{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,29]],"date-time":"2026-07-29T23:00:25Z","timestamp":1785366025043,"version":"3.55.0"},"reference-count":16,"publisher":"Wiley","issue":"21","license":[{"start":{"date-parts":[[2025,10,23]],"date-time":"2025-10-23T00:00:00Z","timestamp":1761177600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100004334","name":"Merck","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004334","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["acsjournals.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer"],"published-print":{"date-parts":[[2025,11]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Treatment options for patients with advanced non\u2013small cell lung cancer (NSCLC) with disease progression following immune checkpoint inhibitor (ICI) and platinum\u2010based chemotherapy are limited. GT103 is a fully human immunoglobulin G3 monoclonal antibody targeting complement factor H, which promotes antitumor immunity. In a Phase I study, GT103 was well tolerated and maximum tolerated dose was not reached.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A single arm, Simon two\u2010stage, Phase II study was conducted that evaluated efficacy and safety of GT103 plus pembrolizumab in patients with advanced NSCLC who have had progression on up to two lines of therapy, including an ICI. Patients with actionable genomic drivers were eligible if they had received at least one targeted therapy. Patients received GT103 10 mg\/kg and pembrolizumab 200 mg intravenously every 3 weeks until disease progression or unacceptable toxicity. Primary objectives were safety and objective response rate. Secondary objectives were overall survival and progression\u2010free survival.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Twenty\u2010one patients were enrolled. Most common treatment\u2010related adverse events occurring in \u226510% of patients were fatigue (24%,\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a05) and decreased lymphocyte count (24%,\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a05). One patient experienced grade 3 treatment\u2010related adverse events, including pneumonitis and decreased lymphocyte count. Objective response rate was 10% (95% CI, 1\u201330) with two objective responses (1 complete response (CR), 1 partial response (PR)). Disease control rate (=\u00a0CR\u00a0+\u00a0PR\u00a0+\u00a0stable disease (SD)) was 67% (\n                      <jats:italic>n<\/jats:italic>\n                      \u00a0=\u00a014). Four patients (19%) experienced disease control for over 9 months. Median progression\u2010free survival was 2.6 months (95% CI, 1.4\u20134.0) and median overall survival was 10.3 months (95% CI, 6.6\u2013NE).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Combination of GT103 with pembrolizumab was well tolerated with no new safety signals. A subset of patients experienced durable responses and disease control despite prior exposure to ICI.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/cncr.70141","type":"journal-article","created":{"date-parts":[[2025,10,23]],"date-time":"2025-10-23T15:04:18Z","timestamp":1761231858000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["A Phase II study of GT103 in combination with pembrolizumab in refractory, metastatic non\u2013small cell lung cancer"],"prefix":"10.1002","volume":"131","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3874-8703","authenticated-orcid":false,"given":"Hirva","family":"Mamdani","sequence":"first","affiliation":[{"name":"Department of Oncology Barbara Ann Karmanos Cancer Institute Wayne State University School of Medicine  Detroit Michigan USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryan D.","family":"Gentzler","sequence":"additional","affiliation":[{"name":"Division of Hematology\/Oncology Department of Medicine University of Virginia Cancer Center  Charlottesville Virginia USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lin","family":"Gu","sequence":"additional","affiliation":[{"name":"Duke Cancer Institute Duke Health  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alberto A.","family":"Chiappori","sequence":"additional","affiliation":[{"name":"H. Lee Moffitt Cancer Center  Tampa Florida USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank D.","family":"Weinberg","sequence":"additional","affiliation":[{"name":"University of Illinois Chicago  Chicago Illinois USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2606-745X","authenticated-orcid":false,"given":"Greg","family":"Durm","sequence":"additional","affiliation":[{"name":"Indiana University Health  Indianapolis Indiana USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sarada","family":"Gurubhagavatula","sequence":"additional","affiliation":[{"name":"Summit Health  Livingston New Jersey USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3595-8011","authenticated-orcid":false,"given":"Thomas E.","family":"Stinchcombe","sequence":"additional","affiliation":[{"name":"Duke Cancer Institute Duke Health  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"II","given":"James E.","family":"Herndon","sequence":"additional","affiliation":[{"name":"Duke Cancer Institute Duke Health  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr","given":"Edward F.","family":"Patz","sequence":"additional","affiliation":[{"name":"Grid Therapeutics  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeffrey","family":"Clarke","sequence":"additional","affiliation":[{"name":"Duke Cancer Institute Duke Health  Durham North Carolina USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,10,23]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21820"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.molimm.2010.05.007"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.3892\/ijo.2011.1010"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.4049\/jimmunol.164.11.6075"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1080\/2162402X.2020.1731135"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.celrep.2016.04.038"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1158\/1535\u20107163.MCT\u201022\u20100723"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.4049\/jimmunol.2300728"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/jev2.12031"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41467\u2010024\u201055092\u20102"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.3389\/fcell.2024.1302490"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ctrv.2023.102545"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.22.00912"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eclinm.2023.102156"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0252577"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12943\u2010021\u201001490\u20109"}],"container-title":["Cancer"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/acsjournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cncr.70141","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,11,3]],"date-time":"2025-11-03T20:27:27Z","timestamp":1762201647000},"score":1,"resource":{"primary":{"URL":"https:\/\/acsjournals.onlinelibrary.wiley.com\/doi\/10.1002\/cncr.70141"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,10,23]]},"references-count":16,"journal-issue":{"issue":"21","published-print":{"date-parts":[[2025,11]]}},"alternative-id":["10.1002\/cncr.70141"],"URL":"https:\/\/doi.org\/10.1002\/cncr.70141","archive":["Portico"],"relation":{},"ISSN":["0008-543X","1097-0142"],"issn-type":[{"value":"0008-543X","type":"print"},{"value":"1097-0142","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,10,23]]},"assertion":[{"value":"2025-06-09","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-09-08","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2025-10-23","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e70141"}}