{"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"0"},{"groupId":"OG002","value":"0"}],"title":"irCR"},{"measurements":[{"groupId":"OG000","value":"3"},{"groupId":"OG001","value":"2"},{"groupId":"OG002","value":"2"}],"title":"irPR"},{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"11"},{"groupId":"OG002","value":"9"}],"title":"irSD"},{"measurements":[{"groupId":"OG000","value":"9"},{"groupId":"OG001","value":"8"},{"groupId":"OG002","value":"11"}],"title":"irPD"},{"measurements":[{"groupId":"OG000","value":"5"},{"groupId":"OG001","value":"5"},{"groupId":"OG002","value":"4"}],"title":"Missing/not available"}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"26"},{"groupId":"OG001","value":"26"},{"groupId":"OG002","value":"26"}],"units":"Participants"}],"description":"NSCLC only: Proportions with irCR, irPR, irSD, irPD, and NA are presented with 90% exact binomial confidence intervals.\n\nThe Immune-Related Response Criteria (irRC) is a set of published rules that defines when cancer tumors improve, stay the same, or worsen during treatment with an immuno-oncology drug. The response criteria are:\n\nirCR: Complete disappearance of all lesions, no new lesions, and confirmation by a repeat consecutive assessment no less than 4 weeks from date first documented; irPR: decrease in tumor burden \\>50% relative to baseline confirmed by repeat consecutive assessment at least 4 weeks later; irPD: increase in tumor burden \\>25% relative to nadir (minimum recorded tumor burden) confirmed by repeat consecutive assessment at least 4 weeks later; irSD: not meeting criteria for irCR or irPR in the absence of irPD.","groups":[{"description":"Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive high dose radiation therapy QD over 10 days for up to 3 fractions.\n\nDurvalumab: Given IV\n\nRadiation Therapy: Undergo radiation therapy\n\nTremelimumab: Given IV","id":"OG000","title":"Arm A (Tremelimumab, Durvalumab, HD-RT)"},{"description":"Patients receive tremelimumab and durvalumab as in Arm C. Beginning at week 2, patients receive low dose radiation therapy every 6 hours BID on weeks 2, 6, 10 and 14.\n\nDurvalumab: Given IV\n\nRadiation Therapy: Undergo radiation therapy\n\nTremelimumab: Given IV","id":"OG001","title":"Arm B (Tremelimumab, Durvalumab, LD-RT)"},{"description":"Patients receive tremelimumab IV and durvalumab IV over 60 minutes every 4 weeks for up to 16 weeks in the absence of disease progression or unacceptable toxicity. Patients then receive durvalumab IV over 60 minutes 4 weeks after last combination dose for up to 9 additional doses.\n\nDurvalumab: Given IV\n\nTremelimumab: Given IV","id":"OG002","title":"Arm C (Tremelimumab, Durvalumab)"}],"paramType":"COUNT_OF_PARTICIPANTS","populationDescription":"Patients receiving at least one regimen of protocol therapy.","reportingStatus":"POSTED","timeFrame":"Up to 2 years","title":"Objective Response Per Immune-related Response (irRC) Criteria","type":"SECONDARY","unitOfMeasure":"Participants"}