Safety and Efficacy of XM 02 in patients with small cell or non small cell lung cancer receiving platinum-based chemotherapy. Multinational, multicentre, randomised, controlled study

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 240

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
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

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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