Ignite Creation Date:
2024-05-06 @ 12:33 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03798743
Status:
COMPLETED
Last Update Posted:
2022-03-02
First Post:
2019-01-05
Brief Title:
Phase II Study on Sintilimab Combined With Docetaxel for Chemotherapy Failure Advanced NSCLC the SUCCESS Study
Sponsor:
Hunan Province Tumor Hospital
Organization:
Hunan Province Tumor Hospital
Study Overview
Official Title:
Single Center Single Arm Phase II Study on Efficacy Evaluation and Bio-marker Analysis of Sintilimab Combined With Docetaxel for Double Platinum-based Chemotherapy Failure Advanced Non-small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2022-03
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:
SUCCESS
Brief Summary:
The study aim to Evaluate the combination of ididilimumab and docetaxel alone in the treatment of previous platinum-containing double-drug chemotherapy according to RECIST 11Objective remission rate of advanced or metastatic non-small cell lung cancer with negative driving gene negative EGFR ALK ROS1 ORR
Detailed Description:
This study is a single case of syndilizumab plus docetaxel monotherapy in a Chinese-negative late-stage or metastatic non-small cell lung cancer NSCLC failed platinum-containing dual-drug chemotherapy Center single arm phase II study In this study 30 patients with advanced or metastatic non-small cell lung cancer who had failed platinum-containing dual-drug chemotherapy were treated with rituximab plus docetaxel every 3 weeks until disease progression and intolerance Toxicity withdrawal of informed consent death or other cessation of treatment as prescribed by the program whichever occurs first The primary end point was the ORR based on RECIS 11 which was evaluated by the Independent Imaging Review Board IRRC The longest treatment time for ididibizumab is 24 months An interim analysis will be conducted during the course of the study The results and reports will be provided to the Independent Data Audit Committee IDMC which determines whether the trial is valid based on the valid cut-off value of the trial and whether the study data can be submitted in advance Make recommendations to the sponsor Prior to the interim analysis the IDMC charter will be finalized and approved by IDMC and the sponsor The responsibilities and related procedures of IDMC members will be defined in the IDMC charter
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