{"denoms":[{"counts":[{"groupId":"BG000","value":"73"},{"groupId":"BG001","value":"71"},{"groupId":"BG002","value":"144"}],"units":"Participants"}],"groups":[{"description":"Pembrolizumab is administrated at 200 mg fixed dose i.v. on day 1 of every 3 week cycle for a maximum or 2 years (expected maximum of 36 doses), or until progression of disease determined according to RECIST 1.1 criteria or lack of tolerability, or until the patient declines further treatment.\n\nPembrolizumab: Pembrolizumab (MK-3475) is a potent and highly selective humanised monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This blockade enhances functional activity of the target lymphocytes to facilitate tumour regression and ultimately immune rejection.","id":"BG000","title":"Pembrolizumab Arm"},{"description":"Gemcitabine (i.v. 1000 mg/m2) or vinorelbine (i.v. 30 mg/m2, or p.o 60/80 mg/m2) chemotherapy will be chosen on a per patient basis and delivered according to local standards. Chemotherapy will be administered on days 1 and 8 of every 3-week cycle. A maximum number of treatment cycles is not mandated.\n\nPatients randomised to the control arm will be allowed to cross over to receive pembrolizumab at progression, if cross-over criteria are met. Pembrolizumab administration will follow the same schedule as for patients in the experimental arm, i.e. 200 mg fixed dose i.v. on day 1 of every 3-week cycle for a maximum of 2 years or until trial termination.\n\nGemcitabine: Gemcitabine replaces one of the building blocks of nucleic acids, in this case cytidine, during DNA replication. The process arrests tumour growth, as new nucleosides cannot be attached to the \"faulty\" nucleoside, resulting in apoptosis (cellular \"suicide\").\n\nVinorelbine: Vinorelbine is a vinca alkaloid cytotoxic chemotherapy that is available in intravenous and oral preparations with EMA licenses in lung cancer and breast cancer. Vinorelbine blocks mitosis in phase G2-M, causing cell death in interphase or at the following mitosis.","id":"BG001","title":"Standard Chemotherapy Arm"},{"description":"Total of all reporting groups","id":"BG002","title":"Total"}],"measures":[{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","lowerLimit":"52.0","upperLimit":"83.0","value":"69.0"},{"groupId":"BG001","lowerLimit":"53.0","upperLimit":"83.0","value":"71.0"},{"groupId":"BG002","lowerLimit":"52.0","upperLimit":"83.0","value":"70.0"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"73"},{"groupId":"BG001","value":"71"},{"groupId":"BG002","value":"144"}],"units":"Participants"}]}],"dispersionType":"FULL_RANGE","paramType":"MEDIAN","title":"Age, Continuous","unitOfMeasure":"years"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"42"},{"groupId":"BG001","value":"29"},{"groupId":"BG002","value":"71"}],"title":"<70 years"},{"measurements":[{"groupId":"BG000","value":"31"},{"groupId":"BG001","value":"42"},{"groupId":"BG002","value":"73"}],"title":"≥70 years"}],"denoms":[{"counts":[{"groupId":"BG000","value":"73"},{"groupId":"BG001","value":"71"},{"groupId":"BG002","value":"144"}],"units":"Participants"}],"title":"Age category"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Age, Customized","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"15"},{"groupId":"BG001","value":"11"},{"groupId":"BG002","value":"26"}],"title":"Female"},{"measurements":[{"groupId":"BG000","value":"58"},{"groupId":"BG001","value":"60"},{"groupId":"BG002","value":"118"}],"title":"Male"}],"denoms":[{"counts":[{"groupId":"BG000","value":"73"},{"groupId":"BG001","value":"71"},{"groupId":"BG002","value":"144"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Sex: Female, Male","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG002","value":"0"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Race and Ethnicity were not collected from any participant.","title":"Race and Ethnicity Not Collected","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"54"},{"groupId":"BG001","value":"53"},{"groupId":"BG002","value":"107"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"73"},{"groupId":"BG001","value":"71"},{"groupId":"BG002","value":"144"}],"units":"Participants"}],"title":"United Kingdom"},{"categories":[{"measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"27"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"73"},{"groupId":"BG001","value":"71"},{"groupId":"BG002","value":"144"}],"units":"Participants"}],"title":"Switzerland"},{"categories":[{"measurements":[{"groupId":"BG000","value":"6"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"10"}]}],"denoms":[{"counts":[{"groupId":"BG000","value":"73"},{"groupId":"BG001","value":"71"},{"groupId":"BG002","value":"144"}],"units":"Participants"}],"title":"Spain"}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Region of Enrollment","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"66"},{"groupId":"BG001","value":"62"},{"groupId":"BG002","value":"128"}],"title":"Epithelioid"},{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"9"},{"groupId":"BG002","value":"16"}],"title":"Non-epithelioid"}],"denoms":[{"counts":[{"groupId":"BG000","value":"73"},{"groupId":"BG001","value":"71"},{"groupId":"BG002","value":"144"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Histologic