Combining Tislelizumab with chemotherapy and radiotherapy for extensive-stage small-cell lung cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-arm, open-label, multicenter phase II study aimed at evaluating the preliminary efficacy and safety of Tislelizumab when combined with thoracic radiotherapy as a first-line treatment for extensive-stage small-cell lung cancer. Participants will receive Tislelizumab along with either Etoposide and Carboplatin or Cisplatin, alongside thoracic radiotherapy. The study will assess the treatment's effectiveness based on measurable lesions and overall patient health. The goal is to provide a new therapeutic option for patients with this aggressive form of lung cancer.

Why it matters

Who can join: the full rules

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.

Where it's running

• Jincheng General Hospital
  Jincheng, Shanxi, China Recruiting
• Jinzhong third people's hospital
  Jinzhong, Shanxi, China Recruiting
• Second Hospital of Shanxi Medical University
  Taiyuan, Shanxi, China Recruiting
• Shanxi Bethune Hospital
  Taiyuan, Shanxi, China Recruiting
• Shanxi Hospital of Traditional Chinese Medicine
  Taiyuan, Shanxi, China Recruiting
• TISCO General Hospital
  Taiyuan, Shanxi, China Recruiting

Study contacts

• Principal investigator: Gang Jin, Dr. — Second Hospital of Shanxi Medical University
• Study coordinator: Gang Jin, Dr.
• Email: jingang2018@sina.com
• Phone: +86 351 3365422

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using T-cell receptor patterns to predict response to first-line tislelizumab plus chemotherapy in extensive-stage small-cell lung cancer

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• SYS6010 plus Enlonstobart for recurrent or metastatic nasopharyngeal cancer in patients who have not had prior systemic therapy

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.