A Study of Carboplatin, Pemetrexed Plus Placebo vs Carboplatin, Pemetrexed Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With Non-Squamous Non-Small Cell Lung Cancer
Condition: Nonsquamous Nonsmall Cell Neoplasm of Lung
MeSH terms: Lung Neoplasms
Intervention: Pemetrexed; Carboplatin; demcizumab
Intervention MeSH terms: Carboplatin; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 82.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Phase 2; histologically; confirmed; malignancy; metastatic; pemetrexed; carboplatin; carcinoma; non small cell lung; lung neoplasms; lung diseases

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.
    

Eligibility criteria:

        Main Inclusion Criteria:

          1. Signed Informed Consent Form

          2. Histologically or cytologically confirmed Stage IV non-squamous NSCLC

          3. Availability of FFPE (formalin-fixed paraffin-embedded) tumor tissue, either fresh
             core-needle-biopsied or archived

          4. Age > or = to 21 years

          5. ECOG (Eastern Cooperative Oncology Group) 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 (epidermal growth factor receptor ) mutation or anaplastic
             lymphoma kinase (ALK) gene translocation (such as EML4 [echinoderm
             microtubule-associated protein-like 4]-ALK [anaplastic lymphoma kinase])

          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) or tracheo-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