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Non-Small Cell Lung Cancer Treated with nab-Paclitaxel (Abraxane) and Carboplatin Chemotherapy plus Necitumumab

Clinical Trial Title: 
A single-arm, multicenter, open-label, phase 2 study of nab-paclitaxel (abraxane) and carboplatin chemotherapy plus necitumumab in the first-line treatment of patients with stage IV squamous non-small cell lung cancer (NSCLC).
Clinical Trial Protocol ID: 
14070201
Clinical Trial Investigator Name: 
Marta Batus, MD
Clinical Trial Protocol Description: 

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).

Clinical Trial Eligibility Criteria: 

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.

Clinical Trial Area: 
Lung and Chest Tumors
Contact Phone: 
(312) 563-3921
Contact Name: 
Emily Rubenstein RN