Efficacy and safety of XM22 in patients with non small cell lung cancer receiving cisplatin / etoposide chemotherapy.A multinational, multicentre, randomised, double-blind placebo-controlled study

• Conditions: on Small Cell Lung Cancer; MedDRA version: 12.0Level: LLTClassification code 10025054Term: Lung cancer non-small cell stage IIIB; MedDRA version: 12.0Level: LLTClassification code 10025055Term: Lung cancer non-small cell stage IV

• Registration Number: EUCTR2009-016000-22-BG
• Lead Sponsor: BioGeneriX AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-29
• Last Update Posted: 12 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 485

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified