Erlotinib and Sequential Positron Emission Tomography (PET) in Advanced Non Small Cell Lung Cancer (NSCLC)

Phase 2

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: erlotinib; Procedure: FDG-/FLT-PET

• Registration Number: NCT00568841
• Lead Sponsor: Lung Cancer Group Cologne

Brief Summary

This is a Phase-II Study to evaluate the accuracy of Fluorodeoxyglucose-/Fluorothymidine-Positron Emission Tomography (FDG-/FLT-PET) analyses for early prediction of non-progression in patients with non-small-cell lung cancer (NSCLC) treated with Erlotinib.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Study First Submitted: 2007-12-05
• Study First Submitted QC: 2007-12-05
• Study First Posted: 2007-12-06
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-16
• Last Update Posted: 2009-09-17
• Primary Completion: 2009-12
• Study Completion: 2009-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Written informed consent
• ≥ 18 years of age
• Untreated non-small-cell lung cancer stage IIIB/IV
• Life expectancy > 3 months
• Performance status ECOG 0-2

Exclusion Criteria

• Concurrent systemic immune therapy, chemotherapy or therapy with any anticancer drug not indicated in the study protocol
• Any investigational agent(s) within 4 weeks prior to study entry
• Previous administration of any EGFR-targeted therapy (antibodies, small molecules and others)
• Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	erlotinib	-
1	FDG-/FLT-PET	-

Primary Outcome Measures

Name	Time	Method
To evaluate the accuracy of FDG-/FLT-PET analyses for early prediction of non-progression in patients with NSCLC treated with Erlotinib	34 months

Secondary Outcome Measures

Name	Time	Method
To identify PET characteristics for progression, response and stable disease; To identify EGFR and KRAS sequence characteristics for clinical response and stable disease; Safety; Response rates; One-year FFTF; One-year OS; Median overall survival time	34 months

Trial Locations

Locations (1)

Center for Integrated Oncology, University Hospital Cologne, Department I of Internal Medicine, Kerpenerstr.62; 🇩🇪 Cologne, Germany