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

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ClinicalTrials.gov Identifier: NCT02810457
Recruitment Status : Active, not recruiting
First Posted : June 23, 2016
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Centus Biotherapeutics Limited

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: FKB238 (bevacizumab) Drug: Avastin (bevacizumab) Drug: Paclitaxel Drug: Carboplatin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 731 participants
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
Actual Study Start Date : September 7, 2016
Actual Primary Completion Date : January 24, 2019
Estimated Study Completion Date : February 2022

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 :
  1. Progression-free Survival [ Time Frame: Up to approximately 12 months after randomisation of the last patient enrolled ]
  2. Overall Survival [ Time Frame: Up to approximately 12 months after randomisation of the last patient enrolled ]
  3. Duration Of Response [ Time Frame: Up to approximately 12 months after randomisation of the last patient enrolled ]
  4. 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:
  1. Adverse events (AEs) [ Time Frame: Up to approximately 30 days after last dose of study treatment ]
  2. Vital signs [ Time Frame: Up to approximately 30 days after last dose of study treatment ]
  3. Hematology [ Time Frame: Up to approximately 30 days after last dose of study treatment ]
  4. Clinical chemistry [ Time Frame: Up to approximately 30 days after last dose of study treatment ]
  5. Urinalysis [ Time Frame: Up to approximately 30 days after last dose of study treatment ]
  6. Electrocardiogram [ Time Frame: Up to approximately 30 days after last dose of study treatment ]
  7. Eastern Collaborative Oncology Group Performance Status [ Time Frame: Up to approximately 30 days after last dose of study treatment ]
  8. Physical examination [ Time Frame: Up to approximately 30 days after last dose of study treatment ]
  9. Proportion of patients developing Anti-drug antibodies (ADAs) [ Time Frame: Up to approximately 12 months after randomisation of the last patient enrolled ]
  10. Serum trough concentration [ Time Frame: Up to approximately 12 months after randomisation of the last patient enrolled ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02810457


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Sponsors and Collaborators
Centus Biotherapeutics Limited
Investigators
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Study Director: Centus Biotherapeutics Limited Centus Biotherapeutics Limited
More Information
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Responsible Party: Centus Biotherapeutics Limited
ClinicalTrials.gov Identifier: NCT02810457     History of Changes
Other Study ID Numbers: FKB238-002
2015-004104-33 ( EudraCT Number )
First Posted: June 23, 2016    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019

Keywords provided by Centus Biotherapeutics Limited:
Cancer
Bevacizumab
Carboplatin
Paclitaxel

Additional relevant MeSH terms:
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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
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors