drugset / Trial / NCT01156545

BIBW 2992 Plus Simvastatin vs. BIBW 2992 in Previously Treated Patients With Advanced Non-adenocarcinomatous NSCLC

NCT01156545

RandomizedParallel-groupOpen-labelTreatment

Summary

The investigators hypothesized that simvastatin may enhance sensitivity to BIBW 2992 in non-adenocarcinoma that is relatively resistant to TKIs. Based on these data, the investigators will research the effectiveness comparing BIBW2992, an irreversible EGFR-TKI, plus simvastatin with BIBW2992 alone in the setting of a randomized phase II study in previously treated patients with advanced non-adenocarcinomatous non-small cell lung cancer (NSCLC).

Timeline

Start
2010-10
Primary completion
2016-12-31
Completion
2021-06-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Afatinib Small molecule 40 mg Oral
Subject Simvastatin Small molecule 40 mg Oral