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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-15

Study Completion Date

2022-11-13

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).

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Subjects, Amgen, designated PAREXEL, and other clinical site staff will be blinded to the investigational product allocation for each subject.

Study Groups

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ABP 215

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.

Group Type EXPERIMENTAL

ABP 215

Intervention Type DRUG

ABP 215 will be administered at a dose of 15 mg/kg IV

Paclitaxel

Intervention Type DRUG

Paclitaxel will be administered 175 mg/m2 IV

Carboplatin

Intervention Type DRUG

Carboplatin will be administered at an area under the concentration-time curve (AUC) of 5 IV

Bevacizumab

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.

Group Type ACTIVE_COMPARATOR

Bevacizumab

Intervention Type DRUG

Bevacizumab will be administered at a dose of 15 mg/kg IV

Paclitaxel

Intervention Type DRUG

Paclitaxel will be administered 175 mg/m2 IV

Carboplatin

Intervention Type DRUG

Carboplatin will be administered at an area under the concentration-time curve (AUC) of 5 IV

Interventions

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ABP 215

ABP 215 will be administered at a dose of 15 mg/kg IV

Intervention Type DRUG

Bevacizumab

Bevacizumab will be administered at a dose of 15 mg/kg IV

Intervention Type DRUG

Paclitaxel

Paclitaxel will be administered 175 mg/m2 IV

Intervention Type DRUG

Carboplatin

Carboplatin will be administered at an area under the concentration-time curve (AUC) of 5 IV

Intervention Type DRUG

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.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No