2021
Trial in progress: A phase 1b study of sotorasib, a specific and irreversible KRASG12C inhibitor, as monotherapy in non-small cell lung cancer (NSCLC) with brain metastasis and in combination with other anticancer therapies in advanced solid tumors (CodeBreaK 101).
Hong D, Strickler J, Fakih M, Falchook G, Li B, Durm G, Burns T, Ramalingam S, Goldberg S, Frank R, Marrone K, Shu C, Gandara D, Soman N, Henary H, Govindan R. Trial in progress: A phase 1b study of sotorasib, a specific and irreversible KRASG12C inhibitor, as monotherapy in non-small cell lung cancer (NSCLC) with brain metastasis and in combination with other anticancer therapies in advanced solid tumors (CodeBreaK 101). Journal Of Clinical Oncology 2021, 39: tps2669-tps2669. DOI: 10.1200/jco.2021.39.15_suppl.tps2669.Peer-Reviewed Original ResearchNon-small cell lung cancerCombination regimensSolid tumorsG12C mutationKRAS p.Treatment-related adverse eventsAntitumor efficacyPhase 1b studyPrior systemic therapyOpen-label studyAdvanced solid tumorsDurable clinical benefitDose-limiting toxicityKey eligibility criteriaMetastatic solid tumorsAnticancer therapyCell lung cancerOncogenic driver mutationsCombination cohortManageable toxicityDose expansionPrimary endpointSecondary endpointsTolerability profileAdverse events
2015
Phase III, randomized, open-label study of durvalumab (MEDI4736) in combination with tremelimumab or durvalumab alone versus platinum-based chemotherapy in first-line treatment of patients with advanced/metastatic NSCLC: MYSTIC
Rizvi N, Barlesi F, Brahmer J, Felip E, Forde P, Garassino M, Goldberg S, Vansteenkiste J, Jarkowski A, McIntosh S, Zhao L, Antonia S. Phase III, randomized, open-label study of durvalumab (MEDI4736) in combination with tremelimumab or durvalumab alone versus platinum-based chemotherapy in first-line treatment of patients with advanced/metastatic NSCLC: MYSTIC. Journal For ImmunoTherapy Of Cancer 2015, 3: p171. PMCID: PMC4646121, DOI: 10.1186/2051-1426-3-s2-p171.Peer-Reviewed Original Research
2014
A phase 1b open-label study to evaluate the safety and tolerability of MEDI4736, an anti–PD-L1 antibody, in combination with tremelimumab in subjects with advanced non–small cell lung cancer.
Pinder M, Rizvi N, Goldberg S, Balmanoukian A, Narwal R, Robbins P, D'Angelo G, Blake-Haskins A, Karakunnel J, Antonia S. A phase 1b open-label study to evaluate the safety and tolerability of MEDI4736, an anti–PD-L1 antibody, in combination with tremelimumab in subjects with advanced non–small cell lung cancer. Journal Of Clinical Oncology 2014, 32: e19137-e19137. DOI: 10.1200/jco.2014.32.15_suppl.e19137.Peer-Reviewed Original Research