Carcinoma, Non Small Cell Lung
Conditions
Interventions
investigational material(s)
Generic name etc : Gefitinib-pemetrexed combination
INN of investigational material : Gefitinib, Pemetrexed
Therapeutic category code : 429 Other antitumor agents
Dosage an
Sponsors
Eli Lilly Japan K.K.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Histologically or cytologically confirmed advanced (Stage IV) or recurrent non-squamous NSCLC. -Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1. -The participant's primary NSCLC tumor has an activating Epidermal Growth Factor Receptor (EGFR) mutation, as determined by any validated method. -The participant has measurable disease at the time of study entry. -The participant has not had any prior systemic chemotherapy, immunotherapy, or biological therapy (for example, targeted therapy, such as erlotinib or gefitinib) for Stage IV or recurrent non-squamous NSCLC. -The participant has adequate organ function(hematopoietic function, liver function, renal function). -The participant is able to take folic acid, vitamin B12, and dexamethasone, according to the protocol's requirements. -Prior radiation therapy is allowed to <25% of the bone marrow.
Exclusion criteria
Exclusion criteria: -The participant is receiving concurrent treatment with any other anticancer therapy. -The participant has untreated central nervous system (CNS) metastases. -The participant has a serious illness or medical condition that would compromise their safety or impair their ability to comply with the protocol's requirements. -Are unable to interrupt aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs), other than an aspirin dose equal to or less than 1.3 grams per day, for at least 2 days (5 days for long-acting agents [for example, piroxicam]) before, during, and for at least 2 days after administration of pemetrexed. -Concomitant use of cytochrome P450 (CYP)3A4 inducers or CYP3A4 inhibitors. -Any known significant ophthalmologic abnormalities of the surface of the eye. The use of contact lenses is not recommended during the study. -The participant has previously received treatment with gefitinib, erlotinib or pemetrexed. -Any evidence of clinically active interstitial lung disease. -The participant is pregnant or breastfeeding.
Outcome results
None listed