A Study of Induction and Maintenance Treatment of Advanced or Metastatic Non Squamous Non-Small Cell Lung Cancer
Condition: Non-Small-Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Pemetrexed; Cisplatin; Cetuximab
Intervention description: Induction therapy: 500 mg/m², intravenous, on Day 1 of each 21-day cycle for 4 to 6 cycles Maintenance therapy: 500 mg/m², intravenous, on Day 1 of each 21-day cycle until progressive disease or treatment discontinuation; Induction therapy: 75 mg/m², intravenous, on Day 1 of each 21-day cycle for 4 to 6 cycles; Induction therapy: Loading dose of 400 mg/m², intravenous, on Day 1 of cycle 1, then 250 mg/m², intravenous, weekly for 4 to 6 cycles, 21 day cycles
Maintenance therapy: 250 mg/m², intravenous, weekly until progressive disease or treatment discontinuation
Intervention MeSH terms: Pemetrexed; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 113.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will estimate the response rate in patients with advanced or metastatic
      non-squamous Non-Small Cell Lung Cancer. Patients who don't progress after 4 to 6 cycles of
      induction treatment with pemetrexed, cisplatin and cetuximab will receive maintenance
      treatment with pemetrexed and cetuximab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must sign an informed consent document for clinical and translational
             research.

          -  Patient must have locally advanced or metastatic nonsquamous Non-Small Cell Lung
             Cancer.

          -  Patient must have biological tissue available from your diagnosis tumor for detection
             of some biomarkers (translational research).

          -  Patient cannot be receiving nor have received any prior systemic anticancer therapy,
             immunotherapy, targeted therapy, or biological therapy for your lung cancer (except
             chemotherapy given after surgery if it has been completed more than one year before
             the study entry).

          -  Patient is allowed to have had prior radiation therapy as long as it was not more than
             25% of the bone marrow and did not include the whole pelvis. Prior radiation therapy
             should be completed at least 2 weeks prior to first study drug. Thoracic radiation
             must be completed more than 12 weeks before the study entry. You must be recovered
             from the toxic effects.

          -  Patient must have at least 1 measurable tumor lesion according to the Response
             Evaluation Criteria in Solid Tumors (RECIST) guidelines.

          -  Patient must at least be able to be physically mobile, take care of yourself, and must
             be up and about and able to perform light activities such as light housework or office
             work.

          -  Test results assessing the function of blood forming tissue, kidneys, and liver must
             be satisfactory.

          -  Females must be sterile, postmenopausal or on contraception.

          -  Males must be on contraception or sterile (for example post-vasectomy).

        Exclusion Criteria:

          -  Patient cannot have symptomatic central nervous system metastases.

          -  Patient cannot have an active infection or other serious condition that your doctor
             thinks would make you unable to participate.

          -  Patient cannot have a serious cardiac condition, such as a heart attack, angina, or
             heart disease within 6 months of entering the trial.

          -  Patient cannot have had a another form of cancer other than superficial basal cell and
             superficial squamous (skin) cell cancer, or carcinoma in situ of the cervix within the
             last 5 years.

          -  Patient cannot have had significant neurologic or psychiatric disorders including
             dementia, seizures and bipolar disorder.

          -  Patient cannot have moderate or severe peripheral neuropathy

          -  Patient cannot have received treatment within 30 days with any experimental drug.

          -  Patient cannot have had a major surgery within the last 4 weeks.

          -  Patient cannot have previously received treatment with transduction inhibitors or
             Epidermal Growth Factor Receptor (EGFR)-targeting therapy.

          -  Patient cannot have prior known allergic/hypersensitivity reaction to any of the
             components of study treatments.

          -  Females cannot be pregnant or breastfeeding.

          -  Patient is unable to stop taking more than 1.3 grams of aspirin on a daily basis or
             other aspirin like medication (non-steroidal antiinflammatory drugs: NSAIDs) for a few
             days during each cycle of therapy.

          -  Patient is unable or unwilling to take folic acid, injections of vitamin B12, or
             corticosteroids.

          -  Patient cannot have fluid around your lungs or in your abdomen (pleural effusions or
             ascites) that cannot be controlled by drainage or other procedures.

          -  Patient cannot have received a yellow fever vaccination within the previous 30 days or
             plan to have it.

          -  Patient cannot have known drug abuse.