Efficacy and Safety Study of ABP 215 Compared With Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer

NCT01966003 | Completed Phase 3 Results DMC

• 2 other identifiers: 201202652013-000738-36
• Study Type: interventional
• Target: 642
• Locations: 3 countries
• Sites: 4

Brief Summary

The purpose of this research study is to compare the effectiveness and safety of ABP 215 against bevacizumab in men and women with advanced non-small cell lung cancer.

Conditions

Non-small Cell Lung Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With an Objective Response

  Tumor assessments were performed by central, independent, blinded radiologists according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 using computed tomography (CT) or magnetic resonance imaging (MRI) scans of the chest and abdomen. Objective response is defined as a best overall response of partial response (PR) or complete response (CR) as defined by RECIST v1.1. All participants who did not meet the criteria for CR or PR by the end of the study were considered non-responders. CR: Disappearance of all target and non-target lesions and no new lesions. Any pathological lymph nodes must be reduced in short axis to \< 10 mm. PR: Disappearance of all target lesions with persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits, and no new lesions, or, at least a 30% decrease in the sum of diameters of target lesions, with no progression of existing non-target lesions and no new lesions.

  Disease assessments were performed at weeks 1, 7, 13, 19, and approximately every 9 weeks thereafter. The mean actual follow-up time from randomization was 4.7 and 5.0 months for ABP 215 and bevacizumab, respectively.

Secondary Outcomes (5)

• Duration of Response

  Disease assessments were performed at weeks 1, 7, 13, 19, and approximately every 9 weeks thereafter. The mean actual follow-up time from randomization was 4.7 and 5.0 months for ABP 215 and bevacizumab, respectively.

• Progression-free Survival

  From randomization until the end of study; The mean actual follow-up time from randomization was 4.7 and 5.0 months for ABP 215 and bevacizumab, respectively.

• Number of Participants With Adverse Events

  up to 19 weeks

• Number of Participants Who Developed Anti-drug Antibodies

  44 weeks (6 months after end of treatment)

• Overall Survival

  From randomization until the end of study; The mean actual follow-up time from randomization was 4.7 and 5.0 months for ABP 215 and bevacizumab, respectively.

Study Arms (2)

ABP 215

EXPERIMENTAL

Participants received 15 mg/kg ABP 215 administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.

Drug: Carboplatin; Drug: Paclitaxel; Drug: ABP 215

Bevacizumab

ACTIVE COMPARATOR

Participants received bevacizumab 15 mg/kg administered as an intravenous (IV) infusion every 3 weeks (Q3W) for 6 cycles and carboplatin and paclitaxel chemotherapy Q3W for at least 4 and not more than 6 cycles.

Drug: Carboplatin; Drug: Paclitaxel; Drug: Bevacizumab

Interventions

Carboplatin DRUG

Administered at an area under the concentration-time curve (AUC) 6 by IV infusion Q3W

Also known as: Paraplatin

ABP 215; Bevacizumab

Paclitaxel DRUG

Administered 200 mg/m² IV Q3W

Also known as: Taxol

ABP 215; Bevacizumab

ABP 215 DRUG

Administered 15 mg/kg Q3W by IV infusion

ABP 215

Bevacizumab DRUG

Administered 15 mg/kg Q3W by IV infusion

Also known as: Avastin

Bevacizumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC)
• Subjects must be initiating first-line carboplatin/paclitaxel chemotherapy within 8 days after randomization and expected to receive at least 4 cycles of chemotherapy
• Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1

You may not qualify if:

• 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
• Known to be positive for hepatitis B surface antigen (HbsAg), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
• Life expectancy \< 6 months
• Woman of child-bearing potential who is pregnant or is breast feeding or 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
• Subject has known sensitivity to any of the products to be administered during the study, including mammalian cell derived drug products

Sponsors & Collaborators

• Amgen: lead
• Actavis Inc.: collaborator

Study Sites (4)

Research Site

Bismarck, North Dakota, 58501, United States

Location

Research Site

Fremantle, Western Australia, 6160, Australia

Location

Research Site

Veliko Tarnovo, Veliko Tarnovo, 5000, Bulgaria

Location

Research Site

Rousse, 7003, Bulgaria

Location

Related Publications (1)

• Thatcher N, Goldschmidt JH, Thomas M, Schenker M, Pan Z, Paz-Ares Rodriguez L, Breder V, Ostoros G, Hanes V. Efficacy and Safety of the Biosimilar ABP 215 Compared with Bevacizumab in Patients with Advanced Nonsquamous Non-small Cell Lung Cancer (MAPLE): A Randomized, Double-blind, Phase III Study. Clin Cancer Res. 2019 Apr 1;25(7):2088-2095. doi: 10.1158/1078-0432.CCR-18-2702. Epub 2019 Jan 7.

  PMID: 30617139 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Interventions

Carboplatin; Paclitaxel; Bevacizumab

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2013
• First Posted: October 21, 2013
• Study Start: November 11, 2013
• Primary Completion: July 23, 2015
• Study Completion: July 23, 2015
• Last Updated: October 19, 2017
• Results First Posted: October 19, 2017

Record last verified: 2017-09

Locations

BU (2); AU (1); US (1)