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

Sponsor
The First Hospital of Jilin University
Study ID
NCT05873790
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Serplulimab plus chemotherapy — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 1, 2023
Status verified
Apr 2023
Primary completion
Jun 30, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Serplulimab and chemotherapy
    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.

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: One year after the end of chemotherapy ]

Central Contacts

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