{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Zhou C"],"funding":["NCI NIH HHS"],"pagination":["e214761"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC8517885"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["7(12)"],"pubmed_abstract":["<h4>Importance</h4>Metastatic non-small cell lung cancer (mNSCLC) with EGFR exon 20 insertion (EGFRex20ins) mutations is associated with a poor prognosis. Mobocertinib is an oral tyrosine kinase inhibitor designed to selectively target EGFRex20ins mutations.<h4>Objective</h4>To evaluate treatment outcomes and safety of mobocertinib in patients with previously treated EGFRex20ins-positive mNSCLC.<h4>Design, setting, and participants</h4>This 3-part, open-label, phase 1/2 nonrandomized clinical trial with dose-escalation/dose-expansion cohorts (28 sites in the US) and a single-arm extension cohort (EXCLAIM; 40 sites in Asia, Europe, and North America) was conducted between June 2016 and November 2020 (data cutoff date). The primary analysis populations were the platinum-pretreated patients ("],"journal":["JAMA oncology"],"pubmed_title":["Treatment Outcomes and Safety of Mobocertinib in Platinum-Pretreated Patients With EGFR Exon 20 Insertion-Positive Metastatic Non-Small Cell Lung Cancer: A Phase 1/2 Open-label Nonrandomized Clinical Trial."],"pmcid":["PMC8517885"],"funding_grant_id":["P30 CA008748"],"pubmed_authors":["Kim SW","Mehta M","Mekhail T","Garcia Campelo MR","Jin S","Janne PA","Felip E","Griffin C","Bunn V","Vincent S","Ramalingam SS","Zhou C","Yang JC","Nguyen D","Riely GJ","Lin J","Lin HM","Kim TM"],"additional_accession":[]},"is_claimable":false,"name":"Treatment Outcomes and Safety of Mobocertinib in Platinum-Pretreated Patients With EGFR Exon 20 Insertion-Positive Metastatic Non-Small Cell Lung Cancer: A Phase 1/2 Open-label Nonrandomized Clinical Trial.","description":"<h4>Importance</h4>Metastatic non-small cell lung cancer (mNSCLC) with EGFR exon 20 insertion (EGFRex20ins) mutations is associated with a poor prognosis. Mobocertinib is an oral tyrosine kinase inhibitor designed to selectively target EGFRex20ins mutations.<h4>Objective</h4>To evaluate treatment outcomes and safety of mobocertinib in patients with previously treated EGFRex20ins-positive mNSCLC.<h4>Design, setting, and participants</h4>This 3-part, open-label, phase 1/2 nonrandomized clinical trial with dose-escalation/dose-expansion cohorts (28 sites in the US) and a single-arm extension cohort (EXCLAIM; 40 sites in Asia, Europe, and North America) was conducted between June 2016 and November 2020 (data cutoff date). The primary analysis populations were the platinum-pretreated patients (","dates":{"release":"2021-01-01T00:00:00Z","publication":"2021 Dec","modification":"2026-05-08T08:08:10.239Z","creation":"2022-02-11T14:22:12.18Z"},"accession":"S-EPMC8517885","cross_references":{"pubmed":["34647988"],"doi":["10.1001/jamaoncol.2021.4761"]}}