E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with metastatic or locally advanced Non-small-cell lung cancer (NSCLC) |
Ikke-småcellet lungecancer hos voksne patienter |
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E.1.1.1 | Medical condition in easily understood language |
Patients with incurable lung cancer. |
Uheldbredelig lungecancer |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025044 |
E.1.2 | Term | Lung cancer |
E.1.2 | System Organ Class | 100000015855 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025055 |
E.1.2 | Term | Lung cancer non-small cell stage IV |
E.1.2 | System Organ Class | 100000015841 |
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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 |
Primary objectives: Evaluating the side effects (toxicity and feasibility, adverse events grade 2-5 (CTC)) during the first 84 days (12 weeks) of treatment.
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E.2.2 | Secondary objectives of the trial |
Secondary Objectives: Progression-free survival (PFS) The Disease Control Rate (CR + PR + SD, (SD > 4 months)). The duration of Disease Control Time to progression (TTP). The response rate (RR). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Written (personally dated and signed) informed consent. 2. Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and/or the follow-up schedule. 3. ECOG performance status 0-1 (also PS 2 after the first 6 patients if acceptable toxicity according to chapter 8: Toxicity and dose modifications. 4. Life expectancy ≥ 10 weeks 5. Cytological or Histological confirmed squamous and non-squamous NSCLC in 1st or 2nd line where the investigator finds the patient suitable. 6. First line in stage IV NSCLC and in stage IIIB not suitable for curative treatment. Second line after immunotherapy (minimum 3 weeks after the last immunotherapy). 7. Presence of ≥ 1 measurable lesion as per RECIST 1.1 which has not been previously irradiated. 8. Adequate bone marrow, hepatic and renal function as defined by the following laboratory values: •Absolute neutrophil count (ANC) ≥ 1.5 x 109/L. •Platelet count ≥ 100 x 109/L. •Haemoglobin ≥ 10 g/dL or ≥ 6.2 mmol/L. •Total serum bilirubin ≤ 1.5 x ULN (≤ 3 x ULN in case of liver metastases). •Liver transaminases ≤ 2.5 x ULN (≤ 5 x ULN in case of liver metastases). •Alkaline phosphatase ≤ 5 x ULN. •Adequate renal function 9. Palliative radiotherapy can be allowed but not to the sites used for evaluation of response. (See section 4.4). 10. Fertile men should use effective contraceptive prevention. Fertile women must be using a medically accepted method of contraception to avoid pregnancy during 2 months preceding registration, throughout the study period and up to 3 months after last dose of study treatment in such a manner that the risk of pregnancy is minimized. Women who may be pregnant should have a pregnancy test.
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E.4 | Principal exclusion criteria |
1. Patients with NSCLC disease suitable for curable treatment. 2. No recovery to ≥ G1 side effects (exception: alopecia) of any prior anti-neoplastic treatment. 3. Current peripheral neuropathy ≥ G2. 4. Dysphagia or inability to swallow oral medication. 5. Malabsorption syndrome or disease significantly affecting GI-function or major resection of the stomach or proximal small bowel that could affect absorption of oral vinorelbine. 6. Other serious illness or medical condition, such as but not limited to: a. Clinically significant cardiac disease or impaired cardiac function (such as: uncontrolled congestive heart failure requiring treatment; significant cardiac arrhythmia; conduction abnormality such as congenital long QT syndrome or high grade/complete AV-blockage; myocardial infarction within the previous 3 months, unstable angina pectoris, coronary artery bypass graft, coronary angioplasty or stenting, if < 3 months prior to registration; QTcF >480 msec at screening) 7. Unstable diabetes mellitus. 8. Uncontrolled hypercalcemia. 9. Clinically significant active infections (current or within the last 2 weeks prior to registration). 10. Previous organ allograft. 11. Concomitant treatment with strong CYP3A4-inhibitors or strong CYP3A4-inducers (discontinuation before registration is acceptable, if medically feasible and ethically acceptable). 12. Pregnant women.
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E.5 End points |
E.5.1 | Primary end point(s) |
Metronomic chemotherapy is not yet well validated in the clinic, and we still need to identify the best medications and optimal dosage and regimens. By developing an effective oral treatment with frequent, daily doses of Navelbine Oral, we expect to achieve the same therapeutic benefit against the disease, as achieved by higher dose of Navelbine, twice in three weeks, but with less toxicity. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The end of this trial will be reached at 4 months after last patient last treatment. There will be included 20 patients in this study. |
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E.5.2 | Secondary end point(s) |
Progression-free survival (PFS) The Disease Control Rate (CR + PR + SD, (SD > 4 months)). The duration of Disease Control Time to progression (TTP). The response rate (RR). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The end of this trial will be reached at 4 months after last patient last treatment. There will be included 20 patients in this study. |
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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 | No |
E.6.4 | Safety | Yes |
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 | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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 | Yes |
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 | No |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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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The end of this trial will be reached at 4 months after last patient last treatment. |
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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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |