Durvalumab, Tremelimumab, and Platinum Chemotherapy in EGFR Mutation–Positive NSCLC: An Open-Label Phase 2 Trial (ILLUMINATE)
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Le résumé fourni par la source
Introduction EGFR -mutant NSCLC is associated with low mutation burden and low levels of PD-L1 expression. We conducted a phase 2 trial to determine the efficacy of durvalumab, tremelimumab, and platinum-pemetrexed in EGFR- mutant NSCLC after progression with EGFR tyrosine kinase inhibitors (TKIs). Methods Participants were treated with induction durvalumab, tremelimumab, and platinum-pemetrexed, followed by durvalumab-pemetrexed maintenance. Participants were divided into two cohorts: (1) EGFR exon 20 T790M negative (T790M−, progressing on either first-line osimertinib, or on a single line of first/second generation TKI), and (2) T790M positive (T790M+, progressing on greater than or equal to 1 lines of TKI, including osimertinib). The primary endpoint was the confirmed objective response rate (ORR) assessed by the investigators. Progression-free survival and safety were secondary outcomes. Results One hundred participants from Australia and Taiwan were enrolled. Median follow-up was 26 months with 88% and 96% experiencing progression events for T790M− and T790M+, respectively. The ORR for T790M− was 31% (95% confidence interval: 20–45), including two complete responses. The ORR for T790M+ was 21% (95% confidence interval: 12–34). Median durations of response were 9.5 months and 6.3 months for T790M− and T790M+, respectively; median progression-free survival rates were 6.5 months and 4.9 months, respectively. For T790M−, ORR was 27% for 50% or higher PD-L1 (n = 22) and 0% for less than 50% PD-L1 (n = 10), respectively. For T790M+, ORR was 17% for 50% or higher PD-L1 (n = 24). The safety profile was consistent with previous reports. Conclusions Durvalumab, tremelimumab, and platinum-pemetrexed had modest anti-tumor activity in EGFR- mutant NSCLC after progression on TKI. The T790M− cohort had higher ORR and a longer duration of response. Immune adverse events were not increased with tremelimumab. The clinical registration number of this trial is NCT03994393.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé ; titre concordant.
- Titre Crossref
- Durvalumab, Tremelimumab, and Platinum Chemotherapy in EGFR Mutation–Positive NSCLC: An Open-Label Phase 2 Trial (ILLUMINATE)
- Date Crossref
- 01/02/2025
- Éditeur
- Elsevier BV
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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The University of Sydney NHMRC Clinical Trials Centre pays non établi dans la noticeUniversité ou école supérieure
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National Health and Medical Research Council pays non établi dans la noticeOrganisme public
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National Taiwan University pays non établi dans la noticeUniversité ou école supérieure
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National Taiwan University Hospital pays non établi dans la noticeÉtablissement de santé
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Taipei Medical University Hospital pays non établi dans la noticeÉtablissement de santé
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Tri-Service General Hospital pays non établi dans la noticeÉtablissement de santé
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National Defense Medical Center pays non établi dans la noticeÉtablissement de santé
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The University of Queensland pays non établi dans la noticeUniversité ou école supérieure
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Prince Charles Hospital pays non établi dans la noticeÉtablissement de santé
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Taichung Veterans General Hospital pays non établi dans la noticeÉtablissement de santé
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Queensland University of Technology pays non établi dans la noticeUniversité ou école supérieure
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Taipei Veterans General Hospital pays non établi dans la noticeÉtablissement de santé
NHMRC Clinical Trials Centre — The University of Sydney, National Health and Medical Research Council et National Taiwan University, avec 9 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.