DUMAS: Neo-Adjuvant Immunotherapy for Pancoast Tumors — DUMAS  

NSCLC Clinical Trial

Official title: Phase II Clinical Trial of Neo-adjuvant Chemo/Immunotherapy Followed by Adjuvant Treatment Depending on the Resection Status for the Treatment of NSCLC Patients Diagnosed With Pancoast Tumor. A Multicenter Exploratory Study

Status Recruiting

Clinical Trial Summary

The goal of this clinical trial is to test the efficacy of induction treatment of immunotherapy and chemotherapy depending on the resection status for the treatment of non small cell lung cancer patients diagnosed with pancoast tumor. The main objectives it aims to answer are: - Complete resection rate after induction treatment with chemotherapy plus nivolumab - Overall Survival and Progression Free Survival at 24 months The sample size is 40 patients.

Clinical Trial Description

This is an open-label, phase II, single-arm, multi-centre clinical trial. The total sample size is 40 patients. The population to be included are previously untreated patients with histologically- or cytologically- documented NSCLC diagnosed with Pancoast tumor. Patients will receive Nivolumab 360mg + Paclitaxel 200mg/m2 + Carboplatin AUC6 for 3 cycles every 21 days (+/- 3 days) as neoadjuvant treatment followed by surgery and 6 months of adjuvant treatment with Nivolumab 480 mg Q4W (+/- 3 days) if applicable and depending on surgery results. Patients that will not receive adjuvant treatment will start follow up phase after end of treatment visit. Follow up for all patients must be done for 2 years. The primary objective is to evaluate the complete resection (R0) rate after induction treatment defined as the absence of residual tumor in patients treated with neoadjuvant chemo-immunotherapy.Secondary objectives and endpoint are Overall survival rate at 24 months and disease-free survival rate at 24 months. Patient accrual is expected to be completed within 2 years excluding a run-in-period of 3 months. Treatment and follow-up are expected to extend the study duration to a total of 5 years. The study will end once survival follow-up has concluded. ;

Related Conditions & MeSH terms

• NSCLC

• NCT number: NCT05684276
• Study type: Interventional
• Source: Fundación GECP
• Contact: Eva Pereira
• Phone: +34934302006
• Email: gecp@gecp.org
• Status: Recruiting
• Phase: Phase 2
• Start date: May 12, 2023
• Completion date: June 1, 2028