A Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Participants With Advanced Carcinoma
The purpose of the study was to determine whether the combination of aflibercept, pemetrexed and cisplatin is safe and effective in treating non-small cell lung cancer (NSCLC).
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 1 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Dec 10, 2020 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Regeneron Pharmaceuticals
- Interventions being studied
- Drug: Aflibercept; 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.
- Confirmation of cancer by biopsy (tissue sample)
- Phase 1: patients with advanced or metastatic disease that have failed conventional therapy
- Phase 2: patients with previously untreated NSCLC, excluding squamous cell histology and cavitating lesions
- Age ≥18 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Adequate renal, liver and bone marrow function.
- Negative pregnancy test (serum or urine) in females of childbearing potential within 7 days of the initial dose of aflibercept
- Ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- Institutional Review Board (IRB) approved, signed and dated informed consent form
- Prior treatment with study medications
- Untreated, symptomatic, or progressive Central Nervous System cancer and/or spinal cord compression. Patients with treated brain metastases must have been without symptoms for at least 3 months
- Surgery up to 4 weeks prior to the initial administration of aflibercept and/or incomplete wound healing
- Anti-VEGF therapy up to 4 weeks prior to the initial administration of aflibercept (for phase 1 only)
- Chemotherapy up to 4 weeks prior to the initial administration of aflibercept (for phase 1 only)
- Other investigational treatment up to 4 weeks prior to the initial administration of aflibercept
- Any of the following up to 6 months (24 weeks) prior to the initial administration of aflibercept:
- Severe cardiovascular disease or event
- Cerebrovascular accident, transient ischemic attack, or moderate to severe peripheral neuropathy
- Erosive esophagitis or gastritis, infectious or inflammatory bowel disease, and diverticulitis
- Deep vein thrombosis, pulmonary embolism, or other clotting event
- Episode(s)of moderate to severe, continuous bleeding
- Breast-feeding or pregnancy
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Arizona Cancer Institute, LLCTucson, Arizona
- University of Arkansas for Medical ScienceLittle Rock, Arkansas
- Stanford University Medical CenterStanford, California
- Palm Beach Institute of Hematology and OncologyBoynton Beach, Florida
- Edward Hines Jr. VA Medical CenterHines, Illinois
- Kentucky Cancer ClinicHazard, Kentucky
- Sidney Kimmel Comprehensive Cancer CenterBaltimore, Maryland
- Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire
- UNM Cancer ClinicAlbuquerque, New Mexico
- Roswell Park Cancer InstituteBuffalo, New York
- Montefiore Medical CenterThe Bronx, New York
- Presbyterian Hospital Center for Cancer ResearchCharlotte, North Carolina
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 10, 2020. Always confirm current availability with the study team.