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
The treatment of NSCLC in elderly has been subject to discussion for years. While platinum
doublets consisting of cisplatin or carboplatin and another cytotoxic agent demonstrate a
survival advantage compared with single agents generally, evidence of treatment efficacy for
patients with diminished performance status (PS) or with age older than 70 years is limited.
Guidelines from the US and Europe have preferred single-agent chemotherapy for the elderly
and PS 2 patients. However, increasing studies are exploring this issue and presenting data
that favour doublet therapy. The addition of carboplatin to paclitaxel and cisplatin to
docetaxel have shown evidence that patients over 70 benefit more in face of increased
This study is designed to be multi-center, open-label, prospective, randomized, two-arm,
parallel, phase III trial of elderly patients(≥70 years old) with metastatic non-squamous
NSCLC (Stage IV by AJCC 7th) who have not received prior systemic chemotherapy or biological
therapy. Approximately 266 patients will be enrolled into the trial. This study compares the
doublet therapy of pemetrexed (500 mg/m2) and carboplatin (AUC 5 mg/mL*min) administered
intravenously every 21 days for 4 cycles followed by pemetrexed (500 mg/m2) every 21 days
for maintenance therapy (Arm A) to single therapy of pemetrexed (500 mg/m2) every 21 days
till progression or unacceptable toxicity (Arm B). Pemetrexed will be administered with
vitamin B12 and folate supplements.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression free survival
To compare the progression free survival of elderly patients (≥70 years old) with non-squamous NSCLC receiving doublet of carboplatin and pemetrexed to patients receiving pemetrexed alone.
The study lasts for 30 months of which subject accrual occurs in the first 24 months
Sang-We Kim, M.D.
Asan Medical Center
Korea: Food and Drug Administration