biostudies-literatureZhou CNCI NIH HHSe214761https://www.ebi.ac.uk/biostudies/studies/S-EPMC8517885biostudies-literatureUnknown7(12)<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 (JAMA oncologyTreatment 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.PMC8517885P30 CA008748Kim SWMehta MMekhail TGarcia Campelo MRJin SJanne PAFelip EGriffin CBunn VVincent SRamalingam SSZhou CYang JCNguyen DRiely GJLin JLin HMKim TMfalseTreatment 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.<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 (2021-01-01T00:00:00Z2021 Dec2026-05-08T08:08:10.239Z2022-02-11T14:22:12.18ZS-EPMC85178853464798810.1001/jamaoncol.2021.4761