Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer

• Register: ClinicalTrials.gov
• Last refreshed on: 10 August 2021
• Main ID: NCT02810457
• Date of registration: 03/06/2016
• 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 AVANA
• 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 NSCLC in Combination of Paclitaxel and Carboplatin
• Date of first enrolment: September 7, 2016
• Target sample size: 731
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02810457
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Belarus, Bosnia and Herzegovina, Bulgaria, Canada, Croatia, 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: Centus Biotherapeutics Limited
• 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 RECIST v1.1

- Adequate hematological, renal and liver function

- Eastern Collaborative Oncology Group Performance Status (ECOG PS) 0 or 1

- Life expectancy longer than 6 months

Exclusion Criteria:

- Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and
mixed adenosquamous carcinomas of predominantly squamous nature

- Any unresolved toxicities from prior systemic therapy

- Known sensitizing epidermal growth factor receptor (EGFR) mutations or echinoderm
microtubule-associated protein-like 4-anaplastic lymphoma kinase (EML4-ALK)
translocation positive mutations

- Previous dosing with vascular endothelial growth factor (VEGF) inhibitor

- Known hypersensitivity to any excipients of the Investigational Products (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 inclusion/exclusion criteria may apply.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Carcinoma, Non-Small-Cell Lung

Intervention(s)

Drug: Carboplatin

Drug: FKB238 (bevacizumab)

Drug: Paclitaxel

Drug: Avastin (bevacizumab)

Primary Outcome(s)

Overall Response Rate (ORR) Assessed as the Proportion of Patients With a Best Overall Response (BOR) of Either Complete Response (CR) or Partial Response (PR) [Time Frame: Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.]

Secondary Outcome(s)

Duration Of Response (DOR) [Time Frame: Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.]

Progression-free Survival (PFS) [Time Frame: Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.]

Disease Control Rate (DCR) Assessed as the Proportion of Patients With a BOR of Either CR, PR, SD or NED [Time Frame: Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.]

Overall Survival (OS) [Time Frame: Until data cut-off, which occurred 12 months after randomization of the last patient enrolled, for a total estimated period of time of up to approximately 30 months.]

ORR at Week 19 [Time Frame: From the date of randomization up to Week 19.]

Secondary ID(s)

2015-004104-33

FKB238-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/03/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02810457