Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05765825
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2023-03-01
Brief Title:
Study of Low-Dose Radiotherapy Concurrent Chemotherapy With Serplulimab for Patients With ES-SCLC
Sponsor:
Sichuan University
Organization:
Sichuan University
Study Overview
Official Title:
Phase II Single-Arm Study of Low-Dose Radiotherapy LDRT Concurrent CisplatinCarboplatin Plus Etoposide With Serplulimab for Patients With Extensive-Stage Small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase II single arm multicenter study designed to evaluate the safety and efficacy of low-dose radiotherapy LDRT concurrent cisplatincarboplatin plus etoposide with serplulimab in participants who have extensive-stage small cell lung cancer ES-SCLC and are chemotherapy-navïe for their extensive-stage disease
Detailed Description:
Enrolled patients will receive the following treatment regimen LDRT-concurrent cisplatincarboplatin plus etoposide in combination with serplulimab The induction period consists of 4 cycles of 21 days each Low-dose radiotherapy at 15Gy5f will be performed concurrently from Day 1 to Day 5 D1-D5 of Cycle 1 An efficacy assessment will be performed at the end of Cycle 2 and one week before the start of Cycle 3 For patients with primary lung lesions intrathoracic lesions evaluated as small PR tumor shrinkage 80SDPD low-dose radiotherapy at 15Gy5f will be performed in addition to serplulimab with chemotherapy in Cycle 3 For subjects evaluated as PDSDPR with extrathoracic residual metastases low-dose radiotherapy at 15Gy5f will be performed in addition to serplulimab with chemotherapy in Cycle 4 Definition of extrathoracic lesions for radiotherapy Metastases to liver metastases to adrenals and metastases to lymph nodes at the discretion of the investigator
After the induction period the subjects will continue to receive maintenance treatment with serplulimab Prophylactic cranial irradiation PCI is allowed for treatment according to local standard of care Patients will be treated until loss of clinical benefit unacceptable toxicity withdrawal of informed consent or death whichever occurs first
After the induction period the subjects will continue to receive maintenance treatment with serplulimab Prophylactic cranial irradiation PCI is allowed for treatment according to local standard of care Patients will be treated until loss of clinical benefit unacceptable toxicity withdrawal of informed consent or death whichever occurs first
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None