drugset / Trial / NCT01836341

Afatinib In Combination With Cisplatin Or Carboplatin + Pemetrexed In Patients With EGFR-Mutant Lung Cancers Undergoing Definitive Chemoradiation

NCT01836341

NaSingle-groupOpen-labelTreatment

Summary

The purpose of this Phase I study is to test the safety of combining afatinib with standard chemotherapy and radiation. The drug afatinib will be given before the chemotherapy and radiation therapy to shrink the tumor and evaluate how afatinib affects the patient. This study will then test the safety of afatinib at different dose levels when combined with the chemotherapy drugs cisplatin or carboplatin, and pemetrexed. These treatments will be given during radiation treatment and the drug afatinib will be continued after chemotherapy and radiation.

Timeline

Start
2013-04
Primary completion
2015-04
Completion
2015-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Afatinib Small molecule 20 mg
Subject Afatinib Small molecule 30 mg
Subject Afatinib Small molecule 40 mg
Background Carboplatin Small molecule
Background Cisplatin Other / unclassified
Background Pemetrexed Small molecule