A Study of ABP 215 Versus Bevacizumab in Chinese Subjects With Advanced Non-Squamous Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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The purpose of this research study is to assess the efficacy and safety of ABP 215 compared to Bevacizumab in Chinese patients with advanced non-small cell lung cancer (NSCLC).

Detailed Description
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Approximately 170 subjects will be randomized 1:1 in approximately 40 sites in China. This study consists of a screening period of up to 28 days, followed by a treatment period of 18 weeks, and an end of study visit 3 weeks after the last dose of investigational product or study-specified chemotherapy. After randomization, subjects will receive investigational product at a dose of 15 mg/kg administered every 3 weeks for 6 cycles followed by at least 4 and no more than 6 cycles of carboplatin and paclitaxel chemotherapy every 3 weeks.

Official Title
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A Randomized, Double-blind, Phase 3 Bridging Study Evaluating the Safety and Efficacy of ABP 215 Compared With Bevacizumab in Chinese Subjects With Advanced Non-Squamous Non-Small Cell Lung Cancer

Conditions
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Metastatic Non-small Cell Lung Cancer (NSCLC), Non-squamous NSCLC

Intervention / Treatment
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* Drug: ABP 215
* Drug: Bevacizumab
* Drug: Paclitaxel
* Drug: Carboplatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically confirmed non-squamous NSCLC. Subjects must be initiating first-line carboplatin/paclitaxel chemotherapy within 8 days after randomization and expected to receive at least 4 and no more than 6 cycles of chemotherapy. Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1. Other inclusion criteria may apply. Exclusion Criteria: Small cell lung cancer (SCLC) or mixed SCLC and NSCLC. Central nervous system (CNS) metastases. Malignancy other than NSCLC. Palliative radiotherapy for bone lesions inside the thorax. Prior radiotherapy of bone marrow. Active hepatitis B. Active hepatitis C. Tested positive for human immunodeficiency virus (HIV). Life expectancy < 6 months. Woman of childbearing potential who is pregnant or is breast feeding. Woman of childbearing potential who is not consenting to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment. Man with a partner of childbearing potential who does not consent to use highly effective methods of birth control during treatment and for an additional 6 months after the last administration of the protocol specified treatment. Other exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Subjects will be randomized to receive ABP 215 or bevacizumab on a 1:1 basis. All subjects will receive chemotherapy, following administration of investigational product.
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABP 215<br>Subjects will be randomized to receive ABP 215 every 3 weeks (Q3W) for 6 cycles. All subjects will receive carboplatin and paclitaxel after the ABP 215 IV infusion every Q3W for at least 4 and not more than for 6 cycles. | Drug: ABP 215<br>* ABP 215 will be administered at a dose of 15 mg/kg IV<br>Drug: Paclitaxel<br>* Paclitaxel will be administered 175 mg/m2 IV<br>Drug: Carboplatin<br>* Carboplatin will be administered at an area under the concentration-time curve (AUC) of 5 IV<br>|
| Active Comparator: Bevacizumab<br>Subjects will be randomized to receive Bevacizumab every 3 weeks (Q3W) for 6 cycles. All subjects will receive carboplatin and paclitaxel after the Bevacizumab IV infusion every Q3W for at least 4 and not more than for 6 cycles. | Drug: Bevacizumab<br>* Bevacizumab will be administered at a dose of 15 mg/kg IV<br>Drug: Paclitaxel<br>* Paclitaxel will be administered 175 mg/m2 IV<br>Drug: Carboplatin<br>* Carboplatin will be administered at an area under the concentration-time curve (AUC) of 5 IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | The percentage of subjects with a best overall tumor response of Complete Response (CR) or Partial Response (PR). | From Day 1 to Week 19 (EOS) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival (PFS) |  | From Day 1 to Week 19 (EOS) | 
| Duration of response (DOR) |  | From Day 1 to Week 19 (EOS) | 
| Maximum Plasma Concentration (Cmax) |  | Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS) | 
| Area Under the Curve (AUC) |  | Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS) | 
| Minimum observed concentration (Cmin) |  | Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS) | 
| Number of participants with treatment-emergent adverse events |  | From Screening to Week 19 (EOS) | 
| Number of participants with treatment-emergent events of interest (EOIs) |  | From Screening to Week 19 (EOS) | 
| Number of participants with incidence of anti-drug antibodies (ADAs) |  | On Week 1, Week 7, Week 13 and Week 19 (EOS) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Biosimilar, Bevacizumab, Carboplatin, Paclitaxel