{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,19]],"date-time":"2026-10-19T09:48:56Z","timestamp":1792403336467,"version":"4.4.0"},"reference-count":44,"publisher":"BMJ","issue":"6","license":[{"start":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T00:00:00Z","timestamp":1782086400000},"content-version":"unspecified","delay-in-days":21,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100002491","name":"Bristol-Myers Squibb","doi-asserted-by":"publisher","award":["CA209-7T4"],"award-info":[{"award-number":["CA209-7T4"]}],"id":[{"id":"10.13039\/100002491","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["J Immunother Cancer"],"accepted":{"date-parts":[[2026,6,3]]},"published-print":{"date-parts":[[2026,6]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Response to anti-programmed cell death protein-1 (anti-PD-1) immunotherapy remains limited in patients with metastatic non-small cell lung cancer (NSCLC), whose tumors exhibit low or absent programmed death-ligand 1 (PD-L1) expression, and subsequent second-line therapy has poor efficacy. To address this limitation, we evaluated the efficacy and safety of combined ipilimumab and nivolumab (IPI\/NIVO) with subablative radiotherapy (RT) in patients with metastatic NSCLC with negative or low PD-L1 expression, who had progressed on prior anti-PD-1 therapy.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This single-arm, prospective phase II trial aimed to enroll 30 evaluable patients with metastatic NSCLC exhibiting low (1\u201349%)\u2009or negative (&lt;1%) PD-L1 tumor expression who had progressed after first-line anti-PD-1 therapy. Primary endpoints were safety, disease control rate (DCR), and objective response rate (ORR) at 6 and 12 weeks, assessed in non-irradiated tumor lesions. Treatment consisted of IPI 1\u2009mg\/kg every 6 weeks (Q6W) and NIVO 240\u2009mg every 2 weeks for 6 weeks combined with subablative RT (3\u00d78\u2009Gy to 1\u20134 lesions). Thereafter, IPI 1\u2009mg\/kg Q6W and NIVO 360\u2009mg every 3 weeks were continued.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In 31 patients of the intention-to-treat population, ORR was 7% and 10% at 6 and 12 weeks, and reached 29% as the best response. DCR was 58% and 39% at 6 and 12 weeks. Overall survival (OS) differed significantly by best response, with a median OS of 3.1, 13.5 and 22.5 months for progressive disease, stable disease and partial\/complete response (p&lt;0.001). Baseline sum of longest diameters, together with age, blood inflammatory markers and albumin levels, were prognostic of treatment response. All patients experienced treatment-related adverse events (AEs), with grade 3 as the highest severity in eight patients (26%). Immune-related AEs led to treatment discontinuation in five patients (16%). Early T-cell activation in peripheral blood samples (day 8) was detectable and more pronounced in responders than in progressors.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>In patients with metastatic NSCLC and low or negative tumor PD-L1 expression, IPI\/NIVO\/RT was able to induce objective clinical responses in a subset of patients who had progressed after first-line anti-PD1 therapy. Treatment was associated with a strong T-cell activation, improved OS and an acceptable safety profile.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>2020\u2013001097-29.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/jitc-2025-014724","type":"journal-article","created":{"date-parts":[[2026,6,22]],"date-time":"2026-06-22T14:55:59Z","timestamp":1782140159000},"page":"e014724","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":1,"title":["Rescue by radiotherapy and anti-CTLA4\/PD-1 after failure of anti-PD-1 therapy in patients with metastatic NSCLC: the phase II RECLAIM trial"],"prefix":"10.1136","volume":"14","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1551-738X","authenticated-orcid":false,"given":"Ezgi B","family":"Ulas","sequence":"first","affiliation":[{"name":"Department of Pulmonary Medicine, Amsterdam UMC Location VUmc, Amsterdam, The Netherlands"},{"name":"Cancer Center Amsterdam, Amsterdam, The Netherlands"},{"name":"Amsterdam Institute for Immunology and Infectious Diseases, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nora D","family":"Purcell","sequence":"additional","affiliation":[{"name":"Cancer Center Amsterdam, Amsterdam, The Netherlands"},{"name":"Amsterdam Institute for Immunology and Infectious Diseases, Amsterdam, The Netherlands"},{"name":"Department of Radiation Oncology, Amsterdam UMC Location VUmc, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ilias","family":"Houda","sequence":"additional","affiliation":[{"name":"Department of Pulmonary Medicine, Amsterdam UMC Location VUmc, Amsterdam, The Netherlands"},{"name":"Cancer Center Amsterdam, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sayed M S","family":"Hashemi","sequence":"additional","affiliation":[{"name":"Department of Pulmonary Medicine, Amsterdam UMC Location VUmc, Amsterdam, The Netherlands"},{"name":"Cancer Center Amsterdam, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joris","family":"Veltman","sequence":"additional","affiliation":[{"name":"Department of Pulmonary Medicine, Amsterdam UMC Location VUmc, Amsterdam, The Netherlands"},{"name":"Cancer Center Amsterdam, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johannes M A","family":"Daniels","sequence":"additional","affiliation":[{"name":"Department of Pulmonary Medicine, Amsterdam UMC Location VUmc, Amsterdam, The Netherlands"},{"name":"Cancer Center Amsterdam, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3036-8618","authenticated-orcid":false,"given":"Marieke F","family":"Fransen","sequence":"additional","affiliation":[{"name":"Department of Pulmonary Medicine, Amsterdam UMC Location VUmc, Amsterdam, The Netherlands"},{"name":"Cancer Center Amsterdam, Amsterdam, The Netherlands"},{"name":"Amsterdam Institute for Immunology and Infectious Diseases, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teodora","family":"Radonic","sequence":"additional","affiliation":[{"name":"Cancer Center Amsterdam, Amsterdam, The Netherlands"},{"name":"Amsterdam Institute for Immunology and Infectious Diseases, Amsterdam, The Netherlands"},{"name":"Department of Pathology, Amsterdam UMC Location VUmc, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linda R","family":"Beeloo","sequence":"additional","affiliation":[{"name":"Cancer Center Amsterdam, Amsterdam, The Netherlands"},{"name":"Department of Radiation Oncology, Amsterdam UMC Location VUmc, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter S N","family":"van Rossum","sequence":"additional","affiliation":[{"name":"Cancer Center Amsterdam, Amsterdam, The Netherlands"},{"name":"Department of Radiation Oncology, Amsterdam UMC Location VUmc, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2544-544X","authenticated-orcid":false,"given":"Febe","family":"van Maldegem","sequence":"additional","affiliation":[{"name":"Cancer Center Amsterdam, Amsterdam, The Netherlands"},{"name":"Amsterdam Institute for Immunology and Infectious Diseases, Amsterdam, The Netherlands"},{"name":"Department of Molecular Cell Biology and Immunology, Amsterdam UMC Location VUmc, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicole","family":"Barlo","sequence":"additional","affiliation":[{"name":"Department of Pulmonary Medicine, Noordwest 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