Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
XM22-04
Study information
Scientific title
Efficacy and safety of XM22 in patients with non small cell lung cancer receiving cisplatin / etoposide chemotherapy. A multinational, multicentre, randomised, double-blind placebo-controlled study
Acronym
Study hypothesis
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)
Ethics approval
At each study centre, the protocol (dated 01 October 2009) and informed consent form for this study were reviewed and approved by Independent Ethic Committees before inclusion of patients. Amendments to the protocol will be reviewed and approved in the same manner before being implemented
Study design
Multinational multicentre randomised double blind placebo controlled phase III study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
NSCLC patients with chemotherapy induced neutropenia
Intervention
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 days.
Intervention type
Drug
Phase
Phase III
Drug names
XM22
Primary outcome measure
Incidence of febrile neutropenia (FN) in the first cycle of chemotherapy
Secondary outcome measures
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
Overall trial start date
01/05/2010
Overall trial end date
01/03/2012
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
375 (250 XM22 group, 125 placebo group)
Participant 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).
Recruitment start date
01/05/2010
Recruitment end date
01/03/2012
Locations
Countries of recruitment
Belarus, Bosnia and Herzegovina, Bulgaria, Poland, Romania, Russian Federation, Serbia, Ukraine
Trial participating centre
Merckle GmbH
Ulm
89075
Germany
Sponsor information
Organisation
BioGeneriX AG (Germany)
Sponsor details
High-Tech-Park Neckarau
Janderstraße 3
Mannheim
68199
Germany
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
BioGeneriX AG (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list