Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) MedDRA version: 16.1 Level: PT Classification code 10029522 Term: Non-small cell lung cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Necitumumab
Pharmaceutical Form: Infusion
CAS Number: 906805-06-9
Other descriptive name: NECITUMUMAB
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentr
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Histologically or cytologically confirmed squamous NSCLC Stage IV disease at time of study entry based on AJCC 7th edition Measurable disease at time of study entry as defined by RECIST 1.1 Archived or recent tumor tissue (minimum of 5 unstained tissue slides or a paraffin-embedded tissue block) available for analysis of EGFR protein expression by IHC and other biomarker assessments. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 114 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 75
Exclusion criteria
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 (patients who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic and no longer require treatment with steroids or anticonvulsants, are eligible)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to estimate the objective response rates (ORR; complete response [CR] + partial response [PR]) associated with the study treatments of paclitaxel-carboplatin plus necitumumab (Arm A) and paclitaxel-carboplatin (Arm B) in chemotherapy-naïve patients with Stage IV squamous cell NSCLC.;Secondary Objective: • to assess the relationship between EGFR protein expression (as measured by IHC) and each of several efficacy measures: OS, PFS, best tumor response, disease control rate, and change in tumor size; • to evaluate OS, PFS, DCR, and CTS between treatment arms; • to evaluate the safety profile of necitumumab in combination with paclitaxel-carboplatin chemotherapy; • to characterize pharmacokinetics of necitumumab (Arm A only); and • to determine the immunogenicity of necitumumab (Arm A only). Exploratory objectives are to further evaluate the relationships between biomarkers (related to the EGFR-pathway, NSCLC etiology, and the mechanism of action of necitumumab) and efficacy and safety outcomes, as follows: • Tumor Tissue: Biomarkers that may include, but not be limited to, HER2 and HER3 protein expression (measured by IHC), and EGFR gene copy number (measured by FISH); • Whole Blood: FC?R single-nucleotide polymorphisms (by PCR-based method); • Plasma Proteomics. ;Primary end point(s): to estimate ORR for each of the 2 study treatment arms;Timepoint(s) of evaluation of this end point: 98 OS events | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • to assess the relationship between EGFR protein expression (as measured by immunohistochemistry [IHC]) and each of several efficacy measures: overall survival (OS), progression-free survival (PFS), best tumor response, disease control rate (DCR; complete response [CR] + partial response [PR] + stable disease [SD]), and change in tumor size (CTS); • to evaluate OS, PFS, DCR, and CTS between treatment arms; • to evaluate the safety profile of necitumumab in combination with paclitaxelcarboplatin chemotherapy; • to characterize pharmacokinetics of necitumumab (Arm A only); and • to determine the immunogenicity of necitumumab (Arm A only).;Timepoint(s) of evaluation of this end point: 98 OS events | — |
Countries
Germany, Korea, Republic of, Mexico, Russian Federation, United States
Contacts
Public ContactClinical Trial Information
Eli Lilly
Outcome results
None listed