A Study of Gemcitabine-Cisplatin Chemotherapy plus Necitumumab in the First-Line Treatment of Patients with Lung Cancer

Overview

About this study

The purpose of this study is to assess the safety and effectiveness of combined gemcitabine and cisplatin chemotherapy plus necitumumab for the treatment of patients who have late stage lung cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

This study is ongoing, but not recruiting participants

Inclusion Criteria

  • Histologically or cytologically confirmed squamous Non-small Cell Lung Cancer (NSCLC)
  • Stage IV disease at time of study entry based on American Joint Committee on Cancer 7th edition
  • Measurable disease at time of study entry as defined by Response Evaluation Criteria in Solid Tumors (RECIST)Version 1.1

Exclusion Criteria

  • Non-squamous NSCLC
  • Prior anticancer therapy with monoclonal antibodies, signal transduction inhibitors, or any therapies targeting the epidermal growth factor receptor (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 (participants who have undergone previous radiotherapy for brain metastases, who are now nonsymptomatic and no longer require treatment with steroids or anticonvulsants, are eligible)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Helen Ross, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available
.

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