Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-24 @ 5:08 PM
NCT ID:
NCT04865250
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 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.
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 (neo)adjuvant studies of anti-PD-1/PD-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 mg/mL/min intravenously day 1 and nab-paclitaxel at 100 mg/m2 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:
NCT04865250
Study Brief:
Protocol Section:
NCT04865250