radiotherapy in ES-SCLC
- Conditions
- Extensive-stage Small-cell Lung Cancer
- Interventions
- Registration Number
- NCT06536868
- Lead Sponsor
- Second Hospital of Shanxi Medical University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ICI+EC/EP+TRT Tislelizumab Drug: Tislelizumab Drug: Carboplatin Drug: Etoposide Radiation: Radiation therapy Drug: Cisplatin ICI+EC/EP+TRT Carboplatin or Cisplatin Drug: Tislelizumab Drug: Carboplatin Drug: Etoposide Radiation: Radiation therapy Drug: Cisplatin ICI+EC/EP+TRT Etoposide Drug: Tislelizumab Drug: Carboplatin Drug: Etoposide Radiation: Radiation therapy Drug: Cisplatin ICI+EC/EP+TRT Thoracic radiotherapy Drug: Tislelizumab Drug: Carboplatin Drug: Etoposide Radiation: Radiation therapy Drug: Cisplatin
- Primary Outcome Measures
Name Time Method Progression-free Survival (PFS) Up to 2 years From the date of enrollment to the date of disease progression
- Secondary Outcome Measures
Name Time Method Overall Survival （OS） Up to 2 years From the date of enrollment until death by any cause or last follow-up
Objective Response Rate (ORR) Up to 2 years ORR as assessed by the Investigator according to RECIST v1.1
Adverse events Up to 2 years Treatment-related adverse events according to CTCAE 5.0.
Disease Control Rate (DCR) Up to 2 years DCR as assessed by the Investigator according to RECIST v1.1
Trial Locations
- Locations (6)
Jinzhong third people's hospital
🇨🇳Jinzhong, Shanxi, China
Jincheng General Hospital
🇨🇳Jincheng, Shanxi, China
Second Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
Shanxi Bethune Hospital
🇨🇳Taiyuan, Shanxi, China
Shanxi Hospital of Traditional Chinese Medicine
🇨🇳Taiyuan, Shanxi, China
TISCO General Hospital
🇨🇳Taiyuan, Shanxi, China