The DOI matches its Crossref record; 21 of the 21 references it cites were found in a registry or an index.
Trastuzumab Deruxtecan in Patients With HER2-Mutant Metastatic Non–Small-Cell Lung Cancer: Primary Results From the Randomized, Phase II DESTINY-Lung02 Trial
Open accessAbstract
PURPOSE: Trastuzumab deruxtecan (T-DXd) 5.4 and 6.4 mg/kg showed robust antitumor activity in multiple cancer indications; however, T-DXd 5.4 mg/kg has not been evaluated in patients with previously treated human epidermal growth factor receptor 2–mutant ( HER2m; defined as single-nucleotide variants and exon 20 insertions) metastatic non–small-cell lung cancer (mNSCLC). METHODS: DESTINY-Lung02, a blinded, multicenter, phase II study, investigated T-DXd 5.4 mg/kg once every 3 weeks for the first time in previously treated (platinum-containing therapy) patients with HER2m mNSCLC and further assessed T-DXd 6.4 mg/kg once every 3 weeks in this population. The primary end point was confirmed objective response rate (ORR) per RECIST v1.1 by blinded independent central review. RESULTS: One hundred fifty-two patients were randomly assigned 2:1 to T-DXd 5.4 or 6.4 mg/kg once every 3 weeks. As of December 23, 2022, the median duration of follow-up was 11.5 months (range, 1.1-20.6) with 5.4 mg/kg and 11.8 months (range, 0.6-21.0) with 6.4 mg/kg. Confirmed ORR was 49.0% (95% CI, 39.0 to 59.1) and 56.0% (95% CI, 41.3 to 70.0) and median duration of response was 16.8 months (95% CI, 6.4 to not estimable [NE]) and NE (95% CI, 8.3 to NE) with 5.4 and 6.4 mg/kg, respectively. Median treatment duration was 7.7 months (range, 0.7-20.8) with 5.4 mg/kg and 8.3 months (range, 0.7-20.3) with 6.4 mg/kg. Grade ≥ 3 drug-related treatment-emergent adverse events occurred in 39 of 101 (38.6%) and 29 of 50 (58.0%) patients with 5.4 and 6.4 mg/kg, respectively. 13 of 101 (12.9%) and 14 of 50 (28.0%) patients had adjudicated drug-related interstitial lung disease (2.0% grade ≥ 3 in each arm) with 5.4 and 6.4 mg/kg, respectively. CONCLUSION: T-DXd demonstrated clinically meaningful responses at both doses. Safety profile was acceptable and generally manageable, favoring T-DXd 5.4 mg/kg.
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New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1)
Eisenhauer, E. A., Therasse, P., Bogaerts, J., Schwartz, L. H., Sargent, D., Ford, R., Dancey, J., Arbuck, S., Gwyther, S., Mooney, M., et al. (2009) · European Journal of Cancer · doi:10.1016/j.ejca.2008.10.026 · Cited by 29,534
Trastuzumab deruxtecan in previously treated HER2-positive breast cancer
Modi, S., Saura, C., Yamashita, T., Park, Y. H., Kim, S.-B., Tamura, K., Andre, F., Iwata, H., Ito, Y., Tsurutani, J., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa1914510 · Cited by 2,006
Self-citationTrastuzumab deruxtecan in previously treated HER2-positive gastric cancer
Shitara, K., Bang, Y.-J., Iwasa, S., Sugimoto, N., Ryu, M.-H., Sakai, D., Chung, H.-C., Kawakami, H., Yabusaki, H., Lee, J., et al. (2020) · New England Journal of Medicine · doi:10.1056/nejmoa2004413 · Cited by 1,333
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Trastuzumab Deruxtecan versus Trastuzumab Emtansine for Breast Cancer
Cortés, J., Kim, S.-B., Chung, W.-P., Im, S.-A., Park, Y. H., Hegg, R., Kim, M. H., Tseng, L.-M., Petry, V., Chung, C.-F., et al. (2022) · New England Journal of Medicine · doi:10.1056/nejmoa2115022 · Cited by 1,175
Self-citationTrastuzumab Deruxtecan in HER2 -Mutant Non–Small-Cell Lung Cancer
Li, B. T., Smit, E. F., Goto, Y., Nakagawa, K., Udagawa, H., Mazières, J., Nagasaka, M., Bazhenova, L., Saltos, A. N., Felip, E., et al. (2022) · New England Journal of Medicine · doi:10.1056/nejmoa2112431 · Cited by 1,021
