A Study in advanced squamous non small cell lung cancer

Conditions: Stage IV Squamous Non-Small Cell Lung Cancer (NSCLC)
MedDRA version: 16.1Level: 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-NL

Lead Sponsor: Eli Lilly and Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 70

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

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.)