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

Lung Cancer Group Cologne

Status and phase: Unknown; Phase 2

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Procedure: FDG-/FLT-PET; Drug: erlotinib

Study type: Interventional

Funder types: Other

Identifiers

NCT00568841

2005-005393-73

06159

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

1

Experimental group

Treatment:

Drug: erlotinib

Procedure: FDG-/FLT-PET