CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 72 enrolled
Drug / intervention
Cetuximab +2 moredrug
Likely dose
Cetuximab 400mgfrom 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/NCT01109524
NCT01109524Phase 2Completed
CompareCT.gov

Cisplatin and Vinorelbine in Combination With Cetuximab as First Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer (NSCLC): a Single Arm Multicenter Safety Phase 2 Study

Eli Lilly and Company·interventional·Posted Apr 23, 2010·Updated Dec 24, 2015

In Brief

A Phase 2 clinical trial evaluating Cetuximab, Cisplatin, and 1 other intervention for Lung Neoplasms and 3 related conditions. Completed, enrolled 72 participants across 22 sites in 3 countries.

Detailed Summary

The purpose of the study is to determine if U.S. manufactured Cetuximab can be safely used for the treatment of Non-Small Cell Lung Cancer in combination with Cisplatin and Vinorelbine.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Neoplasms, Carcinoma, Cancer of the Lung, Non-Small-Cell Lung Carcinoma
CountriesCanada, Puerto Rico, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 23, 2010
Enrollment StartJul 1, 2010
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 16.2 years ago

Interventions

Cetuximabdrug

Vial, Intravenous, 400mg/m², week 1, then 250mg/m², Weekly, Until Progressive Disease (PD)/ Toxicity/Pt-PI Decision

Cisplatindrug

Vial, Intravenous, 80mg/m², Day 1 of each 21 day cycle, Maximum 6 cycles

Vinorelbinedrug

Vial, Intravenous, 25 mg/m², Day 1 and 8 of each 21 day cycle, Maximum 6 cycles