TROPION-Lung07: Phase III study of Dato-DXd plus pembrolizumab ± platinum-based chemotherapy as 1L therapy for advanced non-small-cell lung cancer

被引：4

作者：

Okamoto, Isamu ^{[1
]}

Kuyama, Shoichi ^{[2
]}

Girard, Nicolas ^{[3
]}

Lu, Shun ^{[4
]}

Franke, Fabio ^{[5
]}

Li, Ziming ^{[4
]}

Danchaivijitr, Pongwut ^{[6
]}

Han, Ji-Youn ^{[7
]}

Sun, Jong-Mu ^{[8
]}

Sugawara, Shunichi ^{[9
]}

Pan, Edward ^{[10
]}

Ren, Natalie ^{[11
]}

Chen, Aiying ^{[12
]}

Rajagopalan, Rachana ^{[13
]}

Lisberg, Aaron E. ^{[14
]}

机构：

[1] Kyushu Univ Hosp, Dept Resp Med, Fukuoka 8128582, Japan

[2] Iwakuni Clin Ctr, Dept Resp Med, Yamaguchi 7408510, Japan

[3] Inst Curie, Dept Med Oncol, F-75005 Paris, France

[4] Shanghai Jiao Tong Univ, Shanghai Chest Hosp, Shanghai Lung Canc Ctr, Sch Med, Shanghai 200030, Peoples R China

[5] Oncosite Ctr Pesquisa Clin, Dept Clin Res, BR-98700000 Ijui, Brazil

[6] Siriraj Hosp, Fac Med, Dept Med, Bangkok 10700, Thailand

[7] Natl Canc Ctr, Ctr Lung Canc, Goyang 10408, Gyeonggi, South Korea

[8] Sungkyunkwan Univ, Samsung Med Ctr, Sch Med, Dept Med, Seoul 06351, South Korea

[9] Sendai Kousei Hosp, Dept Pulm Med, Sendai, Japan

[10] Daiichi Sankyo Inc, Global Epidemiol, Basking Ridge, NJ 07920 USA

[11] Daiichi Sankyo Inc, Clin Dev Oncol, Basking Ridge, NJ USA

[12] Daiichi Sankyo Inc, Biostat & Data Management, Basking Ridge, NJ 07921 USA

[13] Daiichi Sankyo Inc, Clin Safety & Pharmacovigilance, London UB8 1DH, England

[14] Univ Calif Los Angeles UCLA, David Geffen Sch Med, Dept Med, Div Hematol & Oncol, Los Angeles, CA 90095 USA

来源：

FUTURE ONCOLOGY | 2024年 / 20卷 / 37期

关键词：

antibody-drug conjugate; Dato-DXd; datopotamab deruxtecan; non-small-cell lung cancer; TROPION; ANTIBODY-DRUG CONJUGATE; IMMUNOTHERAPY; DS-8201A; QLQ-C30;

D O I：

10.1080/14796694.2024.2409621

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

For patients with advanced/metastatic non-small-cell lung cancer (NSCLC) without actionable genomic alterations and low (<50%) PD-L1 expression, pembrolizumab plus pemetrexed and platinum chemotherapy is a preferred first-line treatment. These patients have comparatively worse outcomes than those with higher PD-L1 expression, underscoring the need for new combination strategies. Datopotamab deruxtecan (Dato-DXd), a TROP2-directed antibody-drug conjugate, has demonstrated encouraging antitumor activity and safety in this patient population. We describe the rationale and design of TROPION-Lung07, a randomized, open-label Phase III study assessing Dato-DXd in combination with pembrolizumab with/without platinum-based chemotherapy versus pembrolizumab plus pemetrexed and platinum-based chemotherapy in patients with advanced/metastatic non-squamous NSCLC without actionable genomic alterations and <50% PD-L1 expression. Primary study objectives are progression-free survival and overall survival.

引用

页码：2927 / 2936

页数：10

共 35 条

[1] THE EUROPEAN-ORGANIZATION-FOR-RESEARCH-AND-TREATMENT-OF-CANCER QLQ-C30 - A QUALITY-OF-LIFE INSTRUMENT FOR USE IN INTERNATIONAL CLINICAL-TRIALS IN ONCOLOGY [J].

AARONSON, NK ;

AHMEDZAI, S ;

BERGMAN, B ;

BULLINGER, M ;

CULL, A ;

DUEZ, NJ ;

FILIBERTI, A ;

FLECHTNER, H ;

FLEISHMAN, SB ;

DEHAES, JCJM ;

KAASA, S ;

KLEE, M ;

OSOBA, D ;

RAZAVI, D ;

ROFE, PB ;

SCHRAUB, S ;

SNEEUW, K ;

SULLIVAN, M ;

TAKEDA, F .

JOURNAL OF THE NATIONAL CANCER INSTITUTE, 1993, 85 (05) :365-376

[2] Datopotamab deruxtecan (Dato-DXd) vs docetaxel in previously treated advanced/metastatic (adv/met) non-small cell lung cancer (NSCLC): Results of the randomized phase III study TROPION-Lung01 [J].

Ahn, M. J. ;

Lisberg, A. ;

Paz-Ares, L. ;

Cornelissen, R. ;

Girard, N. ;

Pons-Tostivint, E. ;

Baz, D. Vicente ;

Sugawara, S. ;

Dols, M. Cobo ;

Perol, M. ;

Mascaux, C. ;

Poddubskaya, E. ;

Kitazono, S. ;

Hayashi, H. ;

Sands, J. ;

Hall, R. ;

Zhang, Y. ;

Zebger-Gong, H. ;

Uema, D. ;

Okamoto, I. .

ANNALS OF ONCOLOGY, 2023, 34 :S1305-S1306

[3]

American Cancer Society Internet, KEY STAT LUNG CANC

[4]

[Anonymous], EQ-5D

[5]

[Anonymous], 2022, NCCN Guidelines Version 1.2022 Breast Cancer Risk Reduction

[6] THE EORTC QLQ-LC13 - A MODULAR SUPPLEMENT TO THE EORTC CORE QUALITY-OF-LIFE QUESTIONNAIRE (QLQ-C30) FOR USE IN LUNG-CANCER CLINICAL-TRIALS [J].

BERGMAN, B ;

AARONSON, NK ;

AHMEDZAI, S ;

KAASA, S ;

SULLIVAN, M .

EUROPEAN JOURNAL OF CANCER, 1994, 30A (05) :635-642

[7] Symptoms and the early diagnosis of lung cancer [J].

Birring, SS ;

Peake, MD .

THORAX, 2005, 60 (04) :268-269

[8]

Borghaei H, 2023, J CLIN ONCOL, V41

[9] Combining DNA damaging therapeutics with immunotherapy: more haste, less speed [J].

Brown, Jessica S. ;

Sundar, Raghav ;

Lopez, Juanita .

BRITISH JOURNAL OF CANCER, 2018, 118 (03) :312-324

[10] Meaningful change: Defining the interpretability of changes in endpoints derived from interactive and mHealth technologies in healthcare and clinical research [J].

Byrom, B. ;

Breedon, P. ;

Tulkki-Wilke, R. ;

Platko, J., V .

JOURNAL OF REHABILITATION AND ASSISTIVE TECHNOLOGIES ENGINEERING, 2020, 7 :1-8

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