PD-L1/PD-1 Inhibitors Plus Chemotherapy Versus Chemotherapy Alone for the Neoadjuvant Treatment of Limited-stage SCLC

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Chest Hospital, Capital Medical University

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

60 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Beijing Chest Hospital, Capital Medical University

Lead sponsor