Patients with small cell or non small cell lung cancer receiving platinum-based chemotherapy and developing Neutropenia due to chemotherapy.
Conditions
Sponsors
BioGeneriX
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstration of safety of XM 02 when administered for up to a maximum of six cycles in patients with lung cancer.;Secondary Objective: 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.;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 | — |
Countries
Hungary, Lithuania
Outcome results
None listed