Adjuvant Cisplatin With Either Genomic-Guided Vinorelbine or Pemetrexed for Early Stage Non-Small-Cell Lung Cancer
Status:
Terminated
Trial end date:
2012-01-01
Target enrollment:
Participant gender:
Summary
This study assigned subjects to either cisplatin/vinorelbine or cisplatin/pemetrexed
chemotherapy using a genomic based expression profile to determine chemotherapy sensitivity
in completely resected early stage non-squamous non-small-cell lung cancer (NSCLC). The
vinorelbine-sensitive tumors group received Vinorelbine followed by cisplatin, while the
pemetrexed-sensitive tumors group received pemetrexed followed by cisplatin. The primary
objective of this trial was to determine whether genomic-based adjuvant chemotherapy
treatment increased the 2-year progression-free survival rate in completely resected patients
with NSCLC compared to historic controls. Secondary objectives included: 1) estimation of the
percentage of completely resected NSCLC tumors that can be adequately analyzed and used to
direct specific adjuvant chemotherapy; 2) estimation of the proportion of patients who are
assigned to treatment with vinorelbine and pemetrexed; 3) evaluation of drug sensitivity
patterns of cisplatin and pemetrexed in both treatment arms; 4) description of the overall
median survival experience of treated patients; and 5) assessment of patient understanding
and perceptions of participating in a clinical trial evaluating cancer genomics for adjuvant
treatment of early stage lung cancer.