Tislelizumab Combined With Chemotherapy and Thoracic Radiotherapy in ES-SCLC

NCT06536868 | Recruiting Phase 2 DMC

• 1 other identifier: [2024] YX No. 274
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 6

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.

Conditions

Extensive-stage Small-cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  From the date of enrollment to the date of disease progression

  Up to 2 years

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  Up to 2 years

• Disease Control Rate (DCR)

  Up to 2 years

• Overall Survival （OS）

  Up to 2 years

• Adverse events

  Up to 2 years

Study Arms (1)

ICI+EC/EP+TRT

EXPERIMENTAL

Drug: Tislelizumab Drug: Carboplatin Drug: Etoposide Radiation: Radiation therapy Drug: Cisplatin

Drug: Tislelizumab; Drug: Etoposide; Drug: Carboplatin or Cisplatin; Radiation: Thoracic radiotherapy

Interventions

Tislelizumab DRUG

Tislelizumab infusion will be administered for 2 years (200mg, day1, Q3W).

ICI+EC/EP+TRT

Etoposide DRUG

Etoposide intravenous infusion will be administered during the induction phase (100mg/㎡, day1-3 Q3W for 4 cycles).

ICI+EC/EP+TRT

Carboplatin or Cisplatin DRUG

Carboplatin or Cisplatin intravenous infusion will be administered during the induction phase (Carboplatin AUC5, Q3W for 4 cycles; Cisplatin 75mg/㎡, Q3W for 4 cycles).

ICI+EC/EP+TRT

Thoracic radiotherapy RADIATION

IMRT 30-45Gy/10-15f

ICI+EC/EP+TRT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Hospital of Shanxi Medical University: lead

Study Sites (6)

Jincheng General Hospital

Jincheng, Shanxi, 048000, China

RECRUITING

Jinzhong third people's hospital

Jinzhong, Shanxi, 032000, China

RECRUITING

Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030000, China

RECRUITING

Shanxi Bethune Hospital

Taiyuan, Shanxi, 030000, China

RECRUITING

Shanxi Hospital of Traditional Chinese Medicine

Taiyuan, Shanxi, 030000, China

RECRUITING

TISCO General Hospital

Taiyuan, Shanxi, 030000, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

tislelizumab; Etoposide; Carboplatin; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Coordination Complexes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Gang Jin, Dr.

  Second Hospital of Shanxi Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gang Jin, Dr.

CONTACT

+86 351 3365422; jingang2018@sina.com

Chen Zhang

CONTACT

+86 351 3365422; jingang2018@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: July 31, 2024
• First Posted: August 5, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)