Combining Tislelizumab with chemotherapy before surgery for advanced lung cancer

Efficacy and Safety of Tislelizumab With Platinum Doublet Chemotherapy as Neoadjuvant Therapy for Participants With Initially Unresectable Stage III Non-small Cell Lung Cancer: A Single-arm, Phase II Trial

This study is testing if combining the immunotherapy drug Tislelizumab with chemotherapy before surgery can help people with advanced lung cancer have better treatment results.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Beijing Tsinghua Chang Gung Hospital (other)
• Drugs / interventions: immunotherapy, prednisone, Tislelizumab
• Locations: 1 site (Beijing, Beijing)
• Trial ID: NCT05611879 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of Tislelizumab, an immunotherapy drug, combined with chemotherapy in patients with unresectable stage III non-small cell lung cancer (NSCLC). Participants will receive this combination treatment before undergoing surgery to assess how well it works in shrinking tumors. The study aims to determine if this neoadjuvant approach can improve outcomes for patients who cannot initially have surgery due to the extent of their cancer. The trial will monitor various health parameters to ensure patient safety and treatment efficacy.

Who should consider this trial

Good fit: Ideal candidates for this study are adults with unresectable stage III non-small cell lung cancer who have a good performance status and meet specific health criteria.

Not a fit: Patients who have previously received systemic anti-tumor therapy for NSCLC or have certain active infections or autoimmune diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new treatment option that improves surgical outcomes and overall survival for patients with advanced lung cancer.

How similar studies have performed: Other studies have shown promising results with similar neoadjuvant immunotherapy approaches in lung cancer, indicating potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

* Written informed consent provided.
* Unresectable stage III non-small cell lung cancer confirmed by histopathology or cytology.
* ECOG score is 0 or 1.
* Adequate hematological function, liver function and renal function.

Exclusion Criteria:

* Previously received systemic anti-tumor therapy for non-small cell lung cancer.
* history or current (non-infectious) pneumonia/interstitial pneumonia requiring steroid treatment.
* History or active pulmonary tuberculosis.
* Active infections that require systemic treatment.
* History or suspected autoimmune disease or immune deficiency who, in the judgment of the investigator, cannot tolerate immunotherapy.
* Untreated active Hepatitis B.
* Has a known history of human immunodeficiency virus (HIV) infection (HIV 1/2 antibody positive).
* Grade 3 or above peripheral neuropathy.
* Severe allergic history to pemetrexed, paclitaxel, albumin-bound paclitaxel, carboplatin or other preventive drugs.
* Underlying severe or uncontrolled disease.
* Malignant tumors other than NSCLC within 5 years.
* Any medical condition requiring systemic treatment with corticosteroids (prednisone or equivalent at a dose of \>10mg/ day) or other immunosuppressive agents within 14 days prior to treatment.

Where this trial is running

Beijing, Beijing

• Beijing Tsinghua Chang Gung Hospital — Beijing, Beijing, China (RECRUITING)

Study contacts

• Principal investigator: Donghong Chen, Dr. — Beijing Tsinghua Chang Gung Hospital
• Study coordinator: Fan Yang, Dr.

Conditions: NSCLC, Stage III