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



Status:Withdrawn
Conditions:Lung Cancer, Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:11/23/2016
Start Date:November 2016
End Date:February 2019

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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)

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.


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.
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Haine-St.- Paul,
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Edina, Minnesota 55435
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Edina, MN
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