CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 122 enrolled
Drug / intervention
pemetrexed +2 moredrug
Likely dose
pemetrexed 500 milligramsfrom 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/NCT00269152
NCT00269152Phase 2Completed
CompareCT.gov

A Randomized Phase 2 Study of Pemetrexed in Combination With Cisplatin or Carboplatin as Adjuvant Chemotherapy in Patients With Completely Resected Stage Ib or II Non-Small Cell Lung Cancer

Eli Lilly and Company·interventional·Posted Dec 23, 2005·Updated Aug 18, 2015

In Brief

A Phase 2 clinical trial evaluating pemetrexed, cisplatin, and 1 other intervention for Non-Small Cell Lung Cancer. Completed, enrolled 122 participants across 18 sites in 3 countries.

Detailed Summary

This study is a multicenter, open-label, two-arm, randomized, parallel Phase 2 feasibility study of pemetrexed in combination with either cisplatin (Arm A) or carboplatin (Arm B) as adjuvant combination-chemotherapy in participants with completely resected, stage Ib or IIa/IIb non-small cell lung cancer (NSCLC). A two-stage design will be employed independently for both treatment arms, with the possibility of stopping each treatment early for lack of feasibility.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer
CountriesFrance, Germany, Spain
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 23, 2005
Enrollment StartDec 1, 2005
Primary CompletionNov 1, 2007
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 20.5 years ago

Interventions

pemetrexeddrug

500 milligrams per square meter (mg/m\^2), intravenous (IV), every 21 days x 4 cycles

cisplatindrug

75 mg/m\^2, intravenous (IV), every 21 days x 4 cycles

carboplatindrug

area under the curve (AUC) 5 milligrams per milliliter\*minute (mg/ml\*min), intravenous (IV), every 21 days x 4 cycles