Self-citationLi, B. T., Shen, R., Buonocore, D., Olah, Z. T., Ni, A., Ginsberg, M. S., Ulaner, G. A., Offin, M., Feldman, D., Hembrough, T., et al. (2018) · Journal of Clinical Oncology · doi:10.1200/jco.2018.77.9777 · Cited by 556
Siena, S., Di Bartolomeo, M., Raghav, K., Masuishi, T., Loupakis, F., Kawakami, H., Yamaguchi, K., Nishina, T., Fakih, M., Elez, E., et al. (2021) · The Lancet Oncology · doi:10.1016/s1470-2045(21)00086-3 · Cited by 422
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HER2-Mediated Internalization of Cytotoxic Agents in ERBB2 Amplified or Mutant Lung Cancers
Li, B. T., Michelini, F., Misale, S., Cocco, E., Baldino, L., Cai, Y., Shifman, S., Tu, H.-Y., Myers, M. L., Xu, C., et al. (2020) · Cancer Discovery · doi:10.1158/2159-8290.cd-20-0215 · Cited by 288
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The Journey of Antibody–Drug Conjugates: Lessons Learned from 40 Years of Development
Colombo, R., Tarantino, P., Rich, J. R., LoRusso, P. M., & de Vries, E. G. E. (2024) · Cancer Discovery · doi:10.1158/2159-8290.cd-24-0708 · Cited by 254
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
A B7H3-targeting antibody–drug conjugate in advanced solid tumors: a phase 1/1b trial
Ma, Y., Yang, Y., Huang, Y., Fang, W., Xue, J., Meng, X., Fan, Y., Fu, S., Wu, L., Zheng, Y., et al. (2025) · Nature Medicine · doi:10.1038/s41591-025-03600-2 · Cited by 122
Zongertinib in Previously Treated HER2 -Mutant Non–Small-Cell Lung Cancer
Heymach, J. V., Ruiter, G., Ahn, M.-J., Girard, N., Smit, E. F., Planchard, D., Wu, Y.-L., Cho, B. C., Yamamoto, N., Sabari, J. K., et al. (2025) · New England Journal of Medicine · doi:10.1056/nejmoa2503704 · Cited by 118
Self-citationSevabertinib in Advanced HER2 -Mutant Non–Small-Cell Lung Cancer
Le, X., Kim, T. M., Loong, H. H., Prelaj, A., Goh, B. C., Li, L., Fang, Y., Lu, S., Dong, X., Wu, L., et al. (2025) · New England Journal of Medicine · doi:10.1056/nejmoa2511065 · Cited by 70
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Metadata
- Authors
- Goto, K., Goto, Y., Kubo, T., Ninomiya, K., Kim, S.-W., Planchard, D., Ahn, M.-J., Smit, E. F., de Langen, A. J., Pérol, M., Pons-Tostivint, E., Novello, S., Hayashi, H., Shimizu, J., Kim, D.-W., Kuo, C.-H., Yang, J. C.-H., Pereira, K., Cheng, F.-C., Taguchi, A., Cheng, Y., Feng, W., Tsuchihashi, Z., & Jänne, P. A.
- Venue
- Journal of Clinical Oncology
- Published
- 2023-11-01
- Volume
- 41
- Issue
- 31
- Pages
- 4852-4863
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W4386592635
- Cited by
- 328
- References
- 21
- FWCI
- 51.79
- Type
- journal article
- Language
- en
- Open access
- hybrid
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- CoChat. (2026). Citation check: Trastuzumab Deruxtecan in Patients With HER2-Mutant Metastatic Non–Small-Cell Lung Cancer: Primary Results From the Randomized, Phase II DESTINY-Lung02 Trial. https://app.cochat.ai/papers/10.1200/jco.23.01361
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- Goto, K., Goto, Y., Kubo, T., Ninomiya, K., Kim, S.-W., Planchard, D., Ahn, M.-J., Smit, E. F., de Langen, A. J., Pérol, M., Pons-Tostivint, E., Novello, S., Hayashi, H., Shimizu, J., Kim, D.-W., Kuo, C.-H., Yang, J. C.-H., Pereira, K., Cheng, F.-C., . . . Jänne, P. A. (2023). Trastuzumab Deruxtecan in Patients With HER2-Mutant Metastatic Non–Small-Cell Lung Cancer: Primary Results From the Randomized, Phase II DESTINY-Lung02 Trial. Journal of Clinical Oncology. https://doi.org/10.1200/jco.23.01361
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