NCT01102231

Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)

Phase II Study of Pemetrexed + Cetuximab + Cisplatin With Concurrent Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Intergroupe Francophone de Cancerologie Thoracique · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stage III Non-small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Chemotherapy	Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles)
DRUG	ERBITUX	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
RADIATION	Radiotherapy	66 Gy (2 Gy by fraction, 5 fractions by week)

Timeline

• Start date: 2010-03-01
• Primary completion: 2014-01-01
• Completion: 2015-12-01
• First posted: 2010-04-13
• Last updated: 2021-02-16
• Results posted: 2021-02-16

Locations

38 sites across 1 country: France