Trial intelligence / Profile preview

Icotinib with Concurrent Radiotherapy in EGFR+ NSCLC

NCT02883543Phase 3

Key facts

Status: Unknown
Start: Jun 2016
Primary completion: Jun 2018
Modality: Orthosteric Ligands

Drugs: icotinib
Conditions: non-small cell lung cancer (NSCLC)

Overview

Phase 3, randomised, open-label trial of icotinib in non-small cell lung cancer (NSCLC) (3 arms). Primary endpoints: Progression-free survival at 2 years and Incidence of radiation injury of the lungs at 2 years. Status: unknown.

Design

3 arms

Study design: RandomizedOpen-label

icotinib plus radiotherapy
Icotinib + Concurrent Radiotherapy
icotinib
Icotinib Monotherapy
chemotherapy plus radiotherapy
Chemotherapy + Concurrent Radiotherapy

Who it enrols

Patients with unresectable stage III or oligometastasis stage IV NSCLC with confirmed EGFR activating mutation. Brain metastasis is not permitted.

Endpoints

Primary

Progression-free survival2 years
Incidence of radiation injury of the lungs2 years

Secondary

Overall survival5 years
Tumor response after icotinib induction8 weeks
Quality of life2 years

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