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

BioGeneriX0 个研究点目标入组 240 人开始时间: 2004年10月28日最近更新: 2012年3月19日

试验速览

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•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

•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
•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.

发起方

BioGeneriX