Trial Search Results

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).

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Regeneron Pharmaceuticals

Collaborator: Sanofi


  • Drug: Aflibercept
  • Drug: Pemetrexed
  • Drug: Cisplatin


Phase 1/Phase 2


Inclusion Criteria:

   - Confirmation of cancer by biopsy (tissue sample)

   - Phase 1: patients with advanced or metastatic disease that have failed conventional

   - 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

Exclusion Criteria:

   - 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

   - Any of the following up to 6 months (24 weeks) prior to the initial administration of

      - 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

      - Deep vein thrombosis, pulmonary embolism, or other clotting event

      - Episode(s)of moderate to severe, continuous bleeding

   - Breast-feeding or pregnancy

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study


Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
Not Recruiting