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Table 1 Study inclusion and exclusion criteria

From: Home administration of maintenance pemetrexed for patients with advanced non-squamous non-small cell lung cancer: rationale, practicalities and phase II feasibility study design

Inclusion criteria Willing to comply with home delivery administration and have family or close environment support willing to comply with home delivery administration
  Histological or cytological diagnosis of non-squamous NSCLC
Stage IIIB (not amenable to curative treatment) or IV NSCLC prior to induction therapy [21]
Completed and not progressed after four induction cycles of platinum-based doublet therapy (type at the discretion of the physician). Documented radiographic evidence of a tumour response must occur at the end of Cycle 4 of induction therapy within 3 weeks before receiving the first cycle of study drug (RECIST version 1.1) [20]
Received on-study treatment no earlier than 21 days and no later than 42 days from Cycle 4 Day 1 of induction therapy
ECOG performance status 0 or 1 [19]
Prior radiation therapy is allowed if to <25% of the bone marrow (but not whole pelvis radiation) and the patient has recovered from all toxicities (except for alopecia) before enrolment
Adequate organ function (bone marrow reserve, hepatic, renal)
Aged ≥18 years at time of screening
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
Estimated life expectancy ≥12 weeks
Signed informed consent before any study-specific procedures
Exclusion criteria Squamous cell NSCLC
Current or prior (within last 30 days) participation in a clinical trial involving an investigational product or non-approved use of a drug or device
Serious concomitant systemic disorder that according to the investigator, would compromise ability to adhere to the protocol
Serious cardiac condition, such as myocardial infarction within 6 months, angina or heart disease (NYHA class III/IV)
Central nervous system malignancy or metastases (screening not required) unless patient is asymptomatic and radiographically stable after local therapy and has been off corticosteroids and/or anticonvulsants for ≥1 week
Concurrent administration of any other anti-tumour therapy
Second primary malignancy that may affect interpretation of results
Inability to interrupt aspirin or other non-steroidal anti-inflammatory agents, other than aspirin ≤1.3 g/day, for a 5-day period (8-day period for long-acting agents)
Inability or unwillingness to take folic acid or vitamin B12 supplementation, or corticosteroids
Pregnant or lactating
  Recent (within 30 days) or concurrent yellow fever vaccination
  1. NSCLC = non-small cell lung cancer; RECIST = Response Evaluation Criteria in Solid Tumors; ECOG = Eastern Cooperative Oncology Group; NYHA = New York Heart Association Class.