{"denoms":[{"counts":[{"groupId":"BG000","value":"86"},{"groupId":"BG001","value":"87"},{"groupId":"BG002","value":"173"}],"units":"Participants"}],"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":"BG000","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":"BG001","title":"B: Standard Chemotherapy Group"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"53","upperLimit":"82","value":"65"},{"groupId":"BG001","lowerLimit":"46","upperLimit":"82","value":"65"},{"groupId":"BG002","lowerLimit":"46","upperLimit":"82","value":"65"}]}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"58"},{"groupId":"BG001","value":"68"},{"groupId":"BG002","value":"126"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"19"},{"groupId":"BG002","value":"47"}],"title":"Male"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"American Indian or Alaska Native"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Asian"},{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"title":"Native Hawaiian or Other Pacific 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(NIH/OMB)","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"8"},{"groupId":"BG002","value":"19"}]}],"title":"Italy"},{"categories":[{"measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"39"}]}],"title":"France"},{"categories":[{"measurements":[{"groupId":"BG000","value":"54"},{"groupId":"BG001","value":"61"},{"groupId":"BG002","value":"115"}]}],"title":"Spain"}],"paramType":"NUMBER","title":"Region of Enrollment","unitOfMeasure":"participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"57"},{"groupId":"BG001","value":"63"},{"groupId":"BG002","value":"120"}]}],"title":"Never smoked"},{"categories":[{"measurements":[{"groupId":"BG000","value":"22"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"34"}]}],"title":"Previous smoker"},{"categories":[{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"19"}]}],"title":"Current smoker"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Smoking status","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"30"},{"groupId":"BG002","value":"57"}]}],"title":"ECOG 0"},{"categories":[{"measurements":[{"groupId":"BG000","value":"47"},{"groupId":"BG001","value":"45"},{"groupId":"BG002","value":"92"}]}],"title":"ECOG 1"},{"categories":[{"measurements":[{"groupId":"BG000","value":"12"},{"groupId":"BG001","value":"12"},{"groupId":"BG002","value":"24"}]}],"title":"ECOG 2"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}],"title":"ECOG 3"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}],"title":"ECOG 4"}],"description":"ECOG Performance Status Scale: It describes a patient's level of functioning in terms of their ability to care for themself, daily activity, and physical ability\n\nGRADES:\n\nECOG 0: Fully active. ECOG 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature ECOG 2: Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours ECOG 3: Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours ECOG 4: Completely disabled ECOG 5: Dead","paramType":"COUNT_OF_PARTICIPANTS","title":"ECOG Performance Status Scale","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"82"},{"groupId":"BG001","value":"78"},{"groupId":"BG002","value":"160"}]}],"title":"Adenocarcinoma"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"2"},{"groupId":"BG002","value":"2"}]}],"title":"Bronchoalveolar adenocarcinoma"},{"categories":[{"measurements":[{"groupId":"BG000","value":"3"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"4"}]}],"title":"Large-cell carcinoma"},{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]}],"title":"Squamous-cell carcinoma"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]}],"title":"Pleomorphic carcinoma"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"1"}]}],"title":"Adenosquamous carcinoma"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"4"}]}],"title":"Undifferentiated carcinomas"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Histological diagnosis","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]}],"title":"Stage IIIA"},{"categories":[{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"11"}]}],"title":"Stage IIIB (malignant pleural effusion)"},{"categories":[{"measurements":[{"groupId":"BG000","value":"78"},{"groupId":"BG001","value":"82"},{"groupId":"BG002","value":"160"}]}],"title":"Stage IV"},{"categories":[{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}]}],"title":"Stage II C"}],"description":"Staging is a classification where cancer is located, if or where it has spread and whether it's affecting other parts of the body.\n\nThere are 5 stages for NSCLC:\n\nStage 0:tumor hasn't grown into nearby normal lung tissues Stage I:small tumor that hasn't spread to any lymph nodes Stage II: medium tumor that hasn't spread to the nearby lymph nodes or N1 Stage III: cancer spread to the lymph nodes but haven't spread to other distant parts of the body Stage IV:cancer has spread to more than 1 area in the other lung, the fluid surrounding the lung or the heart, or distant parts of the body","paramType":"COUNT_OF_PARTICIPANTS","title":"Clinical stage","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"29"},{"groupId":"BG002","value":"57"}]}],"title":"Yes"},{"categories":[{"measurements":[{"groupId":"BG000","value":"58"},{"groupId":"BG001","value":"58"},{"groupId":"BG002","value":"116"}]}],"title":"No"}],"description":"Bone metastasis in lung cancer occurs when cancer cells spread from the lungs to the bones. This happens when cancer cells break away from the primary lung tumor, travel through the bloodstream or lymphatic system, and establish new tumors in bone tissue.","paramType":"COUNT_OF_PARTICIPANTS","title":"Bone metastasis","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"9"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"20"}]}],"title":"Yes"},{"categories":[{"measurements":[{"groupId":"BG000","value":"77"},{"groupId":"BG001","value":"76"},{"groupId":"BG002","value":"153"}]}],"title":"No"}],"description":"Brain metastasis in lung cancer occurs when cancer cells from the lungs spread to the brain. This is a common complication in advanced-stage lung cancer, particularly with non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). It happens when cancer cells travel through the bloodstream or lymphatic system and invade brain tissue.","paramType":"COUNT_OF_PARTICIPANTS","title":"Brain metastasis","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"57"},{"groupId":"BG001","value":"58"},{"groupId":"BG002","value":"115"}]}],"title":"Deletion of exon 19"},{"categories":[{"measurements":[{"groupId":"BG000","value":"29"},{"groupId":"BG001","value":"29"},{"groupId":"BG002","value":"58"}]}],"title":"L858R mutation in exon 21"},{"categories":[{"measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]}],"title":"Other"}],"description":"EGFR (epidermal growth factor receptor) mutations in NSCLC types:\n\nExon19 Deletions: It leads to the activation of EGFR contributing to cancer cell growth.\n\nExon21 L858R Mutation: It involves a substitution of leucine for arginine and leads to receptor activation promoting tumor growth.\n\nExon20 Insertion Mutations: Insertion of small amino acid and are often resistant to EGFR inhibitors.\n\nT790M Mutation: Associated with resistance to TKIs. Exon19-21 Complex Mutations: Across exon 19 \\& 21.\n\nTesting for EGFR mutations is crucial for selecting the appropriate therapy in cancer treatment.","paramType":"COUNT_OF_PARTICIPANTS","title":"Type of EGFR mutation","unitOfMeasure":"Participants"}]}