Randomized Phase II Study of Pemetrexed and Cisplatin as Either Induction or Adjuvant Chemotherapy in Stage IB-II Non-Small Cell Lung Cancer (NSCLC)
- Compare the tolerability (in terms of drug delivery and toxicity) of neoadjuvant vs
adjuvant chemotherapy comprising cisplatin and pemetrexed disodium in patients with
resectable stage IB or II non-small cell lung cancer.
- Determine the overall toxicity of this regimen in these patients.
- Determine the progression-free and overall survival of patients treated with this
- Determine the overall clinical response rate, pathologic complete response, and
resectability rate in patients treated with neoadjuvant chemotherapy.
- Determine the surgical morbidity and mortality of patients treated with these regimens.
- Determine the fraction of patients in the adjuvant arm that receives chemotherapy.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to institution, histological subtype (squamous vs nonsquamous) and clinical stage
(IB vs II). Patients are randomized to 1 of 2 treatment arms.
- Arm I (neoadjuvant chemotherapy): Patients receive cisplatin IV over 3-6 hours and
pemetrexed disodium IV on day 1. Treatment repeats every 21 days for up to 3 courses in
the absence of disease progression or unacceptable toxicity. Four to six weeks after
completion of chemotherapy, patients undergo surgery.
- Arm II (adjuvant chemotherapy): Patients undergo surgery. Beginning 4-8 weeks after
surgery, patients receive cisplatin and pemetrexed disodium as in arm I.
After completion of study treatment, patients are followed periodically for 5 years and then
PROJECTED ACCRUAL: A total of 132 patients will be accrued for this study.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Successful treatment delivery
Paul Germonpre, MD
Universitair Ziekenhuis Antwerpen
United States: Federal Government