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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05873790
• Other study ID #: 23K048-001
• Status: Not yet recruiting
• Start date: June 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2023
• Source: The First Hospital of Jilin University
• Contact: Kewei Ma
• Phone: 0431-88782179
• Email: makw[@]jlu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Key Inclusion Criteria:

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 2.

• Have previously untreated and confirmed by histological and imaging examinations as extensive small cell lung cancer

• Adequate organ function and expected survival time = 12 weeks;

• Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.

Key Exclusion Criteria:

• Presence of mixed carcinoma component on histology.

• Patients with other active malignancies within 5 years prior to enrollment.

• Known active autoimmune diseases.

• Currently participate in an interventional clinical study treatment or have been treated with another drug or investigational device within 4 weeks prior to the first dose.

• Use of immunosuppressive agents within 14 days prior to the first dose of study treatment.

• Presence of other uncontrolled serious medical conditions.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• Serplulimab plus 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
The First Hospital of Jilin University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS)	Defined as the time from the first dose of study drug to tumor progression or death due to any cause.	One year after the end of chemotherapy
Secondary	Overall Survival (OS)	Defined as the time from the first dose of study drug to death due to any cause.	One year after the end of chemotherapy
Secondary	Objective Response Rate (ORR)	Defined as the percentage of participants having complete response or partial response to protocol treatment. Objective response will be measured by RECIST 1.1.	One year after the end of chemotherapy
Secondary	Disease-Control Rate (DCR)	Defined as the proportion of patients with complete response, partial response, and stable disease.	One year after the end of chemotherapy