Clinical Trial

Predicting Response to Neoadjuvant ATEZOLIZUMAB Plus Carboplatin/Nab Paclitaxel in Resectable Non-squamous NSCLC

Study acronym: iReP
Recruiting Phase 2
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Record status
This record was last updated May 16, 2024 (before its estimated November 30, 2024 completion). Its status may not reflect the trial's current state.
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 Carboplatin/nab 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 mg/mL/min, intravenously day 1 of each 21-day cycle for 3 cycles during the neoadjuvant treatment Phase, and Nab-Paclitaxel (Abraxane) at 100 mg/m2, 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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2021-04-25.
Trial Details
NCT Number NCT04865250
Lead Sponsor University Hospital Heidelberg
Collaborators: Dietmar Hopp Stiftung
Conditions NSCLC Stage II, NSCLC, Stage IIIA, NSCLC Stage IIIB
Enrollment 20 participants
Start Date 2021-01-07
Primary Completion 2024-11-30 (estimated)
Study Completion 2026-12-30 (estimated)
Updated on ClinicalTrials.gov 2024-05-16