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

June 28, 2023 updated by: Amgen

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

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: ABP 215
ABP 215 will be administered at a dose of 15 mg/kg IV
Drug: Paclitaxel
Paclitaxel will be administered 175 mg/m2 IV
Drug: Carboplatin
Carboplatin will be administered at an area under the concentration-time curve (AUC) of 5 IV
Active Comparator: 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.
Drug: Paclitaxel
Paclitaxel will be administered 175 mg/m2 IV
Drug: Carboplatin
Carboplatin will be administered at an area under the concentration-time curve (AUC) of 5 IV
Drug: Bevacizumab
Bevacizumab will be administered at a dose of 15 mg/kg IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR)
Time Frame: From Day 1 to Week 19 (EOS)
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
Time Frame
Progression-free survival (PFS)
Time Frame: From Day 1 to Week 19 (EOS)
From Day 1 to Week 19 (EOS)
Duration of response (DOR)
Time Frame: From Day 1 to Week 19 (EOS)
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)
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)
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)
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)
From Screening to Week 19 (EOS)
Number of participants with treatment-emergent events of interest (EOIs)
Time Frame: From Screening to Week 19 (EOS)
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)
On Week 1, Week 7, Week 13 and Week 19 (EOS)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Collaborators

Parexel

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2021

Primary Completion (Estimated)

November 13, 2022

Study Completion (Estimated)

November 13, 2022

Study Registration Dates

First Submitted

July 7, 2020

First Submitted That Met QC Criteria

July 7, 2020

First Posted (Actual)

July 10, 2020

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 28, 2023

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20180085

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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