Clinical Trials /

A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Participants With EGFR Mutation-Positive Metastatic NSCLC

NCT02411448

Description:

The main purpose of this study is to evaluate the safety and efficacy of ramucirumab in combination with erlotinib as compared to placebo in combination with erlotinib in participants with stage IV non small cell lung cancer (NSCLC) harboring an activating epidermal growth factor receptor (EGFR) mutation (Del19 and L858R). Safety and tolerability of ramucirumab in combination with erlotinib will be assessed in the first portion (Part A) before proceeding to the second portion of this study (Part B). The purpose of Part C is to determine the efficacy and safety of ramucirumab in combination with gefitinib in previously untreated East Asian participants with EGFR mutation-positive metastatic NSCLC and of ramucirumab in combination with osimertinib in those participants whose disease progressed on ramucirumab and gefitinib and that have T790M - positive metastatic NSCLC.

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

Active, not recruiting

Phase:

Phase 3

Trial Eligibility

Document

A Study of <span class="go-doc-concept go-doc-intervention">Ramucirumab</span> (LY3009806) in Combination With <span class="go-doc-concept go-doc-intervention">Erlotinib</span> in Participants With <span class="go-doc-concept go-doc-biomarker">EGFR</span> <span class="go-doc-concept go-doc-keyword">Mutation</span>-Positive Metastatic NSCLC

Title

  • Brief Title: A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Participants With EGFR Mutation-Positive Metastatic NSCLC
  • Official Title: A Multicenter, Randomized, Double-Blind Study of Erlotinib in Combination With Ramucirumab or Placebo in Previously Untreated Patients With EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer
  • Clinical Trial IDs

    NCT ID: NCT02411448

    ORG ID: 15540

    NCI ID: I4T-MC-JVCY

    Trial Conditions

    Metastatic Non-Small Cell Lung Cancer

    Trial Interventions

    Drug Synonyms Arms
    Ramucirumab LY3009806 Ramucirumab + Erlotinib
    Placebo Placebo + Erlotinib
    Erlotinib Ramucirumab + Erlotinib, Placebo + Erlotinib

    Trial Purpose

    The main purpose of this study is to evaluate the safety and efficacy of ramucirumab in
    combination with erlotinib as compared to placebo in combination with erlotinib in
    participants with stage IV non small cell lung cancer (NSCLC) harboring an activating
    epidermal growth factor receptor (EGFR) mutation (Del19 and L858R). Safety and tolerability
    of ramucirumab in combination with erlotinib will be assessed in the first portion (Part A)
    before proceeding to the second portion of this study (Part B).

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Ramucirumab + Erlotinib Experimental (Part A) 10 milligrams per kilogram (mg/kg) ramucirumab every 2 weeks intravenously (IV) in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met. (Part B) 10 mg/kg ramucirumab every 2 weeks IV in combination with 150 mg erlotinib daily orally . Participants may continue to receive treatment until discontinuation criteria are met. Ramucirumab, Erlotinib
    Placebo + Erlotinib Placebo Comparator (Part A) Not Applicable (Part B) Placebo every 2 weeks IV in combination with 150 mg erlotinib daily orally. Participants may continue to receive treatment until discontinuation criteria are met. Placebo, Erlotinib

    Eligibility Criteria

    Inclusion Criteria:

    - Cytologically or histologically confirmed diagnosis of Stage IV NSCLC as defined by
    the American Joint Committee on Cancer Staging Criteria for Lung Cancer (AJCC 7th
    edition 2009).

    - Eligible for first-line treatment with erlotinib based on documented evidence of
    tumor harboring an activating EGFR mutation (Example 19 del and L858R).

    - Mandatory provision of adequate archived stage IV NSCLC tissue sample.

    - At least one measurable lesion.

    - Life expectancy of at least 3 months.

    Exclusion Criteria:

    - Known T790M EGFR mutation.

    - Known leptomeningeal carcinomatosis, uncontrolled/unstable spinal cord compression,
    or brain metastases.

    - Serious illness or medical condition.

    - Ongoing treatment with CYP3A4 inducers or strong/moderate inhibitors.

    - Ongoing therapy with nonsteroidal anti-inflammatory drugs for more than 2 months.

    - History of gross hemoptysis.

    - Significant bleeding disorders.

    - Radiologically documented evidence of major blood vessel invasion or encasement by
    cancer.

    - Radiographic evidence of intratumor cavitation.

    - History of gastrointestinal perforation within last 6 months.

    - History of bowel obstruction, inflammatory enteropathy or extensive intestinal
    resection.

    - History of any arterial thrombotic event within 6 months prior to enrollment.

    - The participant has any known significant ophthalmologic abnormalities of the surface
    of the eye.

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Both

    Primary Outcome Measures

    Progression Free Survival (PFS)

    Number of Participants with One or More Drug Related Adverse Events (AEs) or Any Serious AEs

    Secondary Outcome Measures

    Overall Survival (OS)

    Objective Response Rate (ORR)

    Disease Control Rate (DCR)

    Duration of Response (DoR)

    Pharmacokinetics (PK): Minimum Concentration (CMIN) of Ramucirumab

    Number of Participants with Anti-Ramucirumab Antibodies

    Change from Baseline on the Lung Cancer Symptom Scale (LCSS)

    Change from Baseline on the EuroQol 5-Dimension, 5-Level Questionnaire (EQ-5D-5L)

    Trial Keywords