Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC) MedDRA version: 19.0 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
Sponsors
Lilly, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Key Inclusion Criteria - Histologically or cytologically confirmed squamous NSCLC - Stage IV disease at the time of study entry (AJCC Staging Manual, 7th edition) - Measurable disease at the time of study enrollment, as defined by RECIST 1.1 - Tumor tissue (paraffin-embedded tissue block [preferred] or 15 freshly cut unstained slides [a minimum of 6 slides] is requested) available for analysis of EGFR protein expression by immunohistochemistry (IHC). 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 31 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 19
Exclusion criteria
Exclusion criteria: Key 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 advanced NSCLC - Major surgery or received any investigational therapy in the 4 weeks prior to study entry - Systemic radiotherapy within 4 weeks prior to study entry, or focal radiotherapy within 2 weeks prior to study entry - Symptomatic central nervous system (CNS) malignancy or metastasis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the best objective response rate (ORR; complete response [CR] + partial response [PR]) associated with a treatment regimen of nab-paclitaxel and carboplatin chemotherapy plus necitumumab as first-line therapy in patients with Stage IV squamous NSCLC.; Secondary Objective: The secondary objectives of the study are to: - evaluate progression-free survival (PFS), - evaluate overall survival (OS), - evaluate disease control rate (DCR), - evaluate the safety profile of necitumumab in combination with carboplatin and/or nab-paclitaxel chemotherapy, - determine the pharmacokinetics (PK) of necitumumab, nab-paclitaxel, and carboplatin, and - determine the immunogenicity of necitumumab (anti-necitumumab antibodies) ;Primary end point(s): ORR (CR and PR) in qualified patients based on tumor assessment using RECIST 1.1;Timepoint(s) of evaluation of this end point: The final analysis for all outcomes, primary and secondary endpoints, will be performed when 70% of qualified patients experience a PFS event(radiographically documented PD or death), or 6 months after completing enrollment, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary objectives of the study are to: - evaluate progression-free survival (PFS), - evaluate overall survival (OS), - evaluate disease control rate (DCR), - evaluate the safety profile of necitumumab in combination with carboplatin and/or nab-paclitaxel chemotherapy, - determine the pharmacokinetics (PK) of necitumumab, nab-paclitaxel, and carboplatin, and - determine the immunogenicity of necitumumab (anti-necitumumab antibodies) ;Timepoint(s) of evaluation of this end point: The final analysis for all outcomes, primary and secondary endpoints, will be performed when 70% of qualified patients experience a PFS event(radiographically documented PD or death), or 6 months after completing enrollment, whichever occurs first. | — |
Countries
Germany, Greece, Spain, United States
Contacts
Public ContactEnsayos Clínicos
Lilly
Outcome results
None listed