Conditions: Carcinoma, Non-Small-Cell Lung Lung Neoplasms
Keywords: Lung Cancer HKI-272 Neratinib Nerlynx
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 172
Healthy volunteers: no

Brief summary:
The purpose of this study is to learn whether HKI-272 is safe and effective in treating non-small cell lung cancer.

Detailed description:

Arms:
arm 1: HKI-272 administered to patients whose disease has progressed following \> or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor with an EGFR mutation demonstrated at screening arm 2: HKI-272 administered to patients whose disease has progressed following \> or = 12 weeks of treatment with Tarceva or Iressa and who have a tumor without an EGFR mutation demonstrated at screening arm 3: HKI-272 administered to patients with no prior EGFR tyrosine kinase inhibitor treatment, adenocarcinoma, \< or = 20 pack-year smoking history, and current non-smoker (no requirement for EGFR mutation)

Interventions: intervention 1: HKI-272
Intervention descriptions: intervention 1: 320mg or 240mg daily by mouth. The starting dose was reduced from 320mg to 240mg per amendment #1 to the protocol for subject safety and tolerability.

Protocol document: