E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non Small Cell Lung Cancer |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025054 |
E.1.2 | Term | Lung cancer non-small cell stage IIIB |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10025055 |
E.1.2 | Term | Lung cancer non-small cell 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 |
Demonstration of superiority of XM22 versus placebo when administered for up to a maximum of four cycles chemotherapy (CTX) in patients with non small cell lung cancer (NSCLC). |
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E.2.2 | Secondary objectives of the trial |
Safety and tolerability of XM22. Evaluation of pharmacokinetic properties of XM22.
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
1. PK substudy 2. Substudy for CD34+ cells mobilization properties of XM22 |
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E.3 | Principal inclusion criteria |
• Signed and dated written informed consent. • Men and women aged ≥18 years • The patient must be able to understand and follow instructions and must be able to participate in the study for the entire period. • Patients with squamous NSCLC stage IIIB/IV, histologically or cytologically documented. • Patients planned and eligible to receive 4 cycles of the predefined cisplatin / etoposide-based, myelosuppressive CTX. • Life-expectancy of at least 4 months. • CTX naive. • Eastern Cooperative Oncology Group (ECOG) performance status ≤2. • ANC ≥1.5 x 10(9)/L. • Platelets ≥100 x 10(9)/L. • Adequate hepatic, cardiac, bone marrow and renal function for the chosen CTX regimen. |
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E.4 | Principal exclusion criteria |
• Participation in a clinical trial within 30 days before randomisation. • Previous exposure to filgrastim, pegfilgrastim or lenograstim or other G-CSFs in clinical development less than 6 months before randomisation. • Known hypersensitivity to filgrastim, pegfilgrastim, lenograstim, cisplatin or etoposide. • Patient planned for non-myelosuppressive chemotherapy. • Patients with an individual high risk for febrile neutropenia in respect of the cisplatin/etoposide CTX according to the assessment of the investigator. Risk factors are age >65 years, low performance status, poor nutritional status, and liver, renal or cardiovascular disease. • Patient meeting any contraindication for the chosen CTX regimen. • Treatment with systemically active antibiotics within 72 hours before CTX. • Treatment with lithium at inclusion or planned during the entire study. • Patient to be treated with combined chemo-/radiotherapy during the foreseen participation in this study. • 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 or tumour surgery within 4 weeks before randomisation. • Prior bone marrow or stem cell transplantation. • Prior malignancy within the preceding 5 years other than non-melanoma skin cancer or in situ cervical carcinoma. • 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. Women of child-bearing potential who do not agree to use a highly effective method of birth control during the entire duration of the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy: Incidence of febrile neutropenia (FN) in the first cycle (FN defined as body temperature of >38.5°C for at least one hour, measured orally with a certified standard device, and ANC <0.5 x 10(9)/L including cases of neutropenic sepsis or neutropenic serious or life-threatening infection). Safety: Incidence of AEs; changes in vital signs and physical examination parameters; assessment of local tolerability at the injection site and of injection site reactions; changes of safety laboratory parameters; immunogenicity; number of transfusions; mortality; frequency of culture-confirmed infections; ECG monitoring
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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 | Yes |
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 |
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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) | 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 | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 27 |
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 |
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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 study will close when the last patient has completed his/her last visit (last antibody assessment on day 360) |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |