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Recruiting NCT06536868

Tislelizumab Combined With Chemotherapy and Thoracic Radiotherapy in ES-SCLC

Phase II Interventional Extensive-stage Small-cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tislelizumab, Etoposide, Carboplatin or Cisplatin, Thoracic radiotherapy.
Who it may be relevant to
Registry conditions: Extensive-stage Small-cell Lung Cancer. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Progression-free Survival (PFS) [Time frame: Up to 2 years]
Secondary outcome measures (4)
  • Objective Response Rate (ORR) [Time frame: Up to 2 years]
  • Disease Control Rate (DCR) [Time frame: Up to 2 years]
  • Overall Survival （OS） [Time frame: Up to 2 years]
  • Adverse events [Time frame: Up to 2 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 6 centers
  • Jincheng General Hospital — Jincheng
  • Jinzhong third people's hospital — Jinzhong
  • Second Hospital of Shanxi Medical University — Taiyuan
  • Shanxi Bethune Hospital — Taiyuan
  • Shanxi Hospital of Traditional Chinese Medicine — Taiyuan
  • TISCO General Hospital — Taiyuan

Identifiers

NCT: NCT06536868 · [2024] YX No. 274

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