E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The trial will be conducted in patients with non-small cell lung cancer in stage IIIb - IV |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029521 |
E.1.2 | Term | Non-small cell lung cancer stage IIIB |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10029522 |
E.1.2 | Term | Non-small cell lung cancer stage IV |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the accuracy of FDG-/FLT-PET analyses for early prediction non-progression in patients with NSCLC treated with erlotinib |
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E.2.2 | Secondary objectives of the trial |
1. PET characteristics for progressive disease following erlotinib treatment 2. PET characteristics for response to erlotinib 3. PET characteristics for stable disease following erlotinib treatment 4. statistical association of EGFR mutational status and clinical response in NSCLC patients treated with erlotinib 5. statistical association of KRAS mutational status and clinical resistance to treatment of NSCLC patients with erlotinib 6. discriminatory capability of FDG-/FLT- PET regarding EGFR and KRAS mutational status in NSCLC patients 7. prognostic value of FDG-PET, FLT-PET and EGFR mutational status regarding clinical response in NSCLC patients treated with erlotinib 8. EGFR and KRAS sequence characteristics for clinical response and stable disease following erlotinib treatment 9. safety of Erlotinib 10. response rates 11. rates of stable diseases 12. one-year FFTF 13. one-year OS |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Response to therapy with erlotinib, FLT and FDG standard uptake values |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |