Advanced nonsquamous Non-small Cell Lung Cancer MedDRA version: 15.0 Level: LLT Classification code 10025054 Term: Lung cancer non-small cell stage IIIB System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 15.0 Level: LLT Classification code 10025055 Term: Lung cancer non-small cell stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Alimta
Product Name: pemetrexed
Product Code: LY231514
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: Pemetrexed
CAS Number: 357166-29-1
Current Spo
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must have a histological or cytological diagnosis of Stage IIIB or Stage IV NSCLC defined as nonsquamous cell histology. Patients must be at least 18 years of age Patients must have completed 4 induction cycles of platinum based doublet therapy (type at the discretion of the physician) and not progressed after induction therapy. Have adequate organ function Are willing to comply with the following contraceptive criteria Have an estimated life expectancy of at least 12 weeks Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 45 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: Have a serious concomitant systemic disorder Have a serious cardiac condition Are receiving concurrent administration of any other antitumor therapy Are unable to interrupt aspirin or other nonsteroidal anti-inflammatory agents Have received a recent (within 30 days of enrollment) or are receiving concurrent yellow fever vaccination Have a second primary malignancy that in the judgment of the investigator and sponsor may affect the interpretation of results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the adherence rate to pemetrexed administered in a domiciliary setting.;Secondary Objective: To assess resource utilization: distances traveled; number/length of visits; unplanned use of healthcare resources (ie, primary care, emergency, hospitalizations). To assess quality of life (QoL) and satisfaction with home care and time to treatment failure (TTF) and overall survival (OS);Primary end point(s): Adherence to treatment administration at home;Timepoint(s) of evaluation of this end point: Starting at Day 1 of Cycle 1 until reversal to hospital administration or discontinuation from the study due to the domiciliary setting. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Time to treatment failure Overall survival QoL Patient satisfaction Resource utilisation;Timepoint(s) of evaluation of this end point: Time to treatment failure: The time from the date of first dose of study treatment to the date of death from any cause, PD or discontinuation of pemetrexed due to toxicity. Overall surival: The time from the date of the first dose of study treatment to the date of death from any cause. For patients not known to have died as of the cut off date, OS will be censored as the last contact date. QoL: The EQ-5D and patient LCSS will be completed at baseline, day 1 of each cycle and at the 30 day postdiscontinuation visit. Patient Satisfaction: to be conducted at the end of the study for all patients and on the day of infusion of cycle 4 for those patients who receive at least 4 maintenance cycles. Resource Utilisation: To be completed at different timepoints of each cycle. | — |
Countries
Sweden, United Kingdom
Outcome results
None listed