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

Sponsor

Guangdong Association of Clinical Trials (Other)

Overall Status

Recruiting

CT.gov ID

NCT05957510

Collaborator

Guangdong Provincial People's Hospital (Other)

Enrollment

Location

Arm

29.7

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Small-cell Lung Cancer	Drug: Serplulimab	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 10, 2023

Anticipated Primary Completion Date :

Jun 30, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Serplulimab plus chemotherapy

Patients with EGFR-mutated NSCLC that has histologically transformed into SCLC, who have not received systematic anti-tumor therapy post-transformation.

Drug: Serplulimab

serplulimab 300mg, d1, q3w, iv. etoposide 100 mg/m2, d1-3, q3w, iv. carboplatin AUC 5 (up to 750mg), d1, q3w, iv.

Other Names:

etoposide

carboplatin

Outcome Measures

Primary Outcome Measures

Progression free survival (PFS) [From date of first dosing to first documented progression or death from any cause, whichever came first, assessed up to 2 years.]
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).

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Guangdong Provincial Perople's Hospital	Guangzhou	Guangdong	China

Sponsors and Collaborators

Guangdong Association of Clinical Trials
Guangdong Provincial People's Hospital

Investigators

Principal Investigator: Jin-Ji Yang, PhD, Guangdong Provincial People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jin-Ji Yang, Principal Investigator, Guangdong Association of Clinical Trials

ClinicalTrials.gov Identifier:

NCT05957510

Other Study ID Numbers:

CTONG2302 (HLX10IIT39)

First Posted:

Jul 24, 2023

Last Update Posted:

Jul 24, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Jin-Ji Yang, Principal Investigator, Guangdong Association of Clinical Trials

transformed SCLC, EGFR-mutated NSCLC

Additional relevant MeSH terms:

Small Cell Lung Carcinoma

Carboplatin

Etoposide

Study Results

No Results Posted as of Jul 24, 2023