E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated | Patients with small cell or non small cell lung cancer receiving platinum-based chemotherapy and developing Neutropenia due to chemotherapy. | |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | Information not present in EudraCT |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial | Demonstration of safety of XM 02 when administered for up to a maximum of six cycles in patients with lung cancer. | |
E.2.2 | Secondary objectives of the trial | Demonstration of efficacy of XM 02 (in the first cycle compared to Filgrastim) in patients with lung cancer. Evaluation of pharmacokinetic properties of XM 02 in comparison to Filgrastim. | |
E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria | Female and male patients of any ethnic origin with a diagnosis of lung cancer meeting all criteria listed below, will be included in the study. • Signed and dated written informed consent • Age ≥18 years • Patients with small cell lung cancer, histologically or cytologically documented • Patients with advanced disease non small cell lung cancer • Patients planned/eligible to receive a platinum-based, myelosuppressive chemotherapy requiring G-CSF support in the investigator’s opinion • Life-expectancy of at least 6 months • Chemotherapy naïve or have received no more than one previous regimen of chemotherapy • Completion of previous chemotherapy more than 4 weeks before randomisation • Eastern Cooperative Oncology Group (ECOG) performance status ≤2 • ANC ≥1.5 x 109/L • Platelets ≥100 x 109/L • Adequate hepatic, cardiac, and renal function for the chosen CTX regimen | |
E.4 | Principal exclusion criteria | Patients presenting with any of the following will not be included in the study: • Participation in a clinical trial within 30 days before randomisation • Previous exposure to Filgrastim, Pegfilgrastim or Lenograstim • Patient planned for non-myelosuppressive chemotherapy • Patient meeting any contraindication for the chosen chemotherapy regimen • Treatment with systemically active antibiotics within 72 hours before chemotherapy • Treatment with lithium • Candidate for combined chemo-/radiotherapy • Chronic use of oral corticosteroids (except low dose chronic treatment with ≤20 mg/day prednisolone or equivalent dose for chronic obstructive pulmonary disease) • Prior radiation therapy within 4 weeks before randomisation • Prior bone marrow or stem cell transplantation • Any illness or condition that in the opinion of the investigator may affect the safety of the patient or the evaluation of any study endpoint • Pregnant or nursing women are excluded. Women of child-bearing potential must agree to use a chemical or barrier contraceptive during the treatment period. | |
E.5 End points |
E.5.1 | Primary end point(s) | Primary evaluation criteria Safety • Incidence of adverse events • Changes of safety laboratory parameters • Immunogenicity (development of antibodies against study drug) Secondary evaluation criteria: Efficacy • Incidence of febrile neutropenia per cycle and across all cycles (febrile neutropenia defined as axillary body temperature of ≥38.5°C for more than one hour, and ANC <0.5 x 109/L) Confidential Page 25 of 75 • Duration of severe neutropenia (DSN), defined as grade 4 neutropenia with an ANC <0.5 x 109/L in cycles 1 and 4 • Depth of ANC nadir in cycles 1 and 4 • Times to ANC recovery in cycles 1 and 4 • Mortality Other • Pharmacokinetics in a subset of patients | |
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 | Yes |
E.6.6 | Pharmacokinetic | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description | comparison with marketed product | |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description | |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
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.8.5 | 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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned | |
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 | Last visit of the last patient undergoing the trial. | |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 4 |