E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Stage IB-II Non-Small Cell Lung Cancer (NSCLC) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10029518 |
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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 tolerability (in terms of drug delivery and toxicity) of Cisplatin / Pemetrexed as either induction or adjuvant chemotherapy in operable patients with stage IB-II NSCLC |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
♦ Pathological proven NSCLC. ♦ Performance status: WHO ≤ 2. ♦ Age > 18 years. ♦ Clinical stage IB-II NSCLC: cT2N0M0, cT1N1M0, cT2N1M0 or cT3N0M0. ♦ No evidence of mediastinal involvement as assessed by either mediastinoscopy and/or FDGPET scan. ♦ No evidence of metastatic disease as assessed by routine dissemination analysis according to institutional practice. ♦ Tumor considered resectable by multidisciplinary team. ♦ Presence of at least one measurable lesion (using RECIST criteria) ♦ No prior therapy for NSCLC (chemotherapy, radiotherapy or surgery). ♦ Adequate hematological function: ♦ ANC > 1.5 x 109/L ♦ Platelets> 100 x 109/L ♦ Hemoglobin > 10 g/dl (6,2 mmol/l) ♦ Adequate renal function: ♦ calculated creatinine clearance ≥ 60 ml/min (see appendix C for calculating the creatinine clearance according to the Cockroft-Gault formula) ♦ Adequate hepatic function: ♦ bilirubin ≤ 1.5 x ULN ♦ alkaline phosphatase ≤ 3.0 x ULN ♦ AST/ALT ≤ 3.0 x ULN ♦ The patient should be physically and mentally fit enough to receive chemotherapy in either adjuvant or neo-adjuvant setting and to undergo the proposed resection. A multidisciplinary team will confirm the required fitness. ♦ No other malignant disease, with the exception of basocellular carcinoma of the skin, adequately treated carcinoma in situ of the cervix, low-grade prostate cancer or other cancer from which the patient has been disease-free for at least last five years. ♦ No congestive heart failure or angina pectoris except if it is medically controlled. No previoushistory of myocardial infarction within 6 months prior to study entry, nor uncontrolled hypertension or arrhythmia. ♦ No active (uncontrolled) infection requiring antibiotics. ♦ No pre-existing motor or sensory neurotoxicity ≥ grade 2 (Common Terminology Criteria forAdverse Events, Version 3.0) ♦ Women of childbearing potential should have a negative pregnancy test and use adequate contraception during study treatment ♦ Before patient randomization, written informed consent will be obtained and documented according to ICH/GCP, and national/local regulations. |
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E.4 | Principal exclusion criteria | |
E.5 End points |
E.5.1 | Primary end point(s) |
"Success of treatment delivery" and "toxicity"
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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 | Yes |
E.6.5 | Efficacy | Yes |
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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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
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End of study occurs when all of the following criteria have been satisfied:
1. Thirty days after all patients have stopped protocol treatment 2. The trial is mature for the analysis of the primary endpoint as defined in the protocol 3. The database has been fully cleaned and frozen for this analysis
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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |