First Line Chemotherapy Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: enzastaurin; pemetrexed; docetaxel; carboplatin
Intervention description: 1125-1200 milligrams (mg) loading dose then 500 mg, oral, daily, until disease progression; 500 milligrams per square meter (mg/m^2), intravenous (IV), once every (q) 21 days, six 21 day cycles or progressive disease; 75 mg/m^2, IV, q 21 days, six 21 day cycles or progressive disease; Area under the curve (AUC) 6, IV, q 21 days, six 21 day cycles or progressive disease
Intervention MeSH terms: Carboplatin; Docetaxel; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 218.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purposes of this study are to determine:

      The safety of enzastaurin plus pemetrexed with carboplatin, pemetrexed with carboplatin, or
      docetaxel with carboplatin and any side effects that might be associated with the combination
      of these drugs.

      Whether the combination of enzastaurin plus pemetrexed and carboplatin or pemetrexed and
      carboplatin can help participants with non-small cell lung cancer (NSCLC) live longer,
      compared with the combination of docetaxel and carboplatin.

      Whether the combination of enzastaurin plus pemetrexed and carboplatin or pemetrexed and
      carboplatin can make your tumor smaller or disappear, and for how long, compared with the
      combination of docetaxel and carboplatin.

      The effects of enzastaurin plus pemetrexed with carboplatin, pemetrexed with carboplatin or
      docetaxel with carboplatin have on your disease related symptoms.

      The relation of smoking history and hormone replacement therapy (for women only) may have to
      your lung cancer treatment results.

      The effects of certain genes and proteins in samples of your blood and tumor tissue in order
      to learn more about NSCLC and how enzastaurin works in the body.
    

Eligibility criteria:

        Inclusion Criteria:

          -  You must have been diagnosed with NSCLC.

          -  You must be able to visit the doctor's office weekly during the active treatment
             period and as needed during the study follow-up period.

          -  You must be willing and able to swallow capsules.

          -  Your entry labs and medical tests must meet study requirements.

          -  You must be willing to have blood samples drawn and tissue samples obtained for gene
             and protein testing.

        Exclusion Criteria:

          -  You have received radiation within 2 weeks of study enrollment.

          -  You have previously received any anti-cancer drug therapy for NSCLC.

          -  You have an active infection or other serious condition.

          -  You take aspirin or aspirin-like medication regularly and are not able to stop taking
             them for a few days during each cycle of chemotherapy.

          -  You have recently lost a significant amount of weight.