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Efficacy and Safety Study of ABP 215 Compared With Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Randomized, Double-blind, Phase 3 Study Evaluating the Efficacy and Safety of ABP 215 Compared With Bevacizumab in Subjects With Advanced Non-Small Cell Lung Cancer

NCT01966003•Amgen

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

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
•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

Locations (4)

Research Site

Bismarck, North Dakota, United States

Research Site

Fremantle, Western Australia, Australia

Research Site

Veliko Tarnovo, Veliko Tarnovo, Bulgaria

Research Site

Rousse, Bulgaria

Key Dates

Start Date

November 11, 2013

Primary Completion Date

July 23, 2015

Completion Date

July 23, 2015

Last Updated

October 19, 2017

Enrollment

642

ACTUAL participants

Conditions

Non-small Cell Lung Cancer Metastatic

Interventions

Carboplatin

DRUG

Paclitaxel

DRUG

ABP 215

DRUG

Bevacizumab

DRUG

Risk-adapted, Proteomic-guided Systemic Therapy for Previously Untreated Advanced Non-small Cell Lung Cancer

NCT07250477

Non-small Cell Lung Cancer Stage IIICNon-small Cell Lung Cancer Stage IV+3 more

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RECRUITINGPHASE2

Befotertinib and Icotinib for NSCLC With Uncommon EGFR Mutations

NCT06517953

Non-small Cell Lung Cancer MetastaticEGFR G719X+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 19, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Risk-adapted, Proteomic-guided Systemic Therapy for Previously Untreated Advanced Non-small Cell Lung Cancer

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