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
INN or Proposed INN: see 'D.3.9.3 Other descriptive name' below
CAS Number: 906805-06-9
Other descriptive name: NECITUMUMAB
Concentration unit:
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 The patient has an Eastern Cooperative Oncology Group performance status score of 0-1, the patient has an estimated life expectancy of at least 12 weeks and in the judgment of the investigator, will be able to complete at least 2 cycles of treatment. 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 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
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 study enrollment Chest irradiation within 12 weeks prior to study enrollment (except palliative irradiation of bone lesions, which is allowed) The patient has brain metastases that are symptomatic or require ongoing treatment with steroids or anticonvulsants. (Patients who have completed radiotherapy for brain metastases at least 4 weeks prior to receiving treatment, who are now nonsymptomatic and have not required treatment with steroids or anticonvulsants during the 2 weeks prior to receiving treatment, are eligible.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to estimate the best objective response rates (ORR; complete response [CR] + partial response [PR]) associated with gemcitabine-cisplatin plus necitumumab in chemotherapy-naïve patients with Stage IV squamous cell NSCLC.;Secondary Objective: The secondary objectives of this study are: • to evaluate OS, PFS, DCR, and CTS; • to evaluate the safety profile of necitumumab in combination with gemcitabine-cisplatin chemotherapy; • to characterize pharmacokinetics of necitumumab; and • to determine the immunogenicity of necitumumab. ;Primary end point(s): To estimate ORR in the study population;Timepoint(s) of evaluation of this end point: Approximately 6 months after completing enrollment of the study population | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - To evaluate OS, PFS, DCR, and CTS; - to evaluate the safety profile of necitumumab in combination with gemcitabine-cisplatin chemotherapy; - to characterize pharmacokinetics of necitumumab; and - to determine the immunogenicity of necitumumab. ;Timepoint(s) of evaluation of this end point: Approximately 6 months after completing enrollment of the study population | — |
Countries
Canada, France, Korea, Republic of, Netherlands, Spain, Taiwan, United States
Contacts
Public ContactClinical Trial Information
Eli Lilly
Outcome results
None listed