A Study of Home Administration of Pemetrexed as Maintenance Treatment for Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC)
Condition: Nonsquamous Non-Small Cell Neoplasm of Lung; Non-Small Cell Lung Cancer Metastatic; Non-Small Cell Lung Cancer Stage IIIB
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Pemetrexed
Intervention description: Administered intravenously
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose for this study is to answer the following research questions:

        -  Can pemetrexed be administered safely at the participant's home, using the same
           treatment procedure as in a hospital setting?

        -  Will the participant be satisfied with home care?

        -  How might this impact the participant's quality of life?

        -  What are the required medical resources needed to give pemetrexed in a home setting?
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a histological or cytological diagnosis of NSCLC defined as nonsquamous cell
             histology. Squamous cell and/or small cell histology is not permitted. Mixed NSCLC
             tumors will be categorized by the predominant cell type. NSCLC tumors that are not
             otherwise specified with regard to histology or cannot be subclassified as squamous,
             adenocarcinoma, or large cell histology will be categorized as nonsquamous

          -  Have Stage IIIB (not amenable to curative treatment) or Stage IV NSCLC prior to
             induction therapy as defined by the American Joint Committee on Cancer (AJCC) Staging
             Criteria for Lung Cancer

          -  Have completed 4 induction cycles of platinum-based doublet therapy (type at the
             discretion of the physician) for treatment of their advanced disease.

          -  Have not progressed after 4 cycles of induction therapy. Documented radiographic
             evidence of a tumor response must occur at the end of Cycle 4 of induction therapy
             within 3 weeks before receiving the first cycle of study drug [see Response Evaluation
             Criteria in Solid Tumors (RECIST), version (v) 1.1]

          -  Receive on-study treatment no earlier than 21 days and no later than 42 days from
             Cycle 4 Day 1 of induction therapy

          -  Have a Performance Status (PS) of 0 or 1 on the Eastern Cooperative Oncology Group
             (ECOG) scale

          -  Meet the following guidelines if the participant has received prior radiation therapy:

               -  Previous radiation therapy is allowed to <25% of the bone marrow, but should have
                  been limited and must not have included whole pelvis radiation

               -  Participants must have recovered from the toxic effects of the treatment prior to
                  study enrollment (except for alopecia)

               -  Participants who received palliative chest (in other words, thoracic skeleton
                  including dorsal spine) or palliative extrathoracic radiotherapy to preexisting
                  lesions are allowed to be enrolled in this trial

          -  Have adequate organ function, including:

               -  Adequate bone marrow reserve: absolute neutrophil count (ANC) (segmented and
                  bands) >=1.5x109/Liter (L), platelets >=100x109/L, and hemoglobin >=9 grams per
                  deciliter (g/dL)

               -  Hepatic: bilirubin <=1.5 x upper limit of normal (ULN) and alkaline phosphatase
                  (ALP), aspartate aminotransferase (AST), and alanine aminotransferase (ALT) <=3.0
                  x ULN (ALP, AST, and ALT <=5.0 x ULN are acceptable if the liver has tumor
                  involvement

               -  Renal: calculated creatinine clearance (CrCl) >=45 milliliters per minute
                  (mL/min) based on the original weight-based Cockcroft and Gault formula

          -  Are willing to comply with the following contraceptive criteria:

               -  Females must be surgically sterile, postmenopausal or must have a negative serum
                  or urine pregnancy test within 7 days prior to the first dose of study drug

               -  Males and females with reproductive potential: Must agree to use a reliable
                  method of birth control during the study and for 6 months following the last dose
                  of study drug

          -  Have an estimated life expectancy of at least 12 weeks

          -  Have given written informed consent/assent prior to any study-specific procedures

          -  Are willing to comply with home delivery administration and have family or close
             environment support willing to comply with home delivery administration

        Exclusion Criteria:

          -  Are currently enrolled in, or discontinued within the last 30 days from, a clinical
             trial involving an investigational product or no approved use of a drug or device
             (other than pemetrexed used in this study), or concurrently enrolled in any other type
             of medical research judged not to be scientifically or medically compatible with this
             study

          -  Have previously completed or withdrawn from this study

          -  Have a serious concomitant systemic disorder (for example, active infection including
             human immunodeficiency virus)

          -  Have a serious cardiac condition, such as myocardial infarction within 6 months,
             angina, or heart disease, as defined by the New York Heart Association Class III or IV

          -  Have symptomatic central nervous system (CNS) malignancy or metastasis (screening not
             required). Participants with treated CNS metastases are eligible for this study if
             they are not currently receiving corticosteroids and/or anticonvulsants for at least 1
             week before starting study treatment and their disease is asymptomatic and
             radiographically stable

          -  Are receiving concurrent administration of any other antitumor therapy

          -  Have a second primary malignancy that in the judgment of the investigator and sponsor
             may affect the interpretation of results

          -  Are unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents, other
             than aspirin dose ≤1.3 grams per day, for a 5-day period (8-day period for long-acting
             agents, such as piroxicam)

          -  Are unable or unwilling to take folic acid or vitamin B12 supplementation

          -  Are unable or unwilling to take corticosteroids

          -  Are pregnant or lactating

          -  Have received a recent (within 30 days of enrollment) or are receiving concurrent
             yellow fever vaccination