Conditions: Non-Small Cell Lung Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 70
Healthy volunteers: no

Brief summary:
Thymidylate synthase (TS) is a substance the body produces naturally. The purpose of this research is to determine if there is a link between TS production and how well patients respond to treatment of non-squamous non-small cell lung cancer (NSCLC). The aim for the future is that doctors could have a better understanding in advance about which patients might respond well to pemetrexed based on how much TS they produce.

Detailed description:
All patients on this study will receive 4 intravenous injections of the chemotherapy drugs pemetrexed and cisplatin (with each injection approximately 3 weeks apart). Patients who complete 4 such injections and respond well to their treatment may continue to receive an injection of chemotherapy drug pemetrexed (approximately every 3 weeks). In general terms, treatment will last until either the patient or the doctor decides that there is no clear benefit in continuing with the treatment.

TS levels will be measured from the tumour sample used to make the original diagnosis of NSCLC.

Arms:
arm 1: None

Interventions: intervention 1: pemetrexed intervention 2: cisplatin
Intervention descriptions: intervention 1: Induction Therapy: 500 milligrams per square meter (mg/m\^2), intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: 500 milligrams per square meter (mg/m\^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs intervention 2: Induction Therapy: 75 mg/m\^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles

Protocol document: