Clinical trial NCT06536868: Tislelizumab Combined With Chemotherapy and Thoracic Radiotherapy in ES-SCLC
Official title: Tislelizumab Plus Chemotherapy and Concurrent Thoracic Radiotherapy as First-line Therapy for Extensive-stage Small-Cell Lung Cancer (ES-SCLC): an Multicenter, Single Arm Prospective Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Extensive-stage Small-cell Lung Cancer
Lead sponsor: Second Hospital of Shanxi Medical University
Sponsor class: OTHER
First posted: 2024-08-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Progression-free Survival (PFS)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 2 years
measure: Disease Control Rate (DCR)
timeFrame: Up to 2 years
measure: Overall Survival （OS）
timeFrame: Up to 2 years
measure: Adverse events
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Jincheng
country: China
facility: Jincheng General Hospital
state: Shanxi
city: Jinzhong
country: China
facility: Jinzhong third people's hospital
state: Shanxi
city: Taiyuan
country: China
facility: Second Hospital of Shanxi Medical University
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
state: Shanxi
city: Taiyuan
country: China
facility: Shanxi Hospital of Traditional Chinese Medicine
state: Shanxi
city: Taiyuan
country: China
facility: TISCO General Hospital
state: Shanxi
Study officials:
affiliation: Second Hospital of Shanxi Medical University
name: Gang Jin, Dr.
role: PRINCIPAL_INVESTIGATOR
References: