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

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
Study Start Date :	June 2016
Estimated Primary Completion Date :	June 2019
Estimated Study Completion Date :	June 2019

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, 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  Show 157 Study Locations

Sponsors and Collaborators

Centus Biotherapeutics Limited

Investigators

Study Director:	Centus Biotherapeutics Limited	Centus Biotherapeutics Limited

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 )
First Posted:	June 23, 2016
Last Update Posted:	February 5, 2018
Last Verified:	February 2018

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