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

NCT04466917 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: 20180085
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

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

Keywords

Biosimilar; Bevacizumab; Carboplatin; Paclitaxel

Outcome Measures

Primary Outcomes (1)

• 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 (8)

• 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)

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

• Area Under the Curve (AUC)

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

• Minimum observed concentration (Cmin)

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

Study Arms (2)

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

ABP 215 DRUG

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

ABP 215

Bevacizumab DRUG

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

Bevacizumab

Paclitaxel DRUG

Paclitaxel will be administered 175 mg/m2 IV

ABP 215; Bevacizumab

Carboplatin DRUG

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

ABP 215; 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 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.

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.
• 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.

Sponsors & Collaborators

• Amgen: lead
• Parexel: collaborator

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Bevacizumab; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects, Amgen, designated PAREXEL, and other clinical site staff will be blinded to the investigational product allocation for each subject.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 10, 2020
• Study Start: May 15, 2021
• Primary Completion: November 13, 2022
• Study Completion: November 13, 2022
• Last Updated: July 3, 2023

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share