Conditions

Thoracic NeoplasmsLung DiseasesLung CancerRespiratory Tract DiseasesRespiratory Tract NeoplasmsAntineoplastic AgentsMonoclonal Antibodies

Outcome Measures

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

Overall Survival (OS)
Baseline to Date of Death Due to Any Cause (Approximately 24 Months)
Progression Free Survival (PFS)
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
Baseline to Measured Progressive Disease or Start of New Anti-Cancer Therapy (Approximately 24 Months)
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
Cycle 1 Day 1 through Cycle 6 Day 1 (Approximately 4 Months)

EXPERIMENTAL

Predominately European sites. Gemcitabine administered intravenously (IV) and carboplatin IV plus necitumumab IV.

Drug: NecitumumabDrug: GemcitabineDrug: Carboplatin

EXPERIMENTAL

Predominately United States sites. Gemcitabine administered IV and carboplatin IV plus necitumumab IV.

Drug: NecitumumabDrug: GemcitabineDrug: Carboplatin

Administered IV

Also known as: LY3012211

Cohort 1: Necitumumab + Gemcitabine and CarboplatinCohort 2: Necitumumab + Gemcitabine and Carboplatin

Administered IV

Also known as: LY188011

Cohort 1: Necitumumab + Gemcitabine and CarboplatinCohort 2: Necitumumab + Gemcitabine and Carboplatin

Administered IV

Cohort 1: Necitumumab + Gemcitabine and CarboplatinCohort 2: Necitumumab + Gemcitabine and Carboplatin

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

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.

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.

Contact the study team to confirm eligibility.