A Study of ABP 215 Versus Bevacizumab in Chinese Subjects... | NCT04466917

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

NCT04466917

Sponsor

Amgen

Status

Withdrawn

Last Update Posted

Jul 3, 2023Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

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

Interventions

ABP 215
Bevacizumab
Paclitaxel
Carboplatin

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor decision to early terminate the study

Expanded Access Info

Start Date

May 15, 2021Estimated

Primary Completion Date

Nov 13, 2022Estimated

Completion Date

Nov 13, 2022Estimated

First Submitted Date

Jul 7, 2020

First Submission Date that Met QC Criteria

Jul 7, 2020

First Posted Date

Jul 10, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 28, 2023

Last Update Posted Date

Jul 3, 2023Actual

Name	Class
Parexel	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ABP 215	Experimental	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 Drug: Paclitaxel Drug: Carboplatin
Bevacizumab	Active Comparator	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 Drug: Paclitaxel Drug: Carboplatin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ABP 215	Drug	ABP 215 will be administered at a dose of 15 mg/kg IV	ABP 215

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
MD	Amgen	Study Director

Label	URL
AmgenTrials clinical trials website	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068258	Bevacizumab
D017239	Paclitaxel
D016190	Carboplatin

Ancestor Terms

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins

Browse Leaves

Not provided

Browse Branches

Not provided