drugset
drugset / Trial / NCT05012254

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

NCT05012254 ↗

Phase 2 Active not recruiting 71 enrolled Fundación GECP
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2021-11-18
Primary completion
2027-10-15
Completion
2027-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Ipilimumab Monoclonal antibody 1 mg/kg Intravenous
Subject Nivolumab Monoclonal antibody 360 mg Intravenous
Background Carboplatin Small molecule 5 unknown Intravenous
Background Carboplatin Small molecule 6 unknown Intravenous
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous
Background Paclitaxel Small molecule 200 mg/m2 —
Background Pemetrexed Small molecule 500 mg/m2 Intravenous

Indications

metastatic malignant neoplasm in the brain non-small cell lung carcinoma