Efficacy and safety of XM22 in patients with non small cell lung cancer receiving cisplatin / etoposide chemotherapy

ISRCTN ISRCTN55761467
DOI https://doi.org/10.1186/ISRCTN55761467
Protocol serial number XM22-04
Sponsor BioGeneriX AG (Germany)
Funder BioGeneriX AG (Germany)
Submission date
22/04/2010
Registration date
10/06/2010
Last edited
16/01/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Peter Bias
Scientific

Merckle GmbH
A Member of the ratiopharm Group
Clinical Research
Graf-Arco-Straße 3
Ulm
89075
Germany

Study information

Primary study designInterventional
Study designMultinational multicentre randomised double blind placebo controlled phase III study
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleEfficacy 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
Study objectivesDemonstration 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(s)At each study centre, the protocol (dated 01/10/2009) 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
Health condition(s) or problem(s) studiedNSCLC patients with chemotherapy induced neutropenia
InterventionXM22: 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 typeDrug
PhasePhase III
Drug / device / biological / vaccine name(s)XM22
Primary outcome measure(s)

Incidence of febrile neutropenia (FN) in the first cycle of chemotherapy

Key secondary outcome measure(s)

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

Completion date01/03/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration375
Key inclusion criteria1. 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
Key exclusion criteria1. 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).
Date of first enrolment01/05/2010
Date of final enrolment01/03/2012

Locations

Countries of recruitment

  • Belarus
  • Bosnia and Herzegovina
  • Bulgaria
  • Germany
  • Poland
  • Romania
  • Russian Federation
  • Serbia
  • Ukraine

Study participating centre

Merckle GmbH
Ulm
89075
Germany

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 03/07/2015 16/01/2019 Yes No
Results article results 01/12/2016 16/01/2019 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes

Editorial Notes

16/01/2019: Publication references added.

BMC - Part of Springer Nature Springer Nature