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Trial record 1 of 1 for:    Centus
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Evaluation of FKB238 and Avastin in Patients With Advanced/Recurrent Non-squamous Non-small Cell Lung Cancer (AVANA)

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Centus Biotherapeutics Limited
Sponsor:
Information provided by (Responsible Party):
Centus Biotherapeutics Limited
ClinicalTrials.gov Identifier:
NCT02810457
First received: June 3, 2016
Last updated: July 21, 2017
Last verified: July 2017
  Purpose
The purpose of this research study is to compare the effectiveness and safety of FKB238 against Avastin® in men and women with advanced/recurrent non squamous non-small cell lung cancer

Condition Intervention Phase
Carcinoma, Non-Small-Cell Lung Drug: FKB238 (bevacizumab) Drug: Avastin (bevacizumab) Drug: Paclitaxel Drug: Carboplatin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Centus Biotherapeutics Limited:

Primary Outcome Measures:
  • Overall Response Rate (ORR) assessed as the proportion of subjects with a best overall response (BOR) of either Complete Response (CR) or Partial Response (PR) [ Time Frame: Up to approximately 12 months after randomisation of the last patient enrolled ]

Secondary Outcome Measures:
  • Progression-free Survival [ Time Frame: Up to approximately 12 months after randomisation of the last patient enrolled ]
  • Overall Survival [ Time Frame: Up to approximately 12 months after randomisation of the last patient enrolled ]
  • Duration Of Response [ Time Frame: Up to approximately 12 months after randomisation of the last patient enrolled ]
  • Disease Control Rate (DCR) assessed as the proportion of subjects with a best overall response (BOR) of either Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [ Time Frame: Up to approximately 12 months after randomisation of the last patient enrolled ]

Other Outcome Measures:
  • Adverse events (AEs) [ Time Frame: Up to approximately 30 days after last dose of study treatment ]
  • Vital signs [ Time Frame: Up to approximately 30 days after last dose of study treatment ]
  • Hematology [ Time Frame: Up to approximately 30 days after last dose of study treatment ]
  • Clinical chemistry [ Time Frame: Up to approximately 30 days after last dose of study treatment ]
  • Urinalysis [ Time Frame: Up to approximately 30 days after last dose of study treatment ]
  • Electrocardiogram [ Time Frame: Up to approximately 30 days after last dose of study treatment ]
  • Eastern Collaborative Oncology Group Performance Status [ Time Frame: Up to approximately 30 days after last dose of study treatment ]
  • Physical examination [ Time Frame: Up to approximately 30 days after last dose of study treatment ]
  • Proportion of patients developing Anti-drug antibodies (ADAs) [ Time Frame: Up to approximately 12 months after randomisation of the last patient enrolled ]
  • Serum trough concentration [ Time Frame: Up to approximately 12 months after randomisation of the last patient enrolled ]

Estimated Enrollment: 730
Study Start Date: June 2016
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FKB238 / paclitaxel / carboplatin
Drug: FKB238 15 mg/kg IV infusion on Day 1 of a 21-day cycle Drug: Paclitaxel 200 mg/m2 IV infusion on Day 1 of a 21-day cycle for each of at least 4 and no more than 6 cycles Drug: Carboplatin Area Under Curve (AUC) = 6.0 IV infusion on Day 1 of a 21-day cycle for each of at least 4 and no more than 6 cycles
Drug: FKB238 (bevacizumab) Drug: Paclitaxel Drug: Carboplatin
Active Comparator: Avastin / paclitaxel / carboplatin
Drug: Avastin 15 mg/kg IV infusion on Day 1 of a 21-day cycle Drug: Paclitaxel 200 mg/m2 IV infusion on Day 1 of a 21-day cycle for each of at least 4 and no more than 6 cycles Drug: Carboplatin AUC = 6.0 IV infusion on Day 1 of a 21-day cycle for each of at least 4 and no more than 6 cycles
Drug: Avastin (bevacizumab) Drug: Paclitaxel Drug: Carboplatin

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 EGFR mutations or 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02810457

Contacts
Contact: Clinical Trial Information Clinical-Trials@centusbio.com

  Show 182 Study Locations
Sponsors and Collaborators
Centus Biotherapeutics Limited
Investigators
Study Director: Centus Biotherapeutics Limited Centus Biotherapeutics Limited
  More Information

Responsible Party: Centus Biotherapeutics Limited
ClinicalTrials.gov Identifier: NCT02810457     History of Changes
Other Study ID Numbers: FKB238-002
2015-004104-33 ( EudraCT Number )
Study First Received: June 3, 2016
Last Updated: July 21, 2017

Keywords provided by Centus Biotherapeutics Limited:
Cancer
Bevacizumab
Carboplatin
Paclitaxel

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Bevacizumab
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on August 18, 2017