OncRef

Clinical Trial: NCT01827267

Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung Cancer

Status:

COMPLETED

Phase:

Phase 2

Lead Sponsor:Puma Biotechnology, Inc.
Information Provided By:Puma Biotechnology, Inc.
Last Update Posted:2018-07-03

Study Overview

Brief Summary

This is a Phase 2, therapeutic-exploratory, adaptive design, open-label, multicenter, multinational study evaluating neratinib monotherapy and neratinib plus temsirolimus combination therapy in patients with non-small cell lung cancer (NSCLC) who have documented somatic HER2 mutations.

Official Title

A Phase 2 Study of Neratinib and Neratinib Plus Temsirolimus in Patients With Non-Small Cell Lung Cancer Carrying Known HER2 Activating Mutations

Conditions

HER2-mutant Non-Small Cell Lung Cancer

Intervention / Treatment

  • Drug: neratinib
  • Drug: temsirolimus

Other Study ID Numbers

  • PUMA-NER-4201
  • 2012-004743-68

Start Date (Actual)

2013-07-01

Primary Completion Date (Actual)

2016-09-20

Study Completion Date (Actual)

2017-10-06

Enrollment (Actual)

62

Study Type

Interventional

Phase

Phase 2