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Summary

for people ages 21 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

A randomized, double-blind, 3-arm (1:1:1) study in subjects with first-line Stage IV non-squamous NSCLC. The purpose is to test the efficacy and safety of demcizumab, when given in combination with carboplatin and pemetrexed compared to placebo. The administration of carboplatin and pemetrexed is a standard treatment for patients with non-squamous non-small cell lung cancer.

Official Title

A 2-Arm Phase 2 Double-Blind Randomized Study of Carboplatin, Pemetrexed Plus Placebo Versus Carboplatin, Pemetrexed Plus Truncated Demcizumab as First-Line Treatment in Subjects With Stage IV Non-Squamous Non-Small Cell Lung Cancer

Details

Patients will be enrolled at centers in North America, Western Europe, Australia and New Zealand. Up to 28 days (4 weeks) prior to treatment.

If enrolled in the study, you will receive intravenous (in the vein) infusions of demcizumab (or placebo), carboplatin, and pemetrexed administered on the same day, every 21 days for 4 cycles, or until it has been shown that your cancer has gotten worse. If your physician decides to delay treatment with one of the agents due to side effects, the other agents may still be administered as scheduled. After 4 cycles, if you have stable or improved disease, you will continue to receive pemetrexed once every 21 days as maintenance therapy. After 8 cycles, if you have stable or improved disease, you may receive demcizumab (or placebo), every 21 days for 4 more cycles.

You will undergo assessments every 6 weeks to determine the status of your disease.

Keywords

Nonsquamous Nonsmall Cell Neoplasm of Lung Phase 2 histologically confirmed malignancy metastatic pemetrexed carboplatin carcinoma non small cell lung lung neoplasms lung diseases

Eligibility

For people ages 21 years and up

Main Inclusion Criteria:

  1. Signed Informed Consent Form
  2. Histologically or cytologically confirmed Stage IV non-squamous NSCLC
  3. Availability of FFPE tumor tissue, either fresh core-needle-biopsied or archived
  4. Age> or = to 21 years
  5. ECOG performance status of 0 or 1
  6. Disease that is measurable per RECIST v1.1
  7. Adequate organ and marrow function
  8. For women of childbearing potential, agreement to use two effective forms of contraception

Main Exclusion Criteria:

  1. Histologically or cytologically documented, advanced, mixed non-small cell and small cell tumors or mixed adenosquamous carcinomas
  2. NSCLC with known EGFR mutation or anaplastic lymphoma kinase (ALK) gene translocation(such as EML4-ALK)
  3. Prior or ongoing therapy (including chemotherapy, antibody therapy, tyrosine kinase inhibitors, radiotherapy, immunotherapy, hormonal therapy, or investigational therapy)for the treatment of Stage IV non-squamous NSCLC
  4. Evidence of tumor invading major blood vessels, cavitation of one or more pulmonary tumor mass(es) ortracheo-esophageal fistula
  5. Brain metastases, leptomeningeal disease, uncontrolled seizure disorder, or active neurologic disease
  6. Malignancies other than non-squamous NSCLC successfully treated within 3 years prior to randomization (with the exception of certain early-stage cancers)
  7. History of a significant allergic reaction attributed to humanized or human monoclonal antibody therapy
  8. Significant intercurrent illness defined as an illness that may result in the subject's death prior to their death from non-squamous NSCLC and/or significantly limit their ability to comply with the requirements of this study
  9. Recent hemoptysis>2.5 mL or serious bleeding from another site, known bleeding disorder or coagulopathy or therapeutic anti-coagulation
  10. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to randomization, or anticipation of need for major surgical procedure during the course of the study

Locations

  • Desert Hematology Oncology Medical Group, Inc.
    Rancho Mirage, California, 92270, United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
OncoMed Pharmaceuticals, Inc.
ID
NCT02259582
Phase
Phase 2
Lead Scientist
Matthew Gubens
Study Type
Interventional
Last Updated
August 1, 2017