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 |