NCT01593293.

Trial name or title	A randomized, Open‐Label, Phase III Study Comparing Pemetrexed With and Without Carboplatin in Elderly Patients With Advanced Non‐Squamous Non‐Small Cell Lung Cancer
Methods	Randomized multi‐center open‐label
Participants	Eligibility criteria Inclusion criteria Histologically confirmed advanced non‐squamous non‐small cell lung cancer (stage IV, American Joint Committee on Cancer (AJCC) 7) ≥ 70 years of age Eastern Cooperative Oncology Group performance status 0 to 1 Measurable or assessable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 Estimated life expectancy > 3 months Adequate bone marrow function (absolute neutrophil count (ANC) ≥ 1500/µL, platelets ≥ 100,000/µL, hemoglobins ≥ 9 g/dL) Adequate renal function: creatinine < 1 × upper normal limit (UNL) or creatinine clearance (Ccr) using Cockroft and Gault formula ≥ 45 mL/min Adequate hepatic function: bilirubin < 1.5 × upper normal limit (UNL), aspartate amino transferase (AST)/amino alanine transferase (ALT) levels < 3 × UNL, alkaline phosphatase < 3 × UNL (except in case of bone metastasis without liver disease) Written informed consent Exclusion criteria Prior systemic chemotherapy or biological therapy Contraindication to any drug contained in the chemotherapy regimen Clinically significant third‐space fluid collections (e.g. pleural effusion, pericardial effusion) that cannot be controlled by drainage or other procedures before study enrolment Active infection that would compromise the patient's ability to tolerate treatment Requirement for major surgery within 4 weeks of study entry Myocardial infarction, uncontrolled arrhythmia, symptomatic angina pectoris, cardiac failure within previous 6 months Unable to discontinue administration of aspirin or other non‐steroidal anti‐inflammatory drugs (NSAIDs); aspirin or NSAIDs should be discontinued ≥ 5 days before pemetrexed administration Presence or history of central nervous system (CNS) metastasis (except if adequately treated and not receiving steroid therapy for ≥ 2 weeks; ≥ 2 weeks for whole brain radiation or ≥ 1 week for gamma knife surgery) Peripheral neuropathy ≥ grade 2 History of another malignancy within past 5 years, except cured basal cell carcinoma of skin, cured carcinoma in situ of uterine cervix, and cured thyroid malignancy Pregnant or lactating women, women of childbearing potential not employing adequate contraception Other serious illness or medical condition
Interventions	Control arm: pemetrexed 500 mg/m2 on day 1, every 3 weeks until progression or unacceptable toxicity Experimental arm: pemetrexed 500 mg/m2 on day 1 plus carboplatin AUC5 i.v. on day 1, every 3 weeks for 4 cycles, followed by pemetrexed 500 mg/m2 on day 1, every 3 weeks for maintenance therapy
Outcomes	Primary outcome Progression‐free survival Secondary outcomes Objective response rate Overall survival Safety Quality of life using Functional Assessment of Cancer Therapy‐Lung (FACT‐L) questionnaire
Starting date	March 2012
Contact information	Sang‐We Kim, M.D.; 82‐2‐3010‐3215; email: swkim@amc.seoul.kr
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