A Safety and Efficacy Study of Farletuzumab in Participants With Adenocarcinoma of the Lung
The primary objective of this study is to compare the effect of farletuzumab versus placebo in combination with either a platinum agent (carboplatin) with paclitaxel or a platinum agent (carboplatin or cisplatin) with pemetrexed followed by farletuzumab or placebo on investigator-assessed progression free survival (PFS) as determined by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 or definitive clinical disease progression (eg, new occurrence of positive fluid cytology) in chemotherapy naive participants with folate receptoralpha (FRA)-expressing Stage IV adenocarcinoma of the lung.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 4 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Aug 20, 2020 · Source: ClinicalTrials.gov
Ask the study team to confirm whether enrollment is open.
Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 2
- Sponsor
- Morphotek
- Interventions being studied
- Biological: Farletuzumab; Other: Placebo; Drug: Carboplatin; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Cisplatin
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Histologically or cytologically confirmed adenocarcinoma of the lung classified as stage IV
- Confirmed folate receptor-alpha (FRA) expression by immunohistochemistry (IHC)
- Measurable disease with at least one unidimensionally measurable lesion according to RECIST criteria version 1.1 by computed tomography (CT) or magnetic resonance imaging (MRI) scans (CT or MRI scans must have been performed within 30 days prior to the first dose of farletuzumab or placebo)
- Must have received no prior chemotherapy, radiation therapy or surgery with curative intent for adenocarcinoma of the lung
- Participants who have had previous chemotherapy for adenocarcinoma of the lung
- Prior surgery with curative intent for adenocarcinoma of the lung
- Prior radiotherapy for adenocarcinoma of the lung. (Prior treatment with local radiotherapy for symptom control \[i.e., palliative radiation with non-curative intent\] is permitted)
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Ironwood Cancer and Research CenterChandler, Arizona
- Arizona Center for Hematology OncologyGlendale, Arizona
- Providence Health SystemBeverly Hills, California
- Cancer Care Associates of Fresno Medical Group, Inc.Fresno, California
- Medical Oncology HematologyGilroy, California
- California Cancer Care, Inc.Greenbrae, California
- Moores University of California San Diego Cancer CenterLa Jolla, California
- Wilshire Medical Oncology GroupLa Verne, California
- Glendale Adventist Medical CenterLos Angeles, California
- Clinical Trials and Research Associates, Inc.Montebello, California
- North Country Oncology-HematologyOceanside, California
- Pacific Hematology Oncology AssociatesSan Francisco, California
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 20, 2020. Always confirm current availability with the study team.