Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

Percentage of Participants Who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) Objective Tumor Response Rate (ORR)
ORR is confirmed best overall tumor response of CR or PR. According to RECIST v1.1, PR defined as a \>30% decrease in the sum of the longest diameters (LD) of the target lesions, taking as reference the baseline sum of the LD; CR was defined as the disappearance of all target and non-target lesions. Percentage of participants was calculated as: total number of participants with a best tumor response of PR or CR among participants counted in the denominator/total number of participants treated with any amount of study drug, who has a complete radiographic assessment at baseline, and who has at least 1 complete radiographic assessment at postbaseline x 100%.
Baseline to Measured Progressive Disease (up to 17 Months)

Secondary Outcomes (6)

Overall Survival (OS)
Baseline to Death from Any Cause (up to 17 Months)
Progression Free Survival (PFS)
Baseline to Measured Progressive Disease or Death from Any Cause (up to 17 Months)
Number of Participants Who Achieve Best Overall Disease Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) [Disease Control Rate (DCR)]
Baseline to Measured Progressive Disease or Participants Stops Study (up to 17 Months)
Percent Change in Tumor Size (CTS)
Baseline until Measured Progressive Disease (up to 17 Months)
Pharmacokinetics (PK): Minimum (Cmin) Maximum Concentration (Cmax) of Necitumumab
Predose Cycle 1 Day 8; Cycle 2 through 6 Day 1; End of Infusion (EOI) Cycle 1, 3, 5 Day 1
+1 more secondary outcomes

Study Arms (1)

Gemcitabine + Cisplatin + Necitumumab

EXPERIMENTAL

Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle. Gemcitabine administered IV at 1250 milligram per square meter (mg/m\^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles. Cisplatin administered IV at 75 mg/m\^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles.

Drug: NecitumumabDrug: GemcitabineDrug: Cisplatin

Interventions

NecitumumabDRUG

Administered IV

Also known as: IMC-11F8, LY3012211, Portrazza®

Gemcitabine + Cisplatin + Necitumumab

GemcitabineDRUG

Administered IV

Also known as: Gemzar®, LY188011

Gemcitabine + Cisplatin + Necitumumab

CisplatinDRUG

Administered IV

Gemcitabine + Cisplatin + Necitumumab

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Histologically or cytologically confirmed squamous Non-small Cell Lung Cancer (NSCLC)
Stage IV disease at time of study entry based on American Joint Committee on Cancer 7th edition
Measurable disease at time of study entry as defined by Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1
Required to have a performance status (PS) 0-1

You may not qualify if:

Nonsquamous NSCLC
Prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the epidermal growth factor receptor (EGFR), vascular endothelial growth factor (VEGF), or VEGF receptor
Previous chemotherapy for NSCLC
Major surgery or received any investigational therapy in the 4 weeks prior to study enrollment
Chest irradiation within 12 weeks prior to randomization (except palliative irradiation of bone lesions, which is allowed)
Brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants (participants who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic and no longer require treatment with steroids or anticonvulsants, are eligible)

Contact the study team to confirm eligibility.