Evaluation of FKB238 and Avastin® in patients with advanced/recurrent non-squamous non-small cell lung cancer

• Register: EUCTR
• Last refreshed on: 2 March 2022
• Main ID: EUCTR2015-004104-33-HU
• Date of registration: 23/05/2016
• Prospective Registration: Yes
• Primary sponsor: Centus Biotherapeutics Limited
• Public title: Evaluation of FKB238 and Avastin® in patients with advanced/recurrent non-squamous non-small cell lung cancer
• Scientific title: A Randomised, Parallel, Double Blinded Study to Compare the Efficacy and Safety of FKB238 to Avastin® In 1st Line Treatment for Patients with Advanced/Recurrent Non Squamous Non-Small Cell Lung Cancer in Combination of Paclitaxel and Carboplatin - AVANA
• Date of first enrolment: 13/07/2016
• Target sample size: 730
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-004104-33
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no; Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Belarus, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Croatia, France, Georgia, Germany, Greece, Hungary, Italy, Japan, Korea, Republic of, Peru, Philippines, Poland, Romania, Russian Federation, Serbia, Spain, Taiwan, Thailand, Turkey, Ukraine, United States, Vietnam

Contacts

• Name: Clinical Trial Information
• Affiliation: Centus Biotherapeutics Limited

• Name: Clinical Trial Information
• Affiliation: Centus Biotherapeutics Limited

Key inclusion & exclusion criteria

Inclusion criteria:
• Patients aged 18 years or older
• Newly diagnosed advanced (stage IV) /recurrent non-squamous NSCLC for which they had not received any systemic anti-cancer therapy for metastatic disease
• Histologically or cytologically confirmed diagnosis of predominantly non-squamous NSCLC
• Existence of at least 1 measurable lesion by response evaluation criteria
• Adequate haematological, renal and liver function

Other inclusion criteria may apply.
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 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 130

Exclusion criteria:
• Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumours and mixed adenosquamous carcinomas of predominantly squamous nature
• Any unresolved toxicities from prior systemic therapy
• Known sensitising EGFR mutations or EML4-ALK translocation positive mutations
• Previous dosing with vascular endothelial growth factor (VEGF) inhibitor
• Known hypersensitivity to any excipients of the IPs and combination chemotherapy
• Use of prohibited concomitant medication
• Known Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV) infection
• Fertile men or women of childbearing potential not using adequate contraception

Other exclusion criteria may apply.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

Advanced/Recurrent Non Squamous Non-Small Cell Lung Cancer
MedDRA version: 19.0 Level: HLT Classification code 10029664 Term: Non-small cell neoplasms malignant of the respiratory tract cell type specified System Organ Class: 100000004864

Intervention(s)

Product Code: FKB238
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: BEVACIZUMAB
CAS Number: 216974-75-3
Current Sponsor code: FKB238
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-

Trade Name: Avastin
Product Name: Avastin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: BEVACIZUMAB
CAS Number: 216974-75-3
Other descriptive name: Avastin
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 25-

Primary Outcome(s)

Primary end point(s): Overall Response Rate (by Response Evaluation Criteria [RECIST] v1.1) assessed as the rate of the best response (complete response [CR] or partial response [PR])

Secondary Objective: To compare FKB238 and EU-Avastin through:
- Progression-free Survival
- Overall Survival
- Duration Of Response
- Disease Control Rate
To compare the safety of FKB238 and EU-Avastin
To compare the ADAs produced by FKB238 and EU-Avastin
To compare the serum trough concentration (Ctrough) of FKB238 and EU-Avastin

Timepoint(s) of evaluation of this end point: From randomisation to study treatment discontinuation

Main Objective: To demonstrate the efficacy equivalence of FKB238 and EU-Avastin when used in combination with paclitaxel/carboplatin as measured by ORR

Secondary Outcome(s)

Secondary end point(s): • Progression-free Survival (PFS), defined as the time from randomisation to the first documented disease progression (PD) or death, whichever occurs first
• Overall Survival (OS), defined as the time from randomisation to death from any cause
• Duration Of Response (DOR), defined as the time from the first documented Partial Response (PR) or Complete Response (CR) (by RECIST v1.1) to the first documented objective PD or death, whichever occurs first
• Disease Control Rate (DCR), defined as the rate of CR, PR, Stable Disease (SD) (=6 weeks)
• Safety as evaluated through Adverse Events (AEs), vital signs, haematology, clinical chemistry, urinalysis, electrocardiogram (ECG), Eastern Collaborative Oncology Group Performance Status (ECOG PS), and physical examination
• Immunogenicity (presence of ADAs)
• Pharmacokinetics (PK) (Ctrough)

Timepoint(s) of evaluation of this end point: • PFS: from randomisation to the first documented disease progression (PD), death or data cut-off, whichever occurs first
• OS: from randomisation to death from any cause or data cut-off
• DOR: from the first documented Partial Response (PR) or Complete Response (CR) (by RECIST v1.1) to the first documented objective PD or death, whichever occurs first
• DCR: the rate of CR, PR, Stable Disease (SD) (=6 weeks)
• Safety: from signature of informed consent, up to and including 30-day follow-up after last dose of study treatment
• Immunogenicity: from randomisation to the end of follow-up period, death, lost to follow-up or data cut-off, whichever occurs first
• PK: from randomisation to the end of follow-up period, death, lost to follow-up or data cut-off, whichever occurs first

Secondary ID(s)

122990

2015-004104-33-DE

FKB238-002

Source(s) of Monetary Support

Centus Biotherapeutics Limited

Ethics review

Status: Approved
Approval date: 30/06/2016
Contact:

Results

• Results available: Yes
• Date Posted: 09/02/2020
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2015-004104-33/results