{"entity":{"id":"nct02453282","kind":"trial","name":"Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC)","aka":["MYSTIC"],"tldr":"A phase 3 trial of Durvalumab, Tremelimumab, Carboplatin, Gemcitabine + cisplatin, Gemcitabine and Cisplatin in non-small-cell lung cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Phase III Open Label First Line Therapy Study of MEDI 4736 (Durvalumab) With or Without Tremelimumab Versus SOC in Non Small-Cell Lung Cancer (NSCLC) is a phase 3 interventional study registered as NCT02453282 by AstraZeneca, with 1118 participants enrolled, started 2015-07-21 and due to reach its primary completion in 2018-10-04. Interventions recorded: MEDI4736 (Durvalumab), MEDI4736 (Durvalumab)+Tremelimumab, Paclitaxel + Carboplatin, Gemcitabine + Cisplatin, Gemcitabine + Carboplatin and Pemetrexed + Cisplatin. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT02453282","url":"https://clinicaltrials.gov/study/NCT02453282"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["nsclc"],"sections":[],"technologies":["checkpoint-inhibitor"],"targets":[],"drugs":["durvalumab","tremelimumab","carboplatin","gemcitabine-cisplatin","gemcitabine","cisplatin"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct02453282-jama-oncol-2020"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02453282","phase":"3","setting":"A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination With Tremelimumab Therapy or MEDI4736 Monotherapy Versus Standard of Care Platinum-Based Chemotherapy in First Line Treatment of Patients With Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC)(MYSTIC).","sponsor":"AstraZeneca","started":"2015-07-21","startedType":"actual","yearReported":2019,"enrolled":1118,"enrolledBasis":"registry","outcomes":[{"endpoint":"Overall Survival (OS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab Monotherapy Vs SoC Chemotherapy and Durvalumab + Tremelimumab Vs SoC Chemotherapy","primary":true,"unit":"months","arms":[{"name":"Durvalumab Monotherapy","n":163,"value":16.3,"note":"95% CI 12.2 to 20.8; Figures from the ClinicalTrials.gov results section (first posted 2019-11-29), not from a publication"},{"name":"Durvalumab + Tremelimumab","n":163,"value":11.9,"note":"95% CI 9.0 to 17.7"},{"name":"SoC Chemotherapy","n":162,"value":12.9,"note":"95% CI 10.5 to 15.0"}],"source":"https://clinicaltrials.gov/study/NCT02453282?tab=results"},{"endpoint":"Progression-Free Survival (PFS); PD-L1 (TC >=25%) Analysis Set Population, Durvalumab + Tremelimumab Vs SoC Chemotherapy","primary":true,"unit":"months","arms":[{"name":"Durvalumab + Tremelimumab","n":163,"value":3.9,"note":"95% CI 2.8 to 5.0; Figures from the ClinicalTrials.gov results section (first posted 2019-11-29), not from a publication"},{"name":"SoC Chemotherapy","n":162,"value":5.4,"note":"95% CI 4.6 to 5.8"}],"hr":1.05,"p":"0.705","source":"https://clinicaltrials.gov/study/NCT02453282?tab=results"},{"endpoint":"Objective Response Rate (ORR); PD-L1 (TC >=25%) Analysis Set Population","unit":"%","arms":[{"name":"Durvalumab Monotherapy","n":163,"value":35.6,"note":"Figures from the ClinicalTrials.gov results section (first posted 2019-11-29), not from a publication"},{"name":"Durvalumab + Tremelimumab","n":163,"value":34.4},{"name":"SoC Chemotherapy","n":162,"value":37.7}],"source":"https://clinicaltrials.gov/study/NCT02453282?tab=results"}]},"route":"/trials/nct02453282/","neighbours":{"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"technology":[{"id":"checkpoint-inhibitor","kind":"technology","name":"Immune checkpoint inhibitors","route":"/technologies/checkpoint-inhibitor/"}],"drug":[{"id":"carboplatin","kind":"drug","name":"Carboplatin","route":"/drugs/carboplatin/"},{"id":"cisplatin","kind":"drug","name":"Cisplatin","route":"/drugs/cisplatin/"},{"id":"durvalumab","kind":"drug","name":"Durvalumab","route":"/drugs/durvalumab/"},{"id":"gemcitabine","kind":"drug","name":"Gemcitabine","route":"/drugs/gemcitabine/"},{"id":"gemcitabine-cisplatin","kind":"drug","name":"Gemcitabine + cisplatin","route":"/drugs/gemcitabine-cisplatin/"},{"id":"tremelimumab","kind":"drug","name":"Tremelimumab","route":"/drugs/tremelimumab/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}],"paper":[{"id":"paper-nct02453282-jama-oncol-2020","kind":"paper","name":"Durvalumab With or Without Tremelimumab vs Standard Chemotherapy in First-line Treatment of Metastatic Non-Small Cell Lung Cancer: The MYSTIC Phase 3 Randomized Clinical Trial","route":"/key-papers/paper-nct02453282-jama-oncol-2020/"}],"term":[{"id":"lung-failed-programmes","kind":"term","name":"Lung cancer: the failed and stopped programmes, and why","route":"/terms/lung-failed-programmes/"}],"trial":[{"id":"nct03164616","kind":"trial","name":"Study of Durvalumab + Tremelimumab With Chemotherapy or Durvalumab With Chemotherapy or Chemotherapy Alone for Patients With Lung Cancer (POSEIDON).","route":"/trials/nct03164616/"}]}}