CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 62 enrolled
Drug / intervention
neratinib +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01827267
NCT01827267Phase 2Completed

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

Puma Biotechnology, Inc.·interventional·Posted Apr 9, 2013·Updated Jul 3, 2018

In Brief

A Phase 2 clinical trial evaluating neratinib and temsirolimus for HER2-mutant Non-Small Cell Lung Cancer. Completed, enrolled 62 participants across 21 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 9, 2013
Enrollment StartJul 1, 2013
Primary CompletionSep 20, 2016
Study CompletionOct 6, 2017
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 13.2 years ago

Interventions

neratinibdrug

temsirolimusdrug