Back to resultsA Study of ABP 215 Versus Bevacizumab in Chinese Subjects With Advanced Non-Squamous Non-Small Cell Lung Cancer
Primary Purpose
Metastatic Non-small Cell Lung Cancer (NSCLC), Non-squamous NSCLC
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
ABP 215
Bevacizumab
Paclitaxel
Carboplatin
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Non-small Cell Lung Cancer (NSCLC) focused on measuring Biosimilar, Bevacizumab, Carboplatin, Paclitaxel
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
ABP 215
Bevacizumab
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Objective response rate (ORR)
The percentage of subjects with a best overall tumor response of Complete Response (CR) or Partial Response (PR).
Secondary Outcome Measures
Progression-free survival (PFS)
Duration of response (DOR)
Maximum Plasma Concentration (Cmax)
Area Under the Curve (AUC)
Minimum observed concentration (Cmin)
Number of participants with treatment-emergent adverse events
Number of participants with treatment-emergent events of interest (EOIs)
Number of participants with incidence of anti-drug antibodies (ADAs)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04466917
Brief Title
A Study of ABP 215 Versus Bevacizumab in Chinese Subjects With Advanced Non-Squamous Non-Small Cell Lung Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor decision to early terminate the study
Study Start Date
May 15, 2021 (Anticipated)
Primary Completion Date
November 13, 2022 (Anticipated)
Study Completion Date
November 13, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amgen
Collaborators
Parexel
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Non-small Cell Lung Cancer (NSCLC), Non-squamous NSCLC
Keywords
Biosimilar, Bevacizumab, Carboplatin, Paclitaxel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Subjects, Amgen, designated PAREXEL, and other clinical site staff will be blinded to the investigational product allocation for each subject.
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ABP 215
Arm Type
Experimental
Arm Description
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.
Arm Title
Bevacizumab
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
ABP 215
Intervention Description
ABP 215 will be administered at a dose of 15 mg/kg IV
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
Bevacizumab will be administered at a dose of 15 mg/kg IV
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel will be administered 175 mg/m2 IV
Intervention Type
Drug
Intervention Name(s)
Carboplatin
Intervention Description
Carboplatin will be administered at an area under the concentration-time curve (AUC) of 5 IV
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
The percentage of subjects with a best overall tumor response of Complete Response (CR) or Partial Response (PR).
Time Frame
From Day 1 to Week 19 (EOS)
Secondary Outcome Measure Information:
Title
Progression-free survival (PFS)
Time Frame
From Day 1 to Week 19 (EOS)
Title
Duration of response (DOR)
Time Frame
From Day 1 to Week 19 (EOS)
Title
Maximum Plasma Concentration (Cmax)
Time Frame
Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS)
Title
Area Under the Curve (AUC)
Time Frame
Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS)
Title
Minimum observed concentration (Cmin)
Time Frame
Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS)
Title
Number of participants with treatment-emergent adverse events
Time Frame
From Screening to Week 19 (EOS)
Title
Number of participants with treatment-emergent events of interest (EOIs)
Time Frame
From Screening to Week 19 (EOS)
Title
Number of participants with incidence of anti-drug antibodies (ADAs)
Time Frame
On Week 1, Week 7, Week 13 and Week 19 (EOS)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MD
Organizational Affiliation
Amgen
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.amgentrials.com
Description
AmgenTrials clinical trials website
Learn more about this trial
A Study of ABP 215 Versus Bevacizumab in Chinese Subjects With Advanced Non-Squamous Non-Small Cell Lung Cancer
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