About this trial
This is an open-label, non-randomized, controlled, single-center, phase II study to compare the efficacy and safety of neoadjuvant PD-L1/PD-1 inhibitor + chemotherapy (carboplatin/cisplatin + etoposide) with chemotherapy (carboplatin/cisplatin + etoposide) alone followed by radical surgery and adjuvant treatment as perioperative therapy in patients with limited-stage SCLC.
Eligibility criteria
Qualifiers
Patients voluntarily participated in this study, signed an informed consent form, and demonstrated good compliance.
They were histologically or cytologically confirmed with limited-stage small-cell lung cancer (TNM stage; T1-3N0-2M0).
The age range was 18 to 75 years, with no gender restriction.
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score: 0-2.
Disqualifiers
Patients who have received anti-tumor treatment for SCLC (including but not limited to chemotherapy and radiation therapy at the site of the lesion).
Patients who have previously used immune checkpoint inhibitors such as PD-1/PD-L1 inhibitors for treatment.
Patients with a history of interstitial lung disease, non-infectious pneumonia, or uncontrollable systemic diseases, including pulmonary fibrosis and acute lung disease.
Patients requiring systemic anti-bacterial, anti-fungal, or anti-viral treatment for severe chronic or active infections, including tuberculosis.
Trial design
Treatments tested in this trial
- Tislelizumab
- Carboplatin injection
- Cisplatin injection
- Etoposide injection
Treatment groups
Locations
Sponsors and collaborators
Beijing Chest Hospital, Capital Medical University
Lead sponsor