Ignite Creation Date:
2024-05-06 @ 4:05 PM
Last Modification Date:
2024-10-26 @ 2:03 PM
Study NCT ID:
NCT04865250
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2021-03-08
Brief Title:
Predicting Response to Neoadjuvant ATEZOLIZUMAB Plus CarboplatinNab Paclitaxel in Resectable Non-squamous NSCLC
Sponsor:
University Hospital Heidelberg
Organization:
University Hospital Heidelberg
Study Overview
Official Title:
Exploratory Study Evaluating the Potential of Immune Signature Profiling for Predicting Response in Patients With Resectable Stage II IIIA and Select IIIB T3N2 Only Non-squamous Non-Small Cell Lung Cancer NSCLC to Neoadjuvant ATEZOLIZUMAB Plus CarboplatinNab Paclitaxel
Status:
RECRUITING
Status Verified Date:
2024-05
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:
iReP
Brief Summary:
Exploratory study evaluating the potential of immune signature profiling for predicting response in patients with resectable Stage II IIIA and select IIIB T3N2 only non-squamous Non-Small Cell Lung Cancer NSCLC to neoadjuvant ATEZOLIZUMAB plus Carboplatinnab Paclitaxel
Atezolizumab is given as intravenous infusion at a fixed dose of 1200 mg day 1 of each 21-day cycle every 3 weeks for 3 cycles during the neoadjuvant treatment phase Carboplatin at an initial dose of AUC area under curve 5 mgmLmin intravenously day 1 of each 21-day cycle for 3 cycles during the neoadjuvant treatment Phase and Nab-Paclitaxel Abraxane at 100 mgm2 intravenously day 1 8 and 15 of each 21-day cycle for 3 cycles during the neoadjuvant treatment phase Surgery after the 3rd cycle Atezolizumab Carboplatin Nab-Paclitaxel is standard procedure
Atezolizumab is given as intravenous infusion at a fixed dose of 1200 mg day 1 of each 21-day cycle every 3 weeks for 3 cycles during the neoadjuvant treatment phase Carboplatin at an initial dose of AUC area under curve 5 mgmLmin intravenously day 1 of each 21-day cycle for 3 cycles during the neoadjuvant treatment Phase and Nab-Paclitaxel Abraxane at 100 mgm2 intravenously day 1 8 and 15 of each 21-day cycle for 3 cycles during the neoadjuvant treatment phase Surgery after the 3rd cycle Atezolizumab Carboplatin Nab-Paclitaxel is standard procedure
Detailed Description:
In early stages of non-small cell lung cancer NSCLC surgical treatment with curative intent is the treatment of choice Adjuvant chemotherapy is standard of care for fully resected stage II IIIA or select IIIB T3N2 NSCLC to improve survival outcome as compared to surgery alone Neoadjuvant platinum-based chemotherapy has become a widely accepted alternative therapy Chemotherapy regimens used in the adjuvant and neoadjuvant settings consist of platinum-based doublets With the successful development of cancer immunotherapy in advanced NSCLC several neoadjuvant studies of anti-PD-1PD-L1 inhibitors are currently being conducted in resectable early-stage NSCLC
The IREP study explores neoadjuvant immunochemotherapy with three cycles of atezolizumab carboplatin and nab-paclitaxel in patients with histologically confirmed and resectable non-squamous NSCLC Stage II IIIA or select IIIB T3N2 only The primary endpoint of the study is the Major Pathologic Response MPR rate 10 residual viable tumor cells at surgery Secondary endpoints include EFS and OS safety endpoints as well as analyses of molecular and immunological biomarkers that are predictive of response to the neoadjuvant immunochemotherapy treatment
Atezolizumab is given as intravenous infusion at a fixed dose of 1200 mg day 1 carboplatin at an initial dose of AUC 5 mgmLmin intravenously day 1 and nab-paclitaxel at 100 mgm2 intravenously day 1 8 and 15 of each 21-day cycle every 3 weeks for 3 cycles during the neoadjuvant treatment phase Subsequent surgery is standard procedure with standard lobectomy bi-lobectomy with systematic lymph node dissection
The IREP study explores neoadjuvant immunochemotherapy with three cycles of atezolizumab carboplatin and nab-paclitaxel in patients with histologically confirmed and resectable non-squamous NSCLC Stage II IIIA or select IIIB T3N2 only The primary endpoint of the study is the Major Pathologic Response MPR rate 10 residual viable tumor cells at surgery Secondary endpoints include EFS and OS safety endpoints as well as analyses of molecular and immunological biomarkers that are predictive of response to the neoadjuvant immunochemotherapy treatment
Atezolizumab is given as intravenous infusion at a fixed dose of 1200 mg day 1 carboplatin at an initial dose of AUC 5 mgmLmin intravenously day 1 and nab-paclitaxel at 100 mgm2 intravenously day 1 8 and 15 of each 21-day cycle every 3 weeks for 3 cycles during the neoadjuvant treatment phase Subsequent surgery is standard procedure with standard lobectomy bi-lobectomy with systematic lymph node dissection
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