Patient case: 52-year-old male with Lung cancer. Genetic variant: EML4-ALK Fusion transcript. Other conditions: Hypertension, Osteoarthritis.

Clinical trial: Study of Anti-Epidermal Growth Factor Receptor (EGFr) Antibody, Cetuximab, in Combination With Gemcitabine/Carboplatin in Patients With Stage IV Lung Cancer

Summary: The objective is to evaluate the toxicity profile, response rate, and time to progression of Cetuximab administered in combination with either Carboplatin + Gemcitabine in patients with advanced non-small cell lung cancer with positive EGFr expression.

Detailed description: The primary objective of this study is to evaluate the safety profile of Cetuximab when used in combination with gemcitabine and carboplatin in patients with EGFr positive, chemotherapy-naive, stage IV non-small cell lung cancer (NSCLC).
  Also, the study will determine the response rate in patients with EGFr positive chemotherapy-naive, stage IV non-small cell lung cancer (NSCLC) treated with Cetuximab in combination with gemcitabine and carboplatin as well as determine the time to progression in patients with EGFr positive chemotherapy-naive, stage IV NSCLC treated with Cetuximab in combination with gemcitabine and carboplatin.

Eligibility: Inclusion Criteria:
  -  Have a diagnosis of histologically/cytologically confirmed advanced non- small cell lung cancer (NSCLC).
  -  Have uni-dimensionally measurable and/or evaluable advanced NSCLC.
  -  Have Stage IV or recurrent disease following radiation therapy.
  -  Have ECOG performance status of 0-1 or Karnofsky performance status of 80- 100 at study entry.
  -  Have given signed informed consent.
  -  Be at least 18 years of age.
  -  Have ANC greater than or equal to 1,500/mm3, platelets greater than or equal to 100,000/mm3, WBC greater than or equal to 3,000 mm3, and hemoglobin greater than or equal to 9 g/dL.
  -  Have total bilirubin less than or equal to 1.5 x upper limits of normal, Alk Phos, AST and ALT less than or equal to 2.5 x upper limits of normal.
  -  Have serum creatinine less than or equal to 1.5 mg/dL, or calculated creatinine clearance greater than or equal to 60 cc/minute.
  -  Be disease free from a previously treated malignancy for more than three years. Patients with a history or a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix will not be excluded.
  -  Agree to use effective contraception if procreative potential exists.
  -  Must have positive EGFr expression (tumor tissue) by immunohistochemical assay.
  Exclusion Criteria:
  -  Have received prior murine monoclonal antibody or Cetuximab therapy.
  -  Have disease amenable to curative surgery.
  -  Have received prior chemotherapy.
  -  Have received radiation therapy within 3 weeks prior to the first infusion of Cetuximab.
  -  Have a history of clinically significant cardiac disease, serious arrhythmias, or significant conduction abnormalities, in the judgment of the PI.
  -  Have uncontrolled seizure disorder, active neurological disease, or Grade 2 or higher neuropathy.
  -  Be pregnant or breast-feeding.
  -  Have received any investigational agent(s) within 1 month of study entry.

Relevance to patient case: not relevant