Clinical Trials /

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

NCT02259582

Description:

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.

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Completed

Phase:

Phase 2

Trial Eligibility

Document

A Study of <span class="go-doc-concept go-doc-intervention">Carboplatin</span>, <span class="go-doc-concept go-doc-intervention">Pemetrexed</span> Plus <span class="go-doc-concept go-doc-intervention">Placebo</span> vs <span class="go-doc-concept go-doc-intervention">Carboplatin</span>, <span class="go-doc-concept go-doc-intervention">Pemetrexed</span> Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With Non-Squamous Non-Small Cell <span class="go-doc-concept go-doc-disease">Lung Cancer</span>

Title

  • Brief Title: 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
  • Official Title: A 3-Arm Phase 2 Double-Blind Randomized Study of Carboplatin, Pemetrexed Plus Placebo Versus Carboplatin, Pemetrexed Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With Non-Squamous Non-Small Cell Lung Cancer
  • Clinical Trial IDs

    NCT ID: NCT02259582

    ORG ID: M18-007

    Trial Conditions

    Nonsquamous Nonsmall Cell Neoplasm of Lung

    Trial Interventions

    Drug Synonyms Arms
    Pemetrexed Arm 1 Pem, carbo, placebo x 4 cycles, Arm 2 Pem, carbo x 4 cycles, one course of dem, Arm 3 pem, carbo, dem x 4 cycles, dem retreatment
    Carboplatin Arm 1 Pem, carbo, placebo x 4 cycles, Arm 2 Pem, carbo x 4 cycles, one course of dem, Arm 3 pem, carbo, dem x 4 cycles, dem retreatment
    demcizumab Arm 2 Pem, carbo x 4 cycles, one course of dem, Arm 3 pem, carbo, dem x 4 cycles, dem retreatment

    Trial Purpose

    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.

    Detailed Description

    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.

    Trial Arms

    Name Type Description Interventions
    Arm 1 Pem, carbo, placebo x 4 cycles Placebo Comparator Pemetrexed (500 mg/m2),carboplatin (area under the concentration-time curve of 6 mg/mL x min) once every 21 days X 4 cycles, pemetrexed maintenance and placebo starting at Day 84 Pemetrexed, Carboplatin
    Arm 2 Pem, carbo x 4 cycles, one course of dem Active Comparator Pemetrexed (500 mg/m2), carboplatin (area under the concentration-time curve of 6 mg/mL x min) x 4 cycles, one course of demcizumab 5mg/kg, maintenance pemetrexed + placebo starting on Day 84 Pemetrexed, Carboplatin, demcizumab
    Arm 3 pem, carbo, dem x 4 cycles, dem retreatment Active Comparator Pemetrexed (500 mg/m2), carboplatin (area under the concentration-time curve of 6 mg/mL x min) x 4 cycles, maintenance pemetrexed starting on Day 84. 2 courses of demcizumab 5 mg/kg Pemetrexed, Carboplatin, demcizumab

    Eligibility Criteria

    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

    Minimum Eligible Age: 21 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Investigator-assessed median progression-free survival (PFS)

    Secondary Outcome Measures

    Investigator-assessed RECIST v1.1 response rate

    Trial Keywords

    Phase 2

    histologically

    confirmed

    malignancy

    metastatic

    pemetrexed

    carboplatin

    carcinoma

    non small cell lung

    lung neoplasms

    lung diseases