Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-26 @ 1:43 AM
Study NCT ID:
NCT06672133
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-05
First Post:
2024-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Adebrelimab Combined with Chemotherapy and Thoracic Radiotherapy for First-line Treatment of ES-SCLC
Sponsor:
Jinming Yu
Organization:
Study Overview
Official Title:
Adebrelimab Combined with Chemotherapy and Thoracic Radiotherapy for First-line Treatment of ES-SCLC: a Randomized Controlled Phase III Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
RALLY
Brief Summary:
This phase III trial compares the effect of adding radiation therapy to the usual maintenance therapy with adebrelimab versus adebrelimab alone in patients who have already received debrelimab plus chemotherapy for the treatment of extensive stage small cell lung cancer.
Detailed Description:
PRIMARY OBJECTIVES:
I.To compare investigator-assessed progression free survival (PFS) between adebrelimab plus radiotherapy and adebrelimab alone.
II.To compare overall survival (OS) between adebrelimab plus radiotherapy and adebrelimab alone.
SECONDARY OBJECTIVES:
I.To assess the ORR (objective response rate)、DoR (Duration of response) 、DCR(Disease control rate) toxicity between the adebrelimab plus radiotherapy arm and the adebrelimab arm.
II.To assess six months and one-year PFS rate、one-year and two-year OS rate between the adebrelimab plus radiotherapy arm and the adebrelimab arm.
III.To assess the safety and tolerability.
EXPLORATORY OBJECTIVE:
I.To detect biomarkers associated with efficacy OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive adebrelimab IV over 30 minutes. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo radiation therapy once daily (QD) on days 1-5 during weeks 1-5 only.
ARM II: Patients receive adebrelimab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients undergo computed tomography (CT)、magnetic resonance imaging (MRI) or positron emission tomography and computed tomography (PET/CT) scan, throughout the trial. Patients also undergo blood and tissue collection throughout the trial.
I.To compare investigator-assessed progression free survival (PFS) between adebrelimab plus radiotherapy and adebrelimab alone.
II.To compare overall survival (OS) between adebrelimab plus radiotherapy and adebrelimab alone.
SECONDARY OBJECTIVES:
I.To assess the ORR (objective response rate)、DoR (Duration of response) 、DCR(Disease control rate) toxicity between the adebrelimab plus radiotherapy arm and the adebrelimab arm.
II.To assess six months and one-year PFS rate、one-year and two-year OS rate between the adebrelimab plus radiotherapy arm and the adebrelimab arm.
III.To assess the safety and tolerability.
EXPLORATORY OBJECTIVE:
I.To detect biomarkers associated with efficacy OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive adebrelimab IV over 30 minutes. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo radiation therapy once daily (QD) on days 1-5 during weeks 1-5 only.
ARM II: Patients receive adebrelimab intravenously (IV) over 30 minutes on day 1. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients undergo computed tomography (CT)、magnetic resonance imaging (MRI) or positron emission tomography and computed tomography (PET/CT) scan, throughout the trial. Patients also undergo blood and tissue collection throughout the trial.
Study Oversight
Has Oversight DMC:
False
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?:
False
Is an FDA AA801 Violation?: