E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Advanced nonsquamous Non-small Cell Lung Cancer |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 15.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025054 |
E.1.2 | Term | Lung cancer non-small cell stage IIIB |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.0 |
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 | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 assess the adherence rate to pemetrexed administered in a
domiciliary setting. |
|
E.2.2 | Secondary objectives of the trial |
To assess resource utilization: distances traveled; number/length of visits; unplanned use of healthcare resources (ie, primary care, emergency, hospitalizations). To assess quality of life (QoL) and satisfaction with home care and time to treatment failure (TTF) and overall survival (OS) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients must have a histological or cytological diagnosis of Stage IIIB or Stage IV NSCLC defined as nonsquamous cell histology.
Patients must be at least 18 years of age
Patients must have completed 4 induction cycles of platinum based
doublet therapy (type at the discretion of the physician) and not progressed after induction therapy.
Have adequate organ function
Are willing to comply with the following contraceptive criteria
Have an estimated life expectancy of at least 12 weeks |
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E.4 | Principal exclusion criteria |
Have a serious concomitant systemic disorder
Have a serious cardiac condition
Are receiving concurrent administration of any other antitumor therapy
Are unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents
Have received a recent (within 30 days of enrollment) or are receiving
concurrent yellow fever vaccination
Have a second primary malignancy that in the judgment of the investigator and sponsor may affect the interpretation of results |
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E.5 End points |
E.5.1 | Primary end point(s) |
Adherence to treatment administration at home |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Starting at Day 1 of Cycle 1 until reversal to hospital administration or discontinuation from the study due to the domiciliary setting. |
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E.5.2 | Secondary end point(s) |
Time to treatment failure
Overall survival
QoL
Patient satisfaction
Resource utilisation |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Time to treatment failure: The time from the date of first dose of study treatment to the date of death from any cause, PD or discontinuation of pemetrexed due to toxicity.
Overall surival: The time from the date of the first dose of study treatment to the date of death from any cause. For patients not known to have died as of the cut off date, OS will be censored as the last contact date.
QoL: The EQ-5D and patient LCSS will be completed at baseline, day 1 of each cycle and at the 30 day postdiscontinuation visit.
Patient Satisfaction: to be conducted at the end of the study for all patients and on the day of infusion of cycle 4 for those patients who receive at least 4 maintenance cycles.
Resource Utilisation: To be completed at different timepoints of each cycle. |
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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 | No |
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 |
Patient Satisfaction, QoL and Resource Utilisation |
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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 | 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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 10 |
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
| |
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 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |