{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"2.3"},{"groupId":"OG001","value":"0"}]}],"title":"Complete Response (CR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"62.8"},{"groupId":"OG001","value":"16.1"}]}],"title":"Partial Response (PR)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"18.6"},{"groupId":"OG001","value":"49.4"}]}],"title":"Stable Disease (SD)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"7"},{"groupId":"OG001","value":"12.6"}]}],"title":"Progressive Disease (PD)"},{"categories":[{"measurements":[{"groupId":"OG000","value":"9.3"},{"groupId":"OG001","value":"21.8"}]}],"title":"Missing (No Response Assessment)"}],"denoms":[{"counts":[{"groupId":"OG000","value":"86"},{"groupId":"OG001","value":"87"}],"units":"Participants"}],"description":"The objective response rate is defined as the percentage of patients who attain complete response (CR) or partial response (PR); response will be evaluated following RECIST criteria version 1.0.\n\nResponse Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \\>=30% decrease in the sum of the longest diameter of target lesions; Progressive disease (PD): at least a 20% increase in the sum of diameters of target lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum of diameters recorded on study.","groups":[{"description":"Erlotinib (Tarceva)150 mg /day\n\nPatients will receive treatment until disease progression or unacceptable toxicity.\n\nFor all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib\n\nErlotinib: 150 mg/day Patients will receive treatment until disease progression or unacceptable toxicity.\n\nFor all practical effects a treatment cycle will be defined as three weeks of continuous treatment with erlotinib","id":"OG000","title":"A: Erlotinib Group"},{"description":"4 cycles of Chemotherapy:\n\nCisplatin / Gemcitabine; Cisplatin /Docetaxel; Carboplatin / Gemcitabine; Carboplatin / Docetaxel.\n\n3 week cycles of standard intravenous chemotherapy\n\n* 75 mg/m² cisplatin plus 75 mg/m² docetaxel on day 1 or\n* 75 mg/m² cisplatin on day 1 plus 1250 mg/m² gemcitabine on days 1 and 8\n\nPatients who were ineligible for cisplatin treatment received intra venous carboplatin chemotherapy instead:\n\n* 3 week cycles of carboplatin AUC 6 on day 1 with 75 mg/m² docetaxel on day 1 or\n* 3 week cycles carboplatin AUC 5 on day 1 with 1000 mg/m² gemcitabine on days 1 and 8\n\nPatients in the chemotherapy arm will receive the treatment until disease progression or unacceptable toxicity occurs, or until a maximum of 4 treatment cycles are given.","id":"OG001","title":"B: Standard Chemotherapy Group"}],"paramType":"NUMBER","reportingStatus":"POSTED","timeFrame":"From the date of randomization to the date of last follow up, assessed up to 24 months","title":"Objective Response","type":"SECONDARY","unitOfMeasure":"percentage of participants"}