Overview

This trial is active, not recruiting.

Condition squamous non small cell lung cancer
Treatments necitumumab, paclitaxel, carboplatin
Phase phase 2
Target EGFR
Sponsor Eli Lilly and Company
Start date January 2013
End date April 2015
Trial size 162 participants
Trial identifier NCT01769391, 14790, 2012-003214-13, I4X-MC-JFCL

Summary

The main purpose of this study is to evaluate if necitumumab added to standard chemotherapy of paclitaxel and carboplatin is more effective to treat cancer than the standard chemotherapy of paclitaxel and carboplatin alone.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle. Paclitaxel 200 milligram per square meter (mg/m^2) administered IV on Day 1 of every 3 week cycle. Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles. Necitumumab may continue until Progressive Disease (PD), toxicity requiring cessation, protocol noncompliance, or withdrawal of consent.
necitumumab LY3012211
Administered IV
paclitaxel
Administered IV
carboplatin
Administered IV
(Active Comparator)
Paclitaxel 200 mg/m^2 administered IV on Day 1 of every 3 week cycle. Carboplatin AUC=6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles. After completion of chemotherapy, participants will be followed until radiographic documentation of PD.
paclitaxel
Administered IV
carboplatin
Administered IV

Primary Outcomes

Measure
Percentage of Participants who Achieve Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) (Objective Response Rates [ORR])
time frame: Baseline to Disease Progression or Death (Estimated up to 24 Months)

Secondary Outcomes

Measure
Overall Survival
time frame: Baseline to Date of Death (Estimated up to 27 Months)
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Necitumumab
time frame: Predose to End of Cycle 6 (Estimated up to 5 Months)
Percentage of Participants with Anti Necitumumab Antibodies
time frame: Baseline to End of Cycle 6 (Estimated up to 5 Months)
Progression-Free Survival
time frame: Baseline to Progressive Disease or Death (Estimated up to 24 Months)
Percentage 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 Progressive Disease and/or Death (Estimated up to 24 Months)
Percent Change in Tumor Size (CTS)
time frame: Baseline to Progressive Disease or Death (Estimated up to 24Months)
Pharmacokinetics (PK): Minimum Concentration (Cmin) of Necitumumab
time frame: Predose to End of Cycle 6 (Estimated up to 5 Months)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically or cytologically confirmed squamous NSCLC - Stage IV disease at time of study entry based on American Joint Committee on Cancer (AJCC) 7th edition - Measurable disease at time of study entry as defined by Response Evaluation Criteria in Solid Tumors, (RECIST) Version 1.1 - Archived or recent tumor tissue (minimum of 5 unstained tissue slides or a paraffin-embedded tissue block) available for analysis of epidermal growth factor receptor (EGFR) protein expression by immunohistochemistry (IHC) and other biomarker assessments Exclusion Criteria: - Nonsquamous NSCLC - Prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the 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 randomization - 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 Randomized, Multicenter, Open-Label, Phase 2 Study of Paclitaxel-Carboplatin Chemotherapy Plus Necitumumab (IMC-11F8) Versus Paclitaxel-Carboplatin Chemotherapy Alone 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 April 2015.
Information provided to ClinicalTrials.gov by Eli Lilly and Company.