A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Following 4 Cycles of Platinum-based Chemotherapy Without Disease Progression

Arms (1)

1. type

   EXPERIMENTAL

   label

   Erlotinib

   description

   Participants received erlotinib 150 mg orally once a day for 48 weeks.

   interventionNames

   1. Drug: Erlotinib

Primary outcomes (1)

1. measure

   Percentage of Participants With Progression-free Survival at Week 52

   timeFrame

   From the date of enrolment in the study until the date of disease progression or death from any cause (up to 2 years, 6 months).

   description

   A participant had progression-free survival if they did not have disease progression and were alive. Tumor assessments were done by magnetic resonance imaging according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. Disease progression was defined as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started or the unequivocal progression of existing non-target lesions. All measurable lesions up to a maximum of 2 lesions per organ and 5 lesions in total, representative of all involved organs, should be identified as target lesions at Baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repeated measurements (either by imaging techniques or clinically). A sum of the longest diameter for all target lesions will be calculated and reported as the Baseline sum longest diameter.