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

Amgen

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

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

Interventions

ABP 215DRUG

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

BevacizumabDRUG

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

PaclitaxelDRUG

Paclitaxel will be administered 175 mg/m2 IV

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Objective response rate (ORR)

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 Outcomes

Progression-free survival (PFS)

Time frame: From Day 1 to Week 19 (EOS)

Duration of response (DOR)

Time frame: From Day 1 to Week 19 (EOS)

Maximum Plasma Concentration (Cmax)

Time frame: Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS)

Area Under the Curve (AUC)

Time frame: Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS)

Minimum observed concentration (Cmin)

Time frame: Pre-dose on Week 1, Week 4, Week 7, Week 13 and Week 19 (EOS)

Number of participants with treatment-emergent adverse events

Time frame: From Screening to Week 19 (EOS)

Number of participants with treatment-emergent events of interest (EOIs)

Time frame: From Screening to Week 19 (EOS)

Number of participants with incidence of anti-drug antibodies (ADAs)

Time frame: On Week 1, Week 7, Week 13 and Week 19 (EOS)

Data from ClinicalTrials.gov

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