Neo-DIANA: Neoadjuvant Treatment for EGFR Mutated Patients

Non Small Cell Lung Cancer Clinical Trial

Official title: A Phase II Trial of Neoadjuvant Treatment Carboplatin-Pemetrexed-Bevacizumab Plus Atezolizumab for the Treatment of Locally Advanced and Potentially Resectable NSCLC Patients With EGFR Mutations

Status Recruiting

Clinical Trial Summary

This is an open-label, non-randomised, phase II, multi-centre clinical trial

26 patients will be enrolled in this trial to evaluate the major pathologic response in patients with neoadjuvant treatment with Carboplatin Pemetrexed Bevacizumab plus Atezolizumab in patients with non-small cell lung carcinoma locally advanced mutated in EGFR

Clinical Trial Description

This is an open-label, non-randomised, phase II, multi-centre clinical trial. Patients enrolled will receive Atezolizumab 1200mg + Bevacizumab 15mg/Kg + Carboplatin AUC6 + Pemetrexed 500mg/m2 for 3 cycles every 21 days (+/- 3 days) as neoadjuvant treatment followed by surgery and 6 months of adjuvant treatment with Atezolizumab 1200 mg Q4W (+/- 3 days).

The primary objective is to evaluate the major pathologic response defined as 10 percent or fewer viable cancer cells detectable in the resected tumor and in lymph nodes in stage IIIA EGFR mutated patients treated in neoadjuvant setting with atezolizumab- bevacizumab- carboplatin and pemetrexed.

Patient accrual is expected to be completed within 2 years excluding a run-in-period of 3-6 months. Treatment and follow-up are expected to extend the study duration to a total of 6 years. Patients will be followed 3 years after adjuvant treatment. The study will end once survival follow-up has concluded. This will be followed by a close out period of 4 months. ;

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• EGFR Gene Mutation
• Non Small Cell Lung Cancer

• NCT number: NCT04512430
• Study type: Interventional
• Source: Fundación GECP
• Contact: Eva Pereira
• Phone: +34934302006
• Email: gecp@gecp.org
• Status: Recruiting
• Phase: Phase 2
• Start date: December 2, 2020
• Completion date: December 30, 2025