Tislelizumab Combined With Chemotherapy and Thoracic Radiotherapy in ES-SCLC

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

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.

Study Overview

• Status: Recruiting
• Conditions: Extensive-stage Small-cell Lung Cancer
• Intervention / Treatment: Drug: Tislelizumab; Drug: Etoposide; Drug: Carboplatin or Cisplatin; Radiation: Thoracic radiotherapy

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Gang Jin, Dr.; Phone Number: +86 351 3365422; Email: jingang2018@sina.com
• Study Contact Backup: Name: Chen Zhang; Phone Number: +86 351 3365422; Email: jingang2018@sina.com

Study Locations

• China
  • Shanxi
    • Jincheng, Shanxi, China, 048000
      • Recruiting
      • Jincheng General Hospital
      • Contact: Xueqin Li, Dr.; Phone Number: +86 356 3661360
    • Jinzhong, Shanxi, China, 032000
      • Recruiting
      • Jinzhong third people's hospital
      • Contact: Qian Wu, Dr.; Phone Number: +86 354 3532157
    • Taiyuan, Shanxi, China, 030000
      • Recruiting
      • Second Hospital of Shanxi Medical University
      • Contact: Gang Jin, Dr.; Phone Number: +86 351 3365422
    • Taiyuan, Shanxi, China, 030000
      • Recruiting
      • Shanxi Bethune Hospital
      • Contact: Huijing Feng, Dr.; Phone Number: +86 351 8368114
    • Taiyuan, Shanxi, China, 030000
      • Recruiting
      • Shanxi Hospital of Traditional Chinese Medicine
      • Contact: Jinyang Bai, Dr.; Phone Number: +86 351 303009
    • Taiyuan, Shanxi, China, 030000
      • Recruiting
      • TISCO General Hospital
      • Contact: Weihua Jia, Dr.; Phone Number: +86 351 3012448

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ICI+EC/EP+TRT; Drug: Tislelizumab Drug: Carboplatin Drug: Etoposide Radiation: Radiation therapy Drug: Cisplatin

Drug: Tislelizumab; Tislelizumab infusion will be administered for 2 years (200mg, day1, Q3W).; Drug: Etoposide; Etoposide intravenous infusion will be administered during the induction phase (100mg/㎡, day1-3 Q3W for 4 cycles).; Drug: Carboplatin or Cisplatin; Carboplatin or Cisplatin intravenous infusion will be administered during the induction phase (Carboplatin AUC5, Q3W for 4 cycles; Cisplatin 75mg/㎡, Q3W for 4 cycles).; Radiation: Thoracic radiotherapy; IMRT 30-45Gy/10-15f

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	From the date of enrollment to the date of disease progression	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate (ORR)	ORR as assessed by the Investigator according to RECIST v1.1	Up to 2 years
Disease Control Rate (DCR)	DCR as assessed by the Investigator according to RECIST v1.1	Up to 2 years
Overall Survival （OS）	From the date of enrollment until death by any cause or last follow-up	Up to 2 years
Adverse events	Treatment-related adverse events according to CTCAE 5.0.	Up to 2 years

Collaborators and Investigators

• Sponsor: Second Hospital of Shanxi Medical University
• Investigators: Principal Investigator: Gang Jin, Dr., Second Hospital of Shanxi Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 31, 2024
• First Submitted That Met QC Criteria: July 31, 2024
• First Posted (Actual): August 5, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Small Cell Lung Carcinoma; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Carbohydrates; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glucosides; Glycosides; Inorganic Chemicals; Chlorine Compounds; Nitrogen Compounds; Coordination Complexes; Platinum Compounds; Etoposide; Carboplatin; Cisplatin; tislelizumab
• Other Study ID Numbers: [2024] YX No. 274

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No