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Completed Phase 2 Interventional Results available

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

ClinicalTrials.gov ID: NCT01827267

Public ClinicalTrials.gov record NCT01827267. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 2:12 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT01827267
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Puma Biotechnology, Inc.
Industry
Enrollment
62 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 1, 2013 (Actual)
Primary completion
Sep 20, 2016 (Actual)
Completion
Oct 6, 2017 (Actual)
Last update posted
Jul 3, 2018

2013 – 2017

United States locations

U.S. sites
15
U.S. states
11
U.S. cities
13
Facility City State ZIP Site status
City of Hope Duarte California 91010 —
University of California Los Angeles Santa Monica California 94040 —
University of Colorado Aurora Colorado 80045 —
Moffitt Cancer Center Tampa Florida 33612 —
Johns Hopkins Baltimore Maryland 21231 —
Beth Israel Deaconess Medical Center Boston Massachusetts 02215 —
Dana Farber Cancer Institute Boston Massachusetts 02215 —
Massachusettes General Hospital Boston Massachusetts 02215 —
Washington University School of Medicine St Louis Missouri 63110 —
Memorial Sloan-Kettering Cancer Center New York New York 10065 —
Ohio State University Columbus Ohio 43210 —
University of Pittsburgh Cancer Institute Pittsburgh Pennsylvania 15232 —
Vanderbilt University Nashville Tennessee 37232 —
UT Southwestern Medical Center Dallas Texas 75390 —
MD Anderson Cancer Center Houston Texas 77030 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01827267, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 3, 2018 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01827267 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →