NCT00775307

Adjuvant Pazopanib in Stage I NSCLC

A Randomized, Double-blind, Placebo-controlled Phase II-III Multi-centre Study to Evaluate the Effect of Adjuvant Pazopanib (GW786034) Versus Placebo on Post-surgical Disease-free Survival in Patients With Stage I Non Small Cell Lung Cancer and Tumor Size Equal or Inferior to 5 cm.

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Intergroupe Francophone de Cancerologie Thoracique · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate the efficacy and safety of pazopanib compared with placebo in patients with T \< or = 5 cm, N0 (stage I according to TNM 2009) completely resected NSCLC.

Detailed description

The study will be conducted in two phases as follows: * The Phase II component of the study will be a randomized, double-blind, placebo-controlled, multi-centre study performed in France only. After undergoing NSCLC resection, 140 patients will be randomized to receive either pazopanib 400 mg per day or placebo for 24 weeks. * The Phase III component of the study will be a randomized, double-blind, placebo-controlled, multi-centre study performed internationally. Patients who have completed the Phase II component of the study will be followed and included in the Phase III. Additional patients will also be recruited to a planned total of 355 patients per treatment arm. New patients will be randomized to receive either pazopanib 400 mg per day or placebo for 24 weeks.

Conditions

• Carcinoma, Non-Small-Cell Lung

Interventions

Type	Name	Description
DRUG	PAZOPANIB	400 mg/day (24 weeks)
DRUG	Placebo	Placebo 400 mg/day (24 weeks)

Timeline

• Start date: 2008-11-01
• Primary completion: 2015-12-01
• Completion: 2016-04-18
• First posted: 2008-10-20
• Last updated: 2019-09-24

Locations

40 sites across 1 country: France