Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma

Lung Neoplasms

Small Cell Lung Carcinoma

Neoplasm, Residual

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Etoposide

Cisplatin

Etoposide phosphate

Participants receive 6 cycles of first-line Serplulimab plus chemotherapy, And MRD testing was performed before treatment, after 2 cycles of treatment, after 6 cycles of treatment, 6 months after the end of chemotherapy, and 1 year after the end of chemotherapy.

Serplulimab: 4.5 mg/kg via intravenous infusion on Day 1 of each 21-day cycle. Chemotherapy drugs: etoposide + carboplatin/cisplatin Etoposide: 300 mg/m2 via intravenous infusion, administered in 3-week (21 days) cycles for a maximum of 6 cycles.

Carboplatin: 300 mg/m2 via intravenous infusion, administered in 3-week (21 days) cycles for a maximum of 6 cycles.

Cisplatin: 75 mg/m2 via intravenous infusion, administered in 3-week (21 days) cycles for a maximum of 6 cycles.

Serplulimab plus chemotherapy

Kewei Ma

Small cell lung cancer (SCLC) is one of the most aggressive lung cancer subtypes, accounting for approximately 15-20% of total lung cancer cases. Although SCLC is relatively sensitive to chemotherapy, it is highly susceptible to recurrence. The advent of immunotherapy has revolutionized the clinical practice of oncology, and the newly released results of the ASTRUM-005 study have led to the incorporation of Serplulimab into the first-line treatment of extensive-stage SCLC. Although immunotherapy in combination with chemotherapy is currently the most promising regimen, due to the limited understanding of genetic alterations and the marked genetic heterogeneity of SCLC, treatment responsiveness varies greatly. Thus, there is an urgent need to find molecular biomarkers that can effectively predict prognosis and further suggest the effectiveness of this new treatment mode.

Minimal residual disease (MRD) refers to the presence of tumor cells disseminated from the primary lesion to distant organs in patients who lack any clinical or radiological signs of metastasis or residual tumor cells left behind after local therapy that eventually lead to local recurrence. These years, the development of real-time, high-sensitivity liquid biopsy assays have enabled the identification of MRD in individual patients with cancer. Multiple studies have demonstrated that detection of MRD dynamics following definitive therapy for solid cancers is strongly prognostic and has extremely high positive predictive value for risk of recurrence and treatment efficacy.

The aim of this study was to explore the predictive value of MRD dynamics on disease prognosis before and after the first-line treatment of Serplulimab in combination with chemotherapy for extensive-stage SCLC.

Minimal Residual Disease Dynamic Monitoring in First-Line Serplulimab Plus Chemotherapy in Treatment of Extensive Small Cell Lung Cancer: An Observational Study

A Prospective Observational Study of MRD Dynamic Monitoring in First-Line Serplulimab Plus Chemotherapy in Treatment of Extensive Small Cell Lung Cancer

Defined as the time from the first dose of study drug to tumor progression or death due to any cause.

Defined as the time from the first dose of study drug to death due to any cause.

Defined as the percentage of participants having complete response or partial response to protocol treatment. Objective response will be measured by RECIST 1.1.

Defined as the proportion of patients with complete response, partial response, and stable disease.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Minimal Residual Disease Dynamic Monitoring in First-Line Serplulimab Plus Chemotherapy in Treatment of Extensive Small Cell Lung Cancer: An Observational Study	NCT05873790	Lung Cancer	Serplulimab plu...	18 Years - 75 Years	The First Hospital of Jilin University
Minimal Residual Disease Dynamic Monitoring in First-Line Serplulimab Plus Chemotherapy in Treatment of Extensive Small Cell Lung Cancer: An Observational Study	NCT05873790	Lung Cancer	Serplulimab plu...	18 Years - 75 Years	The First Hospital of Jilin University

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