Study of Serplulimab Plus Chemotherapy as Neoadjuvant Therapy for Limited-stage Small Cell Lung Cancer (LS-SCLC)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorGuangdong Provincial People's Hospital

About this trial

This investigator-initiated, open-label, prospective Phase II clinical trial, planned to take place across multiple centers in China. We aimed to evaluate the efficacy and safety of surgical resection or chemotherapy following serplulimab plus platinum-containing dual induction therapy for stage II-IIIB (N2) LS-SCLC

Eligibility criteria

Qualifiers

Voluntarily participate in clinical research and sign written informed consent

Male or female patients aged 18-75 years old (including the critical value)

Histologically or cytologically confirmed SCLC

Clinically diagnosed as IIB-IIIB ( N2) stage (AJCC 8th edition cancer staging)

Disqualifiers

Mixed SCLC confirmed by histology or cytology

Previously received systemic anti-tumor treatment for small cell lung cancer, including but not limited to chemotherapy, immunotherapy, and radiotherapy

Other active malignant tumors within 5 years or at the same time. Cured localized tumors, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, and carcinoma in situ of the breast, can be enrolled

Those who are planning to undergo or have received organs in the past or bone marrow transplant patients

Trial design

Treatments tested in this trial

  • 4 cycles of Serplulimab combined with etoposide and carboplatin or cisplatin

Treatment groups

45 Participants
are divided into 1 treatment group

Sponsors and collaborators

Guangdong Provincial People's Hospital

Lead sponsor

Liaoning Cancer Hospital & Institute

Collaborator

Guangzhou No.12 People's Hospital

Collaborator

Second Xiangya Hospital of Central South University

Collaborator