Non-Small Cell Lung Cancer Treated with nab-Paclitaxel (Abraxane) and Carboplatin Chemotherapy plus Necitumumab
The purpose of this study is to find out how well nab-paclitaxel (abraxane) and carboplatin chemotherapy plus necitumumab works in the first-line treatment of patients with stage IV squamous non-small cell lung cancer (NSCLC).
In order to participate you must meet the following criteria:
- Have histologically or cytologically confirmed stage IV squamous NSCLC.
- Have measureable disease at time of enrollment.
- Have archival tumor tissue – paraffin-embedded tissue block or fresh cut slides for analysis of EGFR expression is mandatory.
- Have ECOG performance status of 0 or 1.
You will be excluded from the study if any of the following criteria apply to you:
- Have histologically or cytologically documented non-squamous NSCLC (including adenocarcinoma, large cell, and not otherwise specified).
- Have prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the EGFR, VEGF, or VEGF receptor.
Have previous chemotherapy for advanced NSCLC.
- Patients who have had adjuvant or neoadjuvant chemotherapy are eligible if the last administration of prior regimens occurred at least 1 year prior to study entry.
- Have had major surgery or investigational therapy in the 4 weeks prior to study entry.
- Have had systemic radiotherapy within 4 weeks prior to study entry or focal radiotherapy within 2 weeks prior to study entry.
- Have symptomatic CNS malignancy or metastasis.
- Are currently enrolled in another clinical trial judged not to be scientifically or medically compatible with this study.
- Have a history of arterial or venous embolism within 6 months prior to study entry.
- Have current clinically relevant coronary artery disease or congestive heart failure.
- Have a history of myocardial infarction within 6 months prior to study entry.
- Have clinical evidence of concomitant infectious conditions, including active infection, tuberculosis, or HIV.
- Have greater than or equal to Grade 2 peripheral neuropathy.
- Have concurrent active malignancy.
- Have had concurrent treatment with other anticancer therapy including other chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemo-embolization, targeted therapy, or an investigational agent.
This is a partial list of inclusion and exclusion criteria.