{"groups":[{"description":"During chemotherapy (combination) stage:\n\nPatients received tremelimumab 75 milligrams (mg) + durvalumab 1500 mg combination therapy + SoC chemotherapy via intravenous (IV) infusion every 3 weeks (Q3W) for 4 doses/cycles (Weeks 0, 3, 6 and 9).\n\nThe SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).\n\nPost-chemotherapy (maintenance) stage:\n\nPatients then continued to receive durvalumab monotherapy 1500 mg IV infusion every 4 weeks (Q4W) from Week 12 until progressive disease (PD), unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met. Patients also received an additional dose of tremelimumab 75 mg (in combination with durvalumab) at Week 16 post-chemotherapy.\n\nNon-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator.","id":"FG000","title":"T + D + SoC"},{"description":"During chemotherapy (combination) stage:\n\nPatients received durvalumab 1500 mg monotherapy + SoC chemotherapy via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9).\n\nThe SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).\n\nPost-chemotherapy (maintenance) stage:\n\nPatients then continued to receive durvalumab monotherapy 1500 mg IV infusion Q4W from Week 12 until PD, unless there was unacceptable toxicity, withdrawal of consent, or another discontinuation criterion was met.\n\nNon-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q4W from Week 12 until PD, unless contraindicated per the Investigator.","id":"FG001","title":"D + SoC"},{"description":"During chemotherapy (combination) stage:\n\nPatients received SoC chemotherapy alone via IV infusion Q3W for 4 doses/cycles (Weeks 0, 3, 6 and 9). Patients could also receive SoC chemotherapy for an additional 2 cycles Q3W on Weeks 12 and 15 if clinically indicated and at the Investigator's discretion before the patient entered follow-up.\n\nThe SoC chemotherapy was the Investigator's choice of one of the following regimens: abraxane + carboplatin (squamous and non-squamous patients), pemetrexed + cisplatin or carboplatin (non-squamous patients only), or gemcitabine + cisplatin or carboplatin (squamous patients only).\n\nPost-chemotherapy (maintenance) stage:\n\nNon-squamous patients who received pemetrexed + carboplatin/cisplatin during chemotherapy stage could receive pemetrexed maintenance therapy, given Q3W or Q4W (dependent on Investigator decision and local standards) from Week 12 until PD, unless contraindicated per the Investigator.","id":"FG002","title":"SoC Alone"}],"periods":[{"dropWithdraws":[{"reasons":[{"groupId":"FG000","numSubjects":"250"},{"groupId":"FG001","numSubjects":"264"},{"groupId":"FG002","numSubjects":"279"}],"type":"Death"},{"reasons":[{"groupId":"FG000","numSubjects":"2"},{"groupId":"FG001","numSubjects":"2"},{"groupId":"FG002","numSubjects":"2"}],"type":"Lost to Follow-up"},{"reasons":[{"groupId":"FG000","numSubjects":"6"},{"groupId":"FG001","numSubjects":"7"},{"groupId":"FG002","numSubjects":"16"}],"type":"Withdrawal by Subject"}],"milestones":[{"achievements":[{"groupId":"FG000","numSubjects":"338"},{"groupId":"FG001","numSubjects":"338"},{"groupId":"FG002","numSubjects":"337"}],"comment":"Randomized and included in global cohort analysis","type":"STARTED"},{"achievements":[{"groupId":"FG000","numSubjects":"331"},{"groupId":"FG001","numSubjects":"335"},{"groupId":"FG002","numSubjects":"331"}],"type":"Received Treatment"},{"achievements":[{"groupId":"FG000","numSubjects":"80"},{"groupId":"FG001","numSubjects":"65"},{"groupId":"FG002","numSubjects":"40"}],"comment":"Completed study or ongoing in study at primary completion date (global cohort final analysis DCO of 12 March 2021)","type":"COMPLETED"},{"achievements":[{"groupId":"FG000","numSubjects":"258"},{"groupId":"FG001","numSubjects":"273"},{"groupId":"FG002","numSubjects":"297"}],"type":"NOT COMPLETED"}],"title":"Overall Study"}],"preAssignmentDetails":"Patients were randomized in a stratified manner as per programmed cell death ligand 1 (PD-L1) tumor expression status (PD-L1 tumor cells \\[TC\\] ≥50% versus \\[vs\\] \\<50%), disease stage (IVA vs IVB), and histology (non-squamous vs squamous) in a 1:1:1 ratio to receive treatment with tremelimumab + durvalumab combination therapy + standard of care (SoC) chemotherapy (also referred to as T+ D + SoC), durvalumab monotherapy + SoC chemotherapy (also referred to as D + SoC), or SoC chemotherapy alone.","recruitmentDetails":"Study was conducted in 142 study centers across 18 countries in North and Latin America, Europe, Asia Pacific and Africa. First patient randomized: 27 June 2017. Results are presented for the global cohort at final analysis data cut-offs (DCOs) of 24 July 2019 (Response Evaluation Criteria in Solid Tumors \\[RECIST\\]-based endpoints) and 12 March 2021 (all other data). Once global enrollment was complete, enrollment was started in mainland China. Results for the China cohort will be reported later."}