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A Phase-II Clinical Trial to Evaluate the Accuracy of FDG-/FLT-PET for Early Prediction of Non-progression in Patients With Advanced NSCLC Treated With Erlotinib and to Associate PET Findings With Molecular Markers


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Carcinoma, Non-Small-Cell Lung

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Trial Information

A Phase-II Clinical Trial to Evaluate the Accuracy of FDG-/FLT-PET for Early Prediction of Non-progression in Patients With Advanced NSCLC Treated With Erlotinib and to Associate PET Findings With Molecular Markers


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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Time Frame:

34 months

Safety Issue:

Yes

Principal Investigator

Juergen Wolf, Prof., Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Cologne, Lung Cancer Group Cologne

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

2005-005393-73

NCT ID:

NCT00568841

Start Date:

October 2007

Completion Date:

December 2009

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • advanced Non-Small-Cell Lung Cancer
  • erlotinib
  • FDG-PET
  • FLT-PET
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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