The DOI matches its Crossref record; 34 of the 34 references it cites were found in a registry or an index.
Osimertinib after Chemoradiotherapy in Stage III EGFR -Mutated NSCLC
Abstract
Background Osimertinib is a recommended treatment for advanced non–small-cell lung cancer (NSCLC) with an epidermal growth factor receptor ( EGFR ) mutation and as adjuvant treatment for resected EGFR -mutated NSCLC. EGFR-tyrosine kinase inhibitors have shown preliminary efficacy in unresectable stage III EGFR -mutated NSCLC. Methods In this phase 3, double-blind, placebo-controlled trial, we randomly assigned patients with unresectable EGFR -mutated stage III NSCLC without progression during or after chemoradiotherapy to receive osimertinib or placebo until disease progression occurred (as assessed by blinded independent central review) or the regimen was discontinued. The primary end point was progression-free survival as assessed by blinded independent central review. Results A total of 216 patients who had undergone chemoradiotherapy were randomly assigned to receive osimertinib (143 patients) or placebo (73 patients). Osimertinib resulted in a significant progression-free survival benefit as compared with placebo: the median progression-free survival was 39.1 months with osimertinib versus 5.6 months with placebo, with a hazard ratio for disease progression or death of 0.16 (95% confidence interval [CI], 0.10 to 0.24; P<0.001). The percentage of patients who were alive and progression free at 12 months was 74% (95% CI, 65 to 80) with osimertinib and 22% (95% CI, 13 to 32) with placebo. Interim overall survival data (maturity, 20%) showed 36-month overall survival among 84% of patients with osimertinib (95% CI, 75 to 89) and 74% with placebo (95% CI, 57 to 85), with a hazard ratio for death of 0.81 (95% CI, 0.42 to 1.56; P=0.53). The incidence of adverse events of grade 3 or higher was 35% in the osimertinib group and 12% in the placebo group; radiation pneumonitis (majority grade, 1 to 2) was reported in 48% and 38%, respectively. No new safety concerns emerged. Conclusions Treatment with osimertinib resulted in significantly longer progression-free survival than placebo in patients with unresectable stage III EGFR -mutated NSCLC. (Funded by AstraZeneca; LAURA ClinicalTrials.gov number, NCT03521154 .)
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Osimertinib in Untreated EGFR -Mutated Advanced Non–Small-Cell Lung Cancer
Soria, J.-C., Ohe, Y., Vansteenkiste, J., Reungwetwattana, T., Chewaskulyong, B., Lee, K. H., Dechaphunkul, A., Imamura, F., Nogami, N., Kurata, T., et al. (2018) · New England Journal of Medicine · doi:10.1056/nejmoa1713137 · Cited by 5,508
Self-citationDurvalumab after chemoradiotherapy in stage III non–small-cell lung cancer
Antonia, S. J., Villegas, A., Daniel, D., Vicente, D., Murakami, S., Hui, R., Yokoi, T., Chiappori, A., Lee, K. H., de Wit, M., et al. (2017) · New England Journal of Medicine · doi:10.1056/nejmoa1709937 · Cited by 4,593
Self-citationOsimertinib or Platinum–Pemetrexed in EGFR T790M–Positive Lung Cancer
Mok, T. S., Wu, Y.-L., Ahn, M.-J., Garassino, M. C., Kim, H. R., Ramalingam, S. S., Shepherd, F. A., He, Y., Akamatsu, H., Theelen, W. S. M. E., et al. (2017) · New England Journal of Medicine · doi:10.1056/nejmoa1612674 · Cited by 3,379
Self-citationCross, D. A. E., Ashton, S. E., Ghiorghiu, S., Eberlein, C., Nebhan, C. A., Spitzler, P. J., Orme, J. P., Finlay, M. R. V., Ward, R. A., Mellor, M. J., et al. (2014) · Cancer Discovery · doi:10.1158/2159-8290.cd-14-0337 · Cited by 2,246
Aupérin, A., Le Péchoux, C., Rolland, E., Curran, W. J., Furuse, K., Fournel, P., Belderbos, J., Clamon, G., Ulutin, H. C., Paulus, R., et al. (2010) · Journal of Clinical Oncology · doi:10.1200/jco.2009.26.2543 · Cited by 1,878
Osimertinib in Resected EGFR -Mutated Non–Small-Cell Lung Cancer
Wu, Y.-L., Tsuboi, M., He, J., John, T., Grohe, C., Majem, M., Goldman, J. W., Laktionov, K., Kim, S.-W., Kato, T., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa2027071 · Cited by 1,798
Self-citationHendriks, L. E., Kerr, K. M., Menis, J., Mok, T. S., Nestle, U., Passaro, A., Peters, S., Planchard, D., Smit, E. F., Solomon, B. J., et al. (2023) · Annals of Oncology · doi:10.1016/j.annonc.2022.12.009 · Cited by 853
Reungwetwattana, T., Nakagawa, K., Cho, B. C., Cobo, M., Cho, E. K., Bertolini, A., Bohnet, S., Zhou, C., Lee, K. H., Nogami, N., et al. (2018) · Journal of Clinical Oncology · doi:10.1200/jco.2018.78.3118 · Cited by 811
Self-citationWalters, S., Maringe, C., Coleman, M. P., Peake, M. D., Butler, J., Young, N., Bergström, S., Hanna, L., Jakobsen, E., Kölbeck, K., et al. (2013) · Thorax · doi:10.1136/thoraxjnl-2012-202297 · Cited by 575
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Cited by
Advances in molecular pathology and therapy of non-small cell lung cancer
Huang, Q., Li, Y., Huang, Y., Wu, J., Bao, W., Xue, C., Li, X., Dong, S., Dong, Z., & Hu, S. (2025) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-025-02243-6 · Cited by 197
Targeted Therapies in Non–Small Cell Lung Cancer: A Contemporary Review
Abdelmonem, A., Bikram Shah, B., Shebli, M. A., & Tabbara, I. A. (2026) · American Journal of Clinical Oncology · doi:10.1097/coc.0000000000001275 · Cited by 4
Metadata
- Authors
- Lu, S., Kato, T., Dong, X., Ahn, M.-J., Quang, L.-V., Soparattanapaisarn, N., Inoue, T., Wang, C.-L., Huang, M., Yang, J. C.-H., Cobo, M., Özgüroğlu, M., Casarini, I., Khiem, D.-V., Sriuranpong, V., Cronemberger, E., Takahashi, T., Runglodvatana, Y., Chen, M., Huang, X., Grainger, E., Ghiorghiu, D., van der Gronde, T., & Ramalingam, S. S.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2024-08-15
- Volume
- 391
- Issue
- 7
- Pages
- 585-597
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W4399274593
- Cited by
- 346
- References
- 34
- FWCI
- 88.28
- Type
- journal article
- Language
- en
- Open access
- closed
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- Lu, S., Kato, T., Dong, X., Ahn, M.-J., Quang, L.-V., Soparattanapaisarn, N., Inoue, T., Wang, C.-L., Huang, M., Yang, J. C.-H., Cobo, M., Özgüroğlu, M., Casarini, I., Khiem, D.-V., Sriuranpong, V., Cronemberger, E., Takahashi, T., Runglodvatana, Y., Chen, M., . . . Ramalingam, S. S. (2024). Osimertinib after Chemoradiotherapy in Stage III EGFR -Mutated NSCLC. New England Journal of Medicine. https://doi.org/10.1056/nejmoa2402614
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