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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004104-33-DE

Enrollment

730

Registered

2016-05-19

Start date

2016-09-13

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced/Recurrent Non Squamous Non-Small Cell Lung Cancer MedDRA version: 20.0 Level: HLT Classification code 10029664 Term: Non-small cell neoplasms malignant of the respiratory tract cell type specified System Organ Class: 100000004864

Interventions

Product Code: FKB238 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: BEVACIZUMAB CAS Number: 216974-75-3

Eligibility

Sex/Gender

All

Inclusion 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

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 active ingredients or 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the efficacy equivalence of FKB238 and EU-Avastin when used in combination with paclitaxel/carboplatin as measured by ORR; Secondary Objective: To compare FKB238 and EU-Avastin through: - Overall response rate at week 19 - 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 ;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]) ;Timepoint(s) of evaluation of this end point: From randomisation to study treatment discontinuation	—

Measure

Time frame

Main Objective: To demonstrate the efficacy equivalence of FKB238 and EU-Avastin when used in combination with paclitaxel/carboplatin as measured by ORR; Secondary Objective: To compare FKB238 and EU-Avastin through: - Overall response rate at week 19 - 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 ;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]) ;Timepoint(s) of evaluation of this end point: From randomisation to study treatment discontinuation

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Secondary

Measure	Time frame
Secondary end point(s): • Overall response rate (ORR) (by RECIST v1.1) at week 19, defined as the rate of the best response of Complete Response (CR) or Partial Response (PR) assessed at week 19 • 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 r	—

Measure

Time frame

Secondary end point(s): • Overall response rate (ORR) (by RECIST v1.1) at week 19, defined as the rate of the best response of Complete Response (CR) or Partial Response (PR) assessed at week 19 • 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 r

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Countries

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

Public ContactClinical Trial Information

Centus Biotherapeutics Limited

Clinical-Trial@centusbio.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026