A Phase II Clinical Trial to Evaluate the Accuracy of FDG-/FLT- PET for Early Prediction of Non-Progression in Patients with Advanced Non Small Cell Lung Cancer (NSCLC) treated with Erlotinib and to Associate PET Findings with Molecular Markers - ERLOPET

• Conditions: The trial will be conducted in patients with non-small cell lung cancer in stage IIIb - IV; MedDRA version: 8.1Level: LLTClassification code 10029521Term: Non-small cell lung cancer stage IIIB; MedDRA version: 9.1Level: LLTClassification code 10029522Term: Non-small cell lung cancer stage IV

• Registration Number: EUCTR2005-005393-73-DE
• Lead Sponsor: niversity Cologne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-14
• Last Update Posted: 22 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. First diagnosis of histologically proven advanced non-small cell lung cancer 2. Tumor tissue available and suitable for EGFR gene resequencing 3. At least one measurable lesion according to RECIST 4. No prior standard chemotherapy, immunotherapy or small-molecules therapy 5. = 18 years of age 6. ECOG performance status 0-2 7. Patient's own, written informed consent to participate in the trial 8. TSH, FT3 and FT4 serum levels compatible with contrast enhanced CT (no signs of hyperthyroidism) 9. Renal laboratory parameters compatible with contrast enhanced CT (serum creatinine ? 1,7 mg/dl) 10. No decompensated liver failure 11. No decompensated heart failure 12. No clinical or radiological sign of interstitial lung disease, no interstitial lung disease in the past 13. Life expectancy > 3 months 14. In case of female patients with childbearing potential: - negative pregnancy test - effective method of contraception
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Lack of appropriate biopsy specimen for EGFR gene re-sequencing 2. Previous systemic treatment of NSCLC (chemotherapy, immuntherapy, therapy with small molecules and others) 3. Concurrent systemic immune therapy, chemotherapy, or therapy with any anticancer drug not indicated in the study protocol 4. Solitary metastases accessible to surgical resection 5. Bone metastases which have to be treated by radiotherapy (e.g. impending fracture), if no additional metastases outside the radiation field are present 6. Tumor masses with acute risk of life-threatening complications (e.g. compression of large arteries or trachea) which require emergency treatment (e.g. radiotherapy) 7. Malignant disease other than NSCLC within the last 5 years (exceptions: basalioma, carcinoma in situ of the cervix uteri, completely resected melanoma pT1N0M0 (Clark level II)) 8. Infection with HIV, Hepatitis B, Hepatitis C 9. Patient's lack of accountability, inability to appreciate the nature, meaning and consequences of the trial and to formulate his/her own wishes adequately 10. 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 11. Any person being in an institution on assignment of the respective authority 12. Simultanous participation in any other clinical trial 13. Pregnancy, lactation 14. Diabetes mellitus 15. Elevated fasting blood glucose levels > 130 mg/dl (exception: reduction of an unexpectedly high blood glucose level to a value ? 130 mg/dl using regular insulin)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified