A Study of Gemcitabine-Carboplatin Plus Necitumumab (LY3012211) in Chemotherapy-Naïve Participants With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)

Overview

The main purpose of this study is to evaluate the effectiveness and safety of gemcitabine-carboplatin plus necitumumab in chemotherapy-naïve participants with locally advanced or metastatic squamous non-small cell lung cancer.

Full Title of Study: “A Multicenter, Phase 2 Study of Gemcitabine-Carboplatin Plus Necitumumab in Chemotherapy-Naïve Patients With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2017

Interventions

  • Drug: Necitumumab
    • Administered IV
  • Drug: Gemcitabine
    • Administered IV
  • Drug: Carboplatin
    • Administered IV

Arms, Groups and Cohorts

  • Experimental: Cohort 1: Necitumumab + Gemcitabine and Carboplatin
    • Predominately European sites. Gemcitabine administered intravenously (IV) and carboplatin IV plus necitumumab IV.
  • Experimental: Cohort 2: Necitumumab + Gemcitabine and Carboplatin
    • Predominately United States sites. Gemcitabine administered IV and carboplatin IV plus necitumumab IV.

Clinical Trial Outcome Measures

Primary Measures

  • Objective Response Rate (ORR): Percentage of Participants With a Complete or Partial Response
    • Time Frame: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 18 Months)

Secondary Measures

  • Overall Survival (OS)
    • Time Frame: Baseline to Date of Death Due to Any Cause (Approximately 24 Months)
  • Progression Free Survival (PFS)
    • Time Frame: Baseline to Measured Progressive Disease or Death (Approximately 24 Months)
  • Disease Control Rate (DCR): Percentage of Participants With a Best Overall Response of Complete Response, Partial Response, and Stable Disease
    • Time Frame: Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 24 Months)
  • Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
    • Time Frame: Cycle 1 Day 1 through Cycle 6 Day 1 (Approximately 4 Months)

Participating in This Clinical Trial

Inclusion Criteria

  • Have confirmed diagnosis of locally advanced or metastatic NSCLC in Cohort 1 and metastatic NSCLC in Cohort 2, predominantly squamous histology. Squamous NSCLC diagnosis must be confirmed by histology or cytology local pathology report. – Participants in Cohort 1 are required to have epidermal growth factor receptor (EGFR) protein expressing tumor (defined by local immunohistochemistry test). This is not required for participants in Cohort 2. – Measurable disease at the time of study entry as defined by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) – The participant has an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-1 – Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy: Biologic agents (for example, antibodies) and Immunotherapy ≥4 weeks; Chest radiotherapy ≥4 weeks; Major surgery, excluding biopsy ≥4 weeks) – The participant has archived tumor tissue available for biomarker analyses. – Participants in Cohort 2 are required to have received 1 prior single-agent immune checkpoint inhibitor for squamous NSCLC. Exclusion Criteria:

  • The participant has nonsquamous NSCLC – The participant has received prior anticancer therapy targeting the EGFR, vascular endothelial growth factor (VEGF), or VEGF receptor. – The participant has received previous chemotherapy (including concurrent chemoradiation) for advanced NSCLC (participants who have received neo-adjuvant and/or adjuvant chemotherapy are eligible if the last administration occurred at least 1 year prior to start of therapy). – The participant has brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants. – The participant has a bleeding tumor. – The participant has a history of arterial or venous thromboembolism within 3 months prior to study enrollment. – The participant has a history or evidence of current clinically-relevant coronary artery disease of current ≥ Class III as defined by Canadian Cardiovascular Society Angina Grading Scale (Campeau 1976) or congestive heart failure of current ≥ Class III as defined by the New York Heart Association. – The participant has experienced myocardial infarction within 6 months prior to study enrollment.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Eli Lilly and Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon – Fri 9 AM – 5 PM Eastern time (UTC/GMT – 5 hours, EST), Study Director, Eli Lilly and Company

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