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

Primary Purpose

Small-cell Lung Cancer

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Serplulimab
Sponsored by
Guangdong Association of Clinical Trials
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small-cell Lung Cancer focused on measuring transformed SCLC, EGFR-mutated NSCLC

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Guangdong Provincial Perople's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Serplulimab plus chemotherapy

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
Overall survival (OS)
OS is the time from the date of first dosing date to death due to any cause.

Full Information

First Posted
July 5, 2023
Last Updated
July 20, 2023
Sponsor
Guangdong Association of Clinical Trials
Collaborators
Guangdong Provincial People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05957510
Brief Title
Safety and Efficacy Evaluation of Serplulimab Plus Chemo in SCLC Transformed From EGFR-mutated NSCLC After 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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2023 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Association of Clinical Trials
Collaborators
Guangdong Provincial People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Small-cell Lung Cancer
Keywords
transformed SCLC, EGFR-mutated NSCLC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Serplulimab plus chemotherapy
Arm Type
Experimental
Arm Description
Patients with EGFR-mutated NSCLC that has histologically transformed into SCLC, who have not received systematic anti-tumor therapy post-transformation.
Intervention Type
Drug
Intervention Name(s)
Serplulimab
Other Intervention Name(s)
etoposide, carboplatin
Intervention Description
serplulimab 300mg, d1, q3w, iv. etoposide 100 mg/m2, d1-3, q3w, iv. carboplatin AUC 5 (up to 750mg), d1, q3w, iv.
Primary Outcome Measure Information:
Title
Progression free survival (PFS)
Description
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).
Time Frame
From date of first dosing to first documented progression or death from any cause, whichever came first, assessed up to 2 years.
Secondary Outcome Measure Information:
Title
Objective Response Rate
Description
Objective response rate (ORR) is the proportion of subjects with complete response (CR) or partial response (PR), based on RECIST v1.1.
Time Frame
Up to 2 years
Title
Overall survival (OS)
Description
OS is the time from the date of first dosing date to death due to any cause.
Time Frame
Up to approximately 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Huang, PhD
Phone
13570957423
Email
huangjie@gdph.org.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin-Ji Yang, PhD
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong Provincial Perople's Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jie Huang, PhD
Email
huangjie@gdph.org.cn
First Name & Middle Initial & Last Name & Degree
Jinji Yang, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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