subtype","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"5"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"9"}],"title":"Current"},{"measurements":[{"groupId":"BG000","value":"34"},{"groupId":"BG001","value":"28"},{"groupId":"BG002","value":"62"}],"title":"Former (≥100 cigarettes in the past during the whole life)"},{"measurements":[{"groupId":"BG000","value":"33"},{"groupId":"BG001","value":"39"},{"groupId":"BG002","value":"72"}],"title":"Never (0-99 cigarettes during the whole life)"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}],"title":"Unknown/Missing"}],"denoms":[{"counts":[{"groupId":"BG000","value":"73"},{"groupId":"BG001","value":"71"},{"groupId":"BG002","value":"144"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Smoking history","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"21"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"35"}],"title":"0"},{"measurements":[{"groupId":"BG000","value":"51"},{"groupId":"BG001","value":"57"},{"groupId":"BG002","value":"108"}],"title":"1"},{"measurements":[{"groupId":"BG000","value":"1"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"1"}],"title":"2"}],"denoms":[{"counts":[{"groupId":"BG000","value":"73"},{"groupId":"BG001","value":"71"},{"groupId":"BG002","value":"144"}],"units":"Participants"}]}],"description":"0: Fully active, able to carry on all pre-disease performance without restriction; 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2: Ambulatory and capable of all selfcare but unable to carry out any work activities, up and about more than 50% of waking hours.\n\nOf note, although an ECOG performance status (PS) of 0 or 1 was mandatory to be included in the study, one patient was allowed to enter the study with ECOG PS of 2 due to leg braces.","paramType":"COUNT_OF_PARTICIPANTS","title":"ECOG performance status","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"45"},{"groupId":"BG001","value":"54"},{"groupId":"BG002","value":"99"}],"title":"Good prognosis"},{"measurements":[{"groupId":"BG000","value":"28"},{"groupId":"BG001","value":"17"},{"groupId":"BG002","value":"45"}],"title":"Poor prognosis"}],"denoms":[{"counts":[{"groupId":"BG000","value":"73"},{"groupId":"BG001","value":"71"},{"groupId":"BG002","value":"144"}],"units":"Participants"}]}],"description":"EORTC prognostic score (EPS) was calculated based on Fennell et al.(2005) prognostic model. This model takes into account WBC count, ECOG PS, histologic subtype and gender. A value of smaller or equal to 1.27 signifies a \"good prognosis\" while a value of more than 1.27 a \"poor prognosis\".","paramType":"COUNT_OF_PARTICIPANTS","title":"EORTC score","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"27"},{"groupId":"BG001","value":"27"},{"groupId":"BG002","value":"54"}],"title":"Carboplatin/Pemetrexed"},{"measurements":[{"groupId":"BG000","value":"24"},{"groupId":"BG001","value":"22"},{"groupId":"BG002","value":"46"}],"title":"Cisplatin/Pemetrexed"},{"measurements":[{"groupId":"BG000","value":"13"},{"groupId":"BG001","value":"17"},{"groupId":"BG002","value":"30"}],"title":"Platinum+/-Pemetrexed+/-Other"},{"measurements":[{"groupId":"BG000","value":"7"},{"groupId":"BG001","value":"1"},{"groupId":"BG002","value":"8"}],"title":"Cisplatin/Pemetrexed and Carboplatin/Pemetrexed"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"6"}],"title":"Missing"}],"denoms":[{"counts":[{"groupId":"BG000","value":"73"},{"groupId":"BG001","value":"71"},{"groupId":"BG002","value":"144"}],"units":"Participants"}]}],"paramType":"COUNT_OF_PARTICIPANTS","title":"Prior treatment","unitOfMeasure":"Participants"},{"classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"36"},{"groupId":"BG001","value":"30"},{"groupId":"BG002","value":"66"}],"title":"<1%"},{"measurements":[{"groupId":"BG000","value":"20"},{"groupId":"BG001","value":"18"},{"groupId":"BG002","value":"38"}],"title":"1-20%"},{"measurements":[{"groupId":"BG000","value":"11"},{"groupId":"BG001","value":"14"},{"groupId":"BG002","value":"25"}],"title":"≥20%"},{"measurements":[{"groupId":"BG000","value":"2"},{"groupId":"BG001","value":"4"},{"groupId":"BG002","value":"6"}],"title":"Not evaluable"},{"measurements":[{"groupId":"BG000","value":"4"},{"groupId":"BG001","value":"5"},{"groupId":"BG002","value":"9"}],"title":"Not scored"}],"denoms":[{"counts":[{"groupId":"BG000","value":"73"},{"groupId":"BG001","value":"71"},{"groupId":"BG002","value":"144"}],"units":"Participants"}]}],"description":"PD-L1 expression (PD-L1 tumor proportion score) was evaluated by immunohistochemistry (IHC) assay using clone SP263. PD-L1 was quantified as number of positive cells and scored as percentage of PD-L1 positive cells within tumor region. The following classification of PD-L1 scoring was used: 0 to \\<1% positive tumor cells; 1 to \\<20% positive tumor cells; \\>=20% positive tumor cells; Not Evaluable; Not scored.","paramType":"COUNT_OF_PARTICIPANTS","title":"PD-L1 Tumour proportion score","unitOfMeasure":"Participants"}]}