CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 137 enrolled
Drug / intervention
Olaratumab +2 morebiological
Likely dose
Olaratumab 15 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/NCT00918203
NCT00918203Phase 2Completed
CompareCT.gov

A Randomized Phase 2 Study of Human Anti-PDGFRα Monoclonal Antibody (IMC-3G3) With Paclitaxel/Carboplatin or Paclitaxel/Carboplatin Alone in Previously Untreated Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Eli Lilly and Company·interventional·Posted Jun 11, 2009·Updated Jan 10, 2019

In Brief

A Phase 2 clinical trial evaluating Olaratumab, Paclitaxel, and 1 other intervention for Non-Small Cell Lung Cancer. Completed, enrolled 137 participants across 23 sites in 2 countries.

Detailed Summary

The purpose of this study is to determine if participants with untreated locally advanced or metastatic non-small cell lung cancer have a better outcome when treated with olaratumab in combination with paclitaxel/carboplatin then when treated with paclitaxel/carboplatin alone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 11, 2009
Enrollment StartJan 1, 2010
Primary CompletionAug 1, 2013
Study CompletionNov 17, 2017
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 17.1 years ago

Interventions

Olaratumabbiological

15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered intravenously (IV) at 25 milligram/minute (mg/min), with a minimum infusion time of 30 minutes.

Paclitaxeldrug

200 mg/m2 is then administered IV over 3 hours

Carboplatindrug

AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months.