drugset / Trial / NCT03800134

A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer

NCT03800134

Phase 3 Active not recruiting 825 enrolled AstraZeneca
RandomizedParallel-groupDouble-blindTreatment

Summary

This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international study assessing the activity of durvalumab and chemotherapy administered prior to surgery compared with placebo and chemotherapy administered prior to surgery in terms of pathological complete response.

Timeline

Start
2018-12-06
Primary completion
2022-11-10
Completion
2028-09-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Durvalumab Monoclonal antibody 1500 mg Intravenous
Background Carboplatin Small molecule Intravenous
Background Cisplatin Other / unclassified 75 mg/m2 Intravenous
Background Gemcitabine Small molecule 1250 mg/m2 Intravenous
Background Paclitaxel Small molecule 200 mg/m2 Intravenous
Background Pemetrexed Small molecule 500 mg/m2 Intravenous