A Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab in the First-Line Treatment of Participants With Squamous Lung Cancer

Lilly

Status and phase: Completed; Phase 2

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Necitumumab; Drug: Cisplatin; Drug: Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01788566

I4X-MC-JFCK (Other Identifier)

14789

Details and patient eligibility

About

The purpose of this study is to see how participants with late stage lung cancer do on gemcitabine-cisplatin chemotherapy plus necitumumab. The study will also see how safe the drugs are in combination and to see how long the medicine stays in the body. The study will last approximately 2 years.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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61 participants in 1 patient group

Gemcitabine + Cisplatin + Necitumumab

Experimental group

Description:

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.

Treatment:

Drug: Gemcitabine

Drug: Cisplatin

Drug: Necitumumab