CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 755 enrolled
Drug / intervention
Paclitaxel (Taxane) +3 moredrug
Likely dose
Paclitaxel 225 mg/m² IV or Docetaxel 75 mg/m² IV plus Carboplatin AUC=6 every 3 weeks (6 cycles maximum), with or without Cetuximab 400 mg/m² initial dose then 250 mg/m² weekly starting week 2AI-extracted
Key inclusion· 5
  • ✓Advanced or metastatic NSCLC with no prior chemotherapy
  • ✓Bidimensionally measurable tumor lesions
  • ✓ECOG performance status 2 (able to do light/sedentary work)
  • ✓At least 4 weeks from prior major surgery or investigational agent; at least 12 weeks from chest radiation
Key exclusion· 8
  • ✕Any prior chemotherapy or adjuvant chemotherapy for lung cancer
  • ✕Prior cetuximab or EGFR-targeted therapy
  • ✕Prior severe infusion reaction to antibody therapy
  • ✕Symptomatic or uncontrolled CNS metastases (anticonvulsants allowed, glucocorticoids not)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00112294
NCT00112294Phase 3Completed
CompareCT.gov

A Randomized Multicenter Phase III Study of Taxane/Carboplatin/Cetuximab Versus Taxane/Carboplatin as First-Line Treatment for Patients With Advanced/Metastatic Non-Small Cell Lung Cancer

Eli Lilly and Company·interventional·Posted Jun 2, 2005·Updated Dec 24, 2015

In Brief

A Phase 3 clinical trial evaluating Paclitaxel (Taxane), Docetaxel (Taxane), and 2 other interventions for Non-Small-Cell Lung Carcinoma. Completed, enrolled 755 participants across 124 sites.

Detailed Summary

The primary purpose of this clinical research study is to learn if patients treated with the combination of Taxane/Carboplatin plus Cetuximab (C/T/C) have a longer progression-free survival than patients treated with Taxane/Carboplatin (T/C) alone. The safety of this treatment will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small-Cell Lung Carcinoma
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJun 2, 2005
Enrollment StartDec 1, 2004
Primary CompletionApr 1, 2007
Study CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 21.1 years ago

Interventions

Paclitaxel (Taxane)drug

IV, 225 mg/m\^2

Docetaxel (Taxane)drug

IV, 75 mg/m\^2

Carboplatindrug

AUC=6, q 3 weeks (6 cycles maximum)

Cetuximabdrug

Intravenous, 400 mg/m\^2, initial dose followed by 250 mg/m\^2, weekly starting on Week 2