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Nivolumab and Ipilimumab Plus Chemotherapy for Patients With Stage IV Lung Cancer With Brain Metastases — NIVIPI-Brain  

Lung Cancer Clinical Trial

Official title:
Nivolumab Plus Ipilimumab Plus Two Cycles of Platinum-based Chemotherapy as First Line Treatment for Stage IV/Recurrent Non-small Cell Lung Cancer (NSCLC) Patients With Synchronous Brain Metastases

Clinical Trial Summary

This is an open-label, non-randomised, phase II, multicenter clinical trial. 71 stage IV or recurrent, non-small cell lung cancer patients with synchronous brain metastases will be enrolled in this trial to evaluate the efficacy of Nivolumab plus Ipilimumab plus two cycles of platinum-based chemotherapy as first line treatment.

Clinical Trial Description

This is an open-label, non-randomised, phase II, multicenter clinical trial. The total sample size is 71 patients. The population to be included are stage IV or recurrent, non-small cell lung cancer patients with synchronous brain metastases. Patients randomised will receive induction treatment with two cycles of platinum-based chemotherapy plus Nivolumab and Ipilimumab. At the end of induction treatment the patient with start maintenance with Nivolumab and Ipilimumab until disease progression, unacceptable toxicity, loss of clinical benefit as judged by the investigator or up to a maximum of 2 years of treatment The primary objective of this trial is to determine the rate of intracranial clinical benefit, defined as the percentage of patients who had lack of radiological or clinical progression for at least 6 months according to RANO-BM assessment criteria. Patient accrual is expected to be completed within 1.5 years, treatment is planned to extend for 1 year and the patients will be followed up for 2 years. The study will end once survival follow-up has concluded. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05012254
Study type Interventional
Source Fundación GECP
Contact Eva Pereira
Phone 934302006
Email gecp@gecp.org
Status Recruiting
Phase Phase 2
Start date November 18, 2021
Completion date December 15, 2026
View Details
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