CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 204 enrolled
Drug / intervention
Pemetrexed +3 moredrug
Likely dose
Pemetrexed 500 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/NCT00447057
NCT00447057Phase 2Completed
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A Phase 2 Study of Pemetrexed Versus Pemetrexed Plus Erlotinib in Second-Line Treatment in Patients With Nonsquamous NSCLC

Eli Lilly and Company·interventional·Posted Mar 13, 2007·Updated Oct 13, 2011

In Brief

A Phase 2 clinical trial evaluating Pemetrexed and Erlotinib for Histological or Cytological Diagnosis of Locally Advanced or Metastatic NSCLC of Nonsquamous Histology and Not Amenable to Curative Therapy.. Completed, enrolled 204 participants across 23 sites in 5 countries.

Detailed Summary

This is a multicenter, randomized, Phase 2, open label, parallel trial to evaluate an effect of pemetrexed alone on nonsquamous non-small cell lung cancer (NSCLC) in a second-line setting (such as progression-free survival \[PFS\], disease control rate, best response rate, time to treatment failure \[TTTF\], overall survival \[OS\] and 1-year survival rates) compared to pemetrexed plus erlotinib combination.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHistological or Cytological Diagnosis of Locally Advanced or Metastatic NSCLC of Nonsquamous Histology and Not Amenable to Curative Therapy.
CountriesAustria, Germany, Hungary, Spain, Sweden
Collaborators--

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 13, 2007
Enrollment StartMar 1, 2007
Primary CompletionJul 1, 2010
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 19.3 years ago

Interventions

Pemetrexeddrug

500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21-day cycle until disease progression (PD) or unacceptable toxicity

Erlotinibdrug

150 mg given orally (po), daily (QD), starting on the first day of the first cycle

Pemetrexeddrug

500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity

Erlotinibdrug

150 mg given po, QD, starting on the first day of the first cycle