Trial of Afatinib in Combination With Weekly Paclitaxel in the Second Line Treatment
Status:
Withdrawn
Trial end date:
2015-08-12
Target enrollment:
Participant gender:
Summary
The investigators are doing this research program to find out if the investigational drug,
afatinib which is a medication known to block the function of the ErbB2 protein might help
standard chemotherapy, in particular paclitaxel, work better.
Afatinib (GILOTRIF) is a highly potent, irreversible inhibitor of the EGFR and HER2. On July
12, 2013 the United States Food and Drug Administration (US FDA) approved afatinib for the
first-line treatment of patients with metastatic non-small cell lung cancer whose tumors had
specific EGFR gene mutations (exon 19 deletions or exon 21 i.e. L858R substitution mutations)
as detected by an FDA approved test.
Paclitaxel is a standard, anti-cancer medicine that has been approved by the US Food and Drug
Administration (FDA) for the treatment of lung cancer.
The combination of Afatinib and Paclitaxel are considered investigational when used in this
research program. An investigational drug is a drug that is not approved by the FDA for its
indication.