A Study of Pemetrexed/Cisplatin as Pre-operative Treatment of Early Stage Nonsquamous Non-Small Cell Lung Cancer
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Pemetrexed; Cisplatin; Folic Acid; Vitamin B12; Dexamethasone
Intervention description: 500 milligram per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles; 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles; Administered orally.; Administered Intramuscular injection.; Administered orally.
Intervention MeSH terms: Folic Acid; Vitamin B 12; Dexamethasone; Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 19.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to assess how well the combination of pemetrexed with cisplatin
      can reduce tumor size.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Nonsquamous Non-Small Cell Lung Cancer that was confirmed by tissue biopsy

          -  Stage IIIAN2 disease (T1aN2, T1bN2, T2aN2, T2bN2, and T3N2)

          -  Tumor considered potentially resectable

          -  Good performance status (score of 0 or 1) according to Eastern Cooperative Oncology
             Group scale (ECOG)

          -  No prior therapy for lung cancer

          -  Measurable disease according to version 1.1 of Response Evaluation Criteria in Solid
             Tumors (RECIST) Criteria

          -  Life expectancy of at least 6 months

          -  Organs are functioning well (bone marrow reserve, liver, kidney, lung)

          -  Signed Informed Consent

          -  Women must be surgically sterile, postmenopausal, or compliant with a medically
             approved contraceptive regimen (for example, intrauterine device, birth control pills,
             or barrier device) during and for 6 months after last dose of study drug; must have a
             negative pregnancy test within 7 days before study enrollment; and must not be
             breast-feeding.

          -  Men must be surgically sterile, or compliant with a contraceptive regimen during and
             for 6 months after last dose of study drug.

          -  Be fit for surgery at the time of enrollment

        Exclusion Criteria:

          -  Receiving or have received an investigational drug or device within the last 30 days

          -  Have previously completed or withdrawn from this study or any other study
             investigating pemetrexed

          -  Serious concomitant systemic disorder

          -  Serious cardiac condition, such as myocardial infarction within 6 months, angina, or
             heart disease

          -  Receiving concurrent administration of any other anticancer therapy

          -  Have received a recent (within 30 days of enrollment) or are receiving concurrent
             yellow fever vaccination

          -  Inability or unwillingness to take Pemetrexed supplementation/premedication (folic
             acid, vitamin B12, or corticosteroids)

          -  Inability to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other
             than an aspirin dose less than or equal to 1.3 grams per day