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

Eli Lilly and Company

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Locally Advanced Squamous Non-Small Cell Lung Cancer Metastatic Squamous Non-Small Cell Lung Cancer

Interventions

NecitumumabDRUG

Administered IV

GemcitabineDRUG

Administered IV

CarboplatinDRUG

Administered IV

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (19)

Outcomes

Primary Outcomes

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 Outcomes

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)

Data from ClinicalTrials.gov

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Fairview Southdale Oncology Clinic

Edina, Minnesota, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Haine-St.- Paul, Belgium

Liège, Belgium

Roeselare, Belgium

Bamberg, Germany

Hanover, Germany

Kassel, Germany

Avellino, Italy

Messina, Italy

Naples, Italy

...and 9 more locations