CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 106 enrolled
Drug / intervention
Chemotherapy +2 moredrug
Likely dose
Chemotherapy 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/NCT01102231
NCT01102231Phase 2Completed
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Phase II Study of Pemetrexed + Cetuximab + Cisplatin With Concurrent Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)

Intergroupe Francophone de Cancerologie Thoracique·interventional·Posted Apr 13, 2010·Updated Feb 16, 2021

In Brief

A Phase 2 clinical trial evaluating Chemotherapy, ERBITUX, and 1 other intervention for Stage III Non-small Cell Lung Cancer. Completed, enrolled 106 participants across 38 sites.

Detailed Summary

Radiochemotherapy is a standard for the treatment of unresectable stage III non-small cell lung cancer. The investigators goal is to study the efficacy and the toxicity for a promising association of new agents (cetuximab and pemetrexed) with concurrent radiotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsStage III Non-small Cell Lung Cancer
CountriesFrance
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 13, 2010
Enrollment StartMar 1, 2010
Primary CompletionJan 1, 2014
Study CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 16.2 years ago

Interventions

Chemotherapydrug

Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles)

ERBITUXdrug

The initial dose of cetuximab (ERBITUX) is 400 mg/m² intravenously administered over 120 minutes, followed by 11 weekly infusions at 250 mg/m² IV over 60 minutes

Radiotherapyradiation

66 Gy (2 Gy by fraction, 5 fractions by week)