A Study Comparing of Two Different Chemotherapy Regimens, in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: pemetrexed; Best Supportive Care
Intervention description: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles; Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multicenter, open-label, randomized, two-arm Phase 2 study comparing pemetrexed
      plus best supportive care with best supportive care alone as maintenance therapy following
      first-line treatment with a pemetrexed-cisplatin combination in patients with advanced
      non-squamous non-small cell lung cancer.

      A total of approximately 100 patients are planned to be enrolled, and following completion of
      four cycles of pemetrexed-cisplatin (Induction Phase) those patients in which disease
      progression has not occurred will be randomized in a 2:1 ratio to one of two treatment arms
      (Maintenance Phase): Arm A (pemetrexed plus best supportive care) or Arm B (best supportive
      care alone).
    

Eligibility criteria:

        Inclusion criteria:

          1. You must be at least 18 years old

          2. You must have been diagnosed with non-squamous non-small cell lung cancer (NSCLC)

          3. You must have had no prior systemic anticancer therapy for lung cancer

          4. You must live close enough to the study doctor to be able to visit regularly for
             follow up

          5. You must have signed informed consent form indicating your willingness to take part in
             this study

          6. Your laboratory and medical history and tests must meet study requirements

        Exclusion criteria:

          1. Treatment within the last 30 days with a drug that has not received regulatory
             approval for any indication at the time of study entry

          2. Prior radiotherapy and surgery should be completed at least 4 weeks prior to
             initiation of treatment

          3. Serious concomitant systemic disorder (e.g., active infection including human
             immunodeficiency virus, or unstable cardiovascular disease)

          4. Prior malignancy other than NSCLC, carcinoma in situ of the cervix, or nonmelanoma
             skin cancer unless treated at least 5 years previously with no subsequent evidence of
             recurrence

          5. Brain metastasis

          6. Presence of clinically significant (by physical exam) third-space fluid collections,
             for example, ascites or pleural effusions that cannot be controlled by drainage or
             other procedures prior to study entry

          7. Significant weight loss (greater than 10%), over the previous 6 weeks before study
             entry

          8. Concurrent administration of any other antitumor therapy

          9. Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a
             5-day period (8-day period for long-acting agents such as piroxicam)

         10. Inability or unwillingness to take folic acid, dexamethasone (or equivalent) or
             vitamin B12 supplementation

         11. Pregnancy or breast-feeding

         12. You are allergic to pemetrexed