臨床研究等提出・公開システム

Phase II study of Trastuzumab Deruxtecan (DS-8201a) in subjects with non-small cell lung cancer (NSCLC)

DESTINY-Lung01

DAIICHI SANKYO Co.,Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

dsclinicaltrial@daiichisankyo.co.jp

DAIICHI SANKYO Co.,Ltd.

1-2-58, Hiromachi, Shinagawa-ku, Tokyo

+81-3-6225-1111

dsclinicaltrial@daiichisankyo.co.jp

completed

May. 21, 2018

Interventional

Multicenter, open-label, 2-cohort, phase II trial

treatment purpose

2

1. Age >= 20 years old.
2. Pathologically documented unresectable and/or metastatic non-squamous NSCLC.
3. Has relapsed from or is refractory to standard treatment or for which no standard treatment is available.
4. For Cohort 1 and Cohort 1a only: HER2-overexpression (IHC 2+ or 3+) status must be assessed and confirmed from an archival tumor tissue sample.
5. For Cohort 2 only: Documented any known activating HER2 mutation from an archival tumor tissue sample.
6. Presence of at least 1 measurable lesion assessed by the investigator based on RECIST ver. 1.1.
7. Is willing and able to provide an adequate archival tumor tissue sample.
8. Is willing to undergo a tissue biopsy, after the completion of the most recent treatment regimen.

1. Was previously treated with HER2-targeted therapies, except for pan-HER class tyrosine kinase inhibitors.
2. For Cohort 1 and Cohort 1a only: Has known HER2 mutation.
3. Has an uncontrolled or significant cardiovascular disease
4. Has a medical history of clinically significant lung disease.

Both

HER2-over-expressing or HER2-mutated unresectable and/or metastatic non-squamous NSCLC

investigational material(s)
Generic name etc : DS-8201a
INN of investigational material : trastuzumab deruxtecan
Therapeutic category code : 42- Antineoplastic agents
Dosage and Administration for Investigational material : Intravenