Non Small Cell Lung Cancer MedDRA version: 12.0 Level: LLT Classification code 10025054 Term: Lung cancer non-small cell stage IIIB MedDRA version: 12.0 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV
Conditions
Sponsors
BioGeneriX AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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).;Secondary Objective: Safety and tolerability of XM22. Evaluation of pharmacokinetic properties of XM22. ;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 | — |
Countries
Bulgaria
Outcome results
None listed