NSCLC patients with chemotherapy induced neutropenia Cancer Malignant neoplasm of bronchus and lung
Conditions
Interventions
XM22: 1 syringe 6 mg per cycle (cycles 1-4)
Placebo: 1 syringe per cycle (cycles 1-4)
The duration of the study will be 12 weeks. The duration of follow up will be 360
Sponsors
BioGeneriX AG (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provide signed and dated written informed consent 2. Men and women aged =18 3. The patient must be able to understand and follow instructions and must be able to participate in the study for the entire period 4. Patients with NSCLC stage IIIB/IV, histologically or cytologically documented 5. Patients planned and eligible to receive 4 cycles of the predefined cisplatin / etoposide-based, myelosuppressive CTX 6. Life-expectancy of at least 4 months 7. CTX naïve 8. Eastern Cooperative Oncology Group (ECOG) performance status =2 9. Absolute Neutrophil Count (ANC) =1.5 x 10*9/L 10. Platelet count =100 x 10*9/L 11. Adequate hepatic function, i.e. ALT and AST <2.5 x ULN, alkaline phosphatase <5 x ULN, bilirubin <ULN 12. Adequate renal function, i.e. creatinine <1.5 x ULN 13. Adequate hepatic, cardiac, bone marrow and renal function for the chosen CTX regimen
Exclusion criteria
Exclusion criteria: 1. Participation in a clinical trial within 30 days before randomisation. 2. Previous exposure to filgrastim, pegfilgrastim or lenograstim or other G-CSFs in clinical development less than 6 months before randomisation. 3. Known hypersensitivity to filgrastim, pegfilgrastim, lenograstim, cisplatin or etoposide. 4. Patient planned for non-myelosuppressive CTX. 5. 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. 6. Patient meeting any contraindication for the chosen CTX regimen. 7. Treatment with systemically active antibiotics within 72 hours before CTX. 8. Treatment with lithium at inclusion or planned during the entire study. 9. Patient to be treated with combined chemo-/ radiotherapy during the foreseen participation in this study. 10. Chronic use of oral corticosteroids (except low dose chronic treatment with =20 mg/day prednisolone or equivalent dose for chronic obstructive pulmonary disease). 11. Prior radiation therapy or tumour surgery within 4 weeks before randomisation. 12. Prior bone marrow or stem cell transplantation. 13. Prior malignancy within the preceding 5 years other than non-melanoma skin cancer or in situ cervical carcinoma. 14. 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. 15. 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. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, sexual abstinence or vasectomised partner. Female patients will be considered to be of child-bearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years (Postmenopausal is defined as the time after which a woman has experienced twelve consecutive months of amenorrhea without a period).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of febrile neutropenia (FN) in the first cycle of chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Incidence of febrile neutropenia in cycles 2, 3 and 4 and across all cycles 2. Duration and incidence of severe neutropenia, defined as grade 4 neutropenia with an ANC <0.5 x 10*9/L in cycles 1, 2, 3 and 4 3. Duration and incidence of very severe neutropenia, defined as ANC <0.1 x 10*9/L in cycles 1, 2, 3 and 4 4. Depth of ANC nadir in all cycles 5. Time to ANC nadir in cycles 1, 2, 3 and 4 6. Time to ANC recovery in all cycles 7. Percentage of actually delivered vs. scheduled cumulative chemotherapy dose 8. Proportion of patients with chemotherapy doses reduced, omitted, or delayed 9. Number of days of delay of chemotherapy 10. Overall quality of life as measured by the EORTC QLQ-C30 (version 3) and the EORTC QLQ-LC13 11. Time in hospital and time in intensive care unit due to febrile neutropenia or connected infections 12. Incidence of treatment with i.v. antibiotics due to FN or connected infections 13. Incidence of patients requiring prophylactic open treatment | — |
Countries
Belarus, Bosnia and Herzegovina, Bulgaria, Poland, Romania, Russian Federation, Serbia, Ukraine
Outcome results
None listed