{"groups":[{"description":"Phase II part:\n\nNintedanib matching placebo 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of placebo could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.","id":"FG000","title":"Placebo_Phase II"},{"description":"Phase II part: Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of Nintedanib could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.","id":"FG001","title":"Nintedanib_Phase II"},{"description":"Phase III part: Nintedanib matching Placebo 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of placebo could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.","id":"FG002","title":"Placebo_Phase III"},{"description":"Phase III part: Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule (100 mg or 150 mg capsules) plus standard Pemetrexed 500 mg/m2 (100 mg or 500 mg vials) and Cisplatin 75 mg/m2 (50 mL of 1 mg/ml solution) on Day 1 of each 21-day treatment course administered intravenously. If required, the dose of Nintedanib could be reduced to 150 mg b.i.d. or 100 mg b.i.d. (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.","id":"FG003","title":"Nintedanib_Phase III"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"31"},{"groupId":"FG001","numSubjects":"32"},{"groupId":"FG002","numSubjects":"95"},{"groupId":"FG003","numSubjects":"92"}],"type":"PD based on modified RECIST criteria"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"5"},{"groupId":"FG002","numSubjects":"10"},{"groupId":"FG003","numSubjects":"13"}],"type":"Withdrawal by Subject"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"1"}],"type":"Protocol Violation"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"0"},{"groupId":"FG003","numSubjects":"1"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"1"},{"groupId":"FG003","numSubjects":"2"}],"type":"Not treated"},{"reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"10"},{"groupId":"FG003","numSubjects":"6"}],"type":"Other than reasons specified"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"3"},{"groupId":"FG002","numSubjects":"22"},{"groupId":"FG003","numSubjects":"23"}],"type":"Adverse event (AE)"},{"reasons":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"},{"groupId":"FG002","numSubjects":"8"},{"groupId":"FG003","numSubjects":"8"}],"type":"Worsening/AE underlying cancer disease"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"43"},{"groupId":"FG001","numSubjects":"44"},{"groupId":"FG002","numSubjects":"229"},{"groupId":"FG003","numSubjects":"229"}],"type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"41"},{"groupId":"FG001","numSubjects":"44"},{"groupId":"FG002","numSubjects":"228"},{"groupId":"FG003","numSubjects":"227"}],"type":"Treated Patients"},{"achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"4"},{"groupId":"FG002","numSubjects":"82"},{"groupId":"FG003","numSubjects":"83"}],"comment":"On treatment or completed according to protocol at the time of analysis","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"42"},{"groupId":"FG001","numSubjects":"40"},{"groupId":"FG002","numSubjects":"147"},{"groupId":"FG003","numSubjects":"146"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"All participants were screened for eligibility to participate in trial. Subjects attended specialist sites to ensure that they (the participants) met all implemented inclusion/exclusion criteria. Participants were not to be entered to trial if any of the specific entry criteria was violated.\n\nPD: Progressive Disease","recruitmentDetails":"Patients were initially treated with combination therapy consisting of nintedanib or placebo plus standard chemotherapy (pemetrexed/cisplatin), for a maximum of 6 cycles of 21 days duration. After completion of combination therapy, patients who had not progressed continued with nintedanib or placebo monotherapy."}