CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
pemetrexed +2 moredrug
Likely dose
Pemetrexed 500 mg/m² IV every 21 days for 3 cycles; Cisplatin 75 mg/m² IV every 21 days for 3 cyclesAI-extracted
Key inclusion· 5
  • ✓Pathologically documented non-small cell lung cancer (NSCLC)
  • ✓Tumor accessible by bronchoscopy for tissue sampling
  • ✓Clinical stage IB, II, or IIIA disease
  • ✓ECOG performance status 0 or 1
Key exclusion· 5
  • ✕Bronchoalveolar carcinoma histology
  • ✕Stage IIIA Pancoast tumor (superior sulcus involvement)
  • ✕Pregnant or breastfeeding
  • ✕Prior malignancy within 5 years (except skin in situ carcinoma; excludes melanoma, breast cancer, hypernephroma)

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

Search/NCT00191308
NCT00191308Phase 2Completed
CompareCT.gov

Molecular Profiling and Safety Study of Operable Lung Cancer Patients Treated With Alimta Combined With Cisplatin as Neoadjuvant Chemotherapy

Eli Lilly and Company·interventional·Posted Sep 19, 2005·Updated Oct 21, 2011

In Brief

A Phase 2 clinical trial evaluating pemetrexed, cisplatin, and 1 other intervention for Non-Small Cell Lung Cancer and Carcinoma. Completed, enrolled 30 participants across 3 sites.

Detailed Summary

The main purpose of this study of pemetrexed combined with cisplatin used as neoadjuvant chemotherapy (2 or 3 cycles) in participants with operable non-small cell lung cancer (NSCLC) is to look at various genes present in participants' blood and tumor tissue to see if there is any link between the levels or changes in the genes and how participants with lung cancer respond to pemetrexed and cisplatin treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNon-Small Cell Lung Cancer, Carcinoma
CountriesPoland
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartMay 1, 2005
Primary CompletionJul 1, 2008
Study CompletionDec 1, 2010
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 20.8 years ago

Interventions

pemetrexeddrug

500 mg/m\^2 IV q 21 days for 3 cycles unless disease progression occurs

cisplatindrug

75 mg/m\^2 IV q 21 days for 3 cycles unless disease progression occurs

Radical Non-Small Cell Lung Cancer (NSCLC) surgeryprocedure

All participants proceeded to surgery within 4-8 weeks from the last dose of pemetrexed.