Phase 3
Completed N=642
Efficacy and Safety Study of ABP 215 Compared With Bevacizumab in Patients With Advanced Non-Small Cell Lung Cancer
Non-small Cell Lung Cancer Metastatic
Source: ClinicalTrials.gov NCT01966003 ↗
Enrolled (actual)
642
Serious AEs
24.6%
Results posted
Oct 2017
Primary outcomePrimary: Percentage of Participants With an Objective Response — 39.0; 41.7 percentage of participants
◆ Published Evidence
Established
67citations · ~10 / year
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.
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.
Linked Publications
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an Objective Response |
39.0; 41.7 | — |
| SECONDARY Duration of Response |
5.8; 5.6 | — |
| SECONDARY Progression-free Survival |
6.6; 7.9 | — |
| SECONDARY Number of Participants With Adverse Events |
308; 289; 139; 137; 13; 11 | — |
| SECONDARY Number of Participants Who Developed Anti-drug Antibodies |
4; 7; 0; 0 | — |
| SECONDARY Overall Survival |
NA; NA | — |
Eligibility Criteria
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
- Other inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01966003) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.