Know Cancer

forgot password

Home Delivery of Pemetrexed as Maintenance Treatment in Patients Who Have Not Progressed After Induction Therapy for Advanced Nonsquamous Nonsmall Cell Lung Cancer: A Feasibility Study

Phase 2
18 Years
Open (Enrolling)
Nonsquamous Nonsmall Cell Neoplasm of Lung, Non-small Cell Lung Cancer Metastatic, Non-small Cell Lung Cancer Stage IIIB

Thank you

Trial Information

Home Delivery of Pemetrexed as Maintenance Treatment in Patients Who Have Not Progressed After Induction Therapy for Advanced Nonsquamous Nonsmall Cell Lung Cancer: A Feasibility Study

Inclusion Criteria:

- Have a histological or cytological diagnosis of Nonsmall Cell Lung Cancer (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 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

- 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 (i.e. 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/L, platelets >=100x109/L, and hemoglobin >=9 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

- Renal: calculated creatinine clearance (CrCl) >=45 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Proportion of participants who adhere to treatment administration at home

Outcome Time Frame:

Day 1 of Cycle 1 to date participant reverts to infusions in the hospital or discontinues due to the home setting (estimated at 9 months)

Safety Issue:


Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company


Sweden: Medical Products Agency

Study ID:




Start Date:

December 2011

Completion Date:

September 2013

Related Keywords:

  • Nonsquamous Nonsmall Cell Neoplasm of Lung
  • Non-small Cell Lung Cancer Metastatic
  • Non-small Cell Lung Cancer Stage IIIB
  • Neoplasms
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neoplasms, Second Primary