Safety and Efficacy Evaluation of Serplulimab Plus Chemo in SCLC Transformed From EGFR-mutated NSCLC After Treatment

Study Overview
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Brief Summary
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This investigator-initiated, open-label, prospective Phase II clinical trial, planned to take place across multiple centers in China. We design this trial to evaluate the safety and efficacy of Serplulimab plus chemotherapy in SCLC transformed from EGFR-mutated NSCLC after treatment.

Detailed Description
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We plan to enroll 36 participants with EGFR-mutated NSCLC that has transitioned to SCLC following treatment. These individuals have not undergone systematic anti-cancer therapy post-transformation. Participants will undertake a combination chemotherapy regimen, comprised of serplulimab (300mg), etoposide (100 mg/m2), and carboplatin (AUC 5 mg/mL/min, up to 750mg). These agents will be administered intravenously in 3-week intervals over a span of 4 to 6 cycles.

Official Title
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Evaluation of Safety and Efficacy of Serplulimab Plus Chemotherapy in Patients With Histological Transformation From EGFR-mutated NSCLC to SCLC After Treatment: a Single-arm, Multicenter, Open-label Phase II Study

Conditions
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Small-cell Lung Cancer

Intervention / Treatment
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* Drug: Serplulimab


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 18 years-75 years Histological transformation from EGFR-mutated NSCLC to SCLC after treatment No systemic therapy or immunotherapy targeting T-SCLC, anti-PD-1/L1 or CTLA-4 should have been administered after the histologic transformation( immunotherapy prior to transformation is acceptable, but the last line of therapy prior to transformation cannot include immunotherapy) ECOG PS 0 or 1 At least one measurable target lesion based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) criteria identified within the four weeks leading up to the initial treatment dose Expected life expectancy of 12 weeks or more Adequate organ function Exclusion Criteria: Pathological reports post the histologic transformation not provided Active central nervous system (CNS) metastases and/or carcinomatous meningitis identified during the screening phase (Exceptions will be made for patients with asymptomatic brain metastases or those who have had stable brain metastases for at least 2 months after treatment) Other active malignancies either concurrently or within the past five years Received Curative radiation therapy within the three months leading up to the first treatment dose

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Serplulimab plus chemotherapy<br>Patients with EGFR-mutated NSCLC that has histologically transformed into SCLC, who have not received systematic anti-tumor therapy post-transformation. | Drug: Serplulimab<br>* serplulimab 300mg, d1, q3w, iv. etoposide 100 mg/m2, d1-3, q3w, iv. carboplatin AUC 5 (up to 750mg), d1, q3w, iv.<br>* Other names: carboplatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) | PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST v1.1). | From date of first dosing to first documented progression or death from any cause, whichever came first, assessed up to 2 years. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1. | Up to 2 years | 
| Overall survival (OS) | OS is the time from the date of first dosing date to death due to any cause. | Up to approximately 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transformed SCLC, EGFR-mutated NSCLC