Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatments necitumumab, gemcitabine, cisplatin
Phase phase 2
Target EGFR
Sponsor Eli Lilly and Company
Start date March 2013
End date August 2014
Trial size 60 participants
Trial identifier NCT01788566, 14789, I4X-MC-JFCK

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(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.
necitumumab IMC-11F8
Administered IV
gemcitabine Gemzar
Administered IV
cisplatin
Administered IV

Primary Outcomes

Measure
Number of Participants who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) [Objective Tumor Response Rate (ORR)]
time frame: Baseline to Measured Progressive Disease (Estimated up to 24 Months)

Secondary Outcomes

Measure
Overall Survival (OS)
time frame: Baseline to Death from Any Cause (Estimated up to 27 Months)
Progression Free Survival (PFS)
time frame: Baseline to Measured Progressive Disease or Death from Any Cause (Estimated up to 24 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)]
time frame: Baseline to Measured Progressive Disease or Participants Stops Study (Estimated up to 24 Months)
Percent Change in Tumor Size (CTS)
time frame: Baseline until Measured Progressive Disease (Estimated up to 24 Months)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Necitumumab
time frame: Predose up to 24 Hours Post Dose
Number of Participants with Anti-Necitumumab Antibodies
time frame: Baseline up to 30 Days Post Last Infusion (Estimated up to 24 Months)

Eligibility Criteria

Male or female participants at least 18 years old.

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 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)

Additional Information

Official title A Single-Arm, Multicenter, Open-Label, Phase 2 Study of Gemcitabine-Cisplatin Chemotherapy Plus Necitumumab (IMC-11F8) in the First-Line Treatment of Patients With Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.