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

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 testing if combining a new drug called Tislelizumab with chemotherapy and radiation can help people with extensive-stage small-cell lung cancer feel better and improve their health.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Second Hospital of Shanxi Medical University (Academic / other)
• Drugs / interventions: chemotherapy, Tislelizumab
• Locations: 6 sites (Jincheng, Shanxi and 5 other locations)
• Trial ID: NCT06536868 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with confirmed extensive-stage small-cell lung cancer and at least one measurable lesion.

Not a fit: Patients with prior antitumor treatment for extensive-stage disease or those with a poor ECOG performance status may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a new effective option for patients suffering from extensive-stage small-cell lung cancer.

How similar studies have performed: While this approach is being evaluated in this specific context, similar combinations of immunotherapy and chemotherapy have shown promise in other studies.

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.

Where this trial is running

Jincheng, Shanxi and 5 other locations

• 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.

Conditions Extensive-stage Small-cell Lung Cancer