CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
Pertuzumab +1 moredrug
Likely dose
Pertuzumab 840 mgfrom 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/NCT00855894
NCT00855894Phase 2Completed
CompareCT.gov

An Open-label Phase II Multicenter Study of the Safety and Activity (as Measured by FDG-PET Imaging Changes) of the Combination of Erlotinib and Pertuzumab in Patients With Relapsed Non-small Cell Lung Cancer

Genentech, Inc.·interventional·Posted Mar 5, 2009·Updated May 21, 2013

In Brief

A Phase 2 clinical trial evaluating Pertuzumab and Erlotinib for Non-Small Cell Lung Cancer. Completed, enrolled 41 participants across 10 sites in 2 countries.

Detailed Summary

This was a Phase II, open-label, single-arm, single-stage, multicenter trial in patients with relapsed non-small cell lung cancer (NSCLC), with the objective of assessing the activity of the combination of erlotinib and pertuzumab on the basis of the endpoint of FDG-PET response rate.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer
CountriesAustralia, United States
CollaboratorsRoche Pharma AG

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 5, 2009
Enrollment StartMar 1, 2009
Primary CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 17.3 years ago

Interventions

Pertuzumabdrug

After a single administration of a loading dose of 840 mg IV, patients received a maintenance dose of 420 mg IV every 3 weeks (q3w).

Erlotinibdrug

Patients received 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.