CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 49 enrolled
Drug / intervention
Trastuzumab Emtansinedrug
Likely dose
Trastuzumab Emtansine 3.6 mg/kgfrom 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/NCT02289833
NCT02289833Phase 2Completed

A Phase 2, Multicenter, Single-Arm Study of Trastuzumab Emtansine in Patients With HER2 IHC-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Received At Least One Prior Chemotherapy Regimen

Hoffmann-La Roche·interventional·Posted Nov 13, 2014·Updated Aug 7, 2019

In Brief

A Phase 2 clinical trial evaluating Trastuzumab Emtansine for Non-Small Cell Lung Cancer. Completed, enrolled 49 participants across 23 sites in 7 countries.

Detailed Summary

This is a Phase 2, multicenter study designed to evaluate the efficacy and safety of trastuzumab emtansine administered as a single-agent in participants with HER2-positive (HER2 IHC 2+ or HER2 IHC 3+) advanced or metastatic NSCLC. Participants will be treated with trastuzumab emtansine administered intravenously at a dose of 3.6 milligrams per kilogram (mg/kg) on Day 1 of 21-day cycles until disease progression (as assessed by the investigator), unmanageable toxicity, or study termination by the Sponsor, whichever occurs first.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, Italy, Poland, South Korea, Spain, Switzerland, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 13, 2014
Enrollment StartDec 15, 2014
Primary CompletionOct 25, 2016
Study CompletionAug 20, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 11.6 years ago

Interventions

Trastuzumab Emtansinedrug

Trastuzumab emtansine will be administered intravenously (IV) at a dose of 3.6 mg/kg on Day 1 of every 21-day cycle until disease progression (as assessed by the investigator), unmanageable toxicity, or study termination by the sponsor, whichever occurs first.