A Study in advanced squamous non small cell lung cancer
- Conditions
- Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)MedDRA version: 14.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-003201-96-ES
- Lead Sponsor
- illy S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 70
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
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
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 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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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:<br>? to evaluate OS, PFS, DCR, and CTS;<br>? to evaluate the safety profile of necitumumab in combination with gemcitabine-cisplatin chemotherapy;<br>? to characterize pharmacokinetics of necitumumab; and<br>? 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 Outcome Measures
Name Time Method Secondary end point(s): - To evaluate OS, PFS, DCR, and CTS;<br>- to evaluate the safety profile of necitumumab in combination with gemcitabine-cisplatin chemotherapy;<br>- to characterize pharmacokinetics of necitumumab; and<br>- to determine the immunogenicity of necitumumab.;Timepoint(s) of evaluation of this end point: Approximately 6 months after completing enrollment of the study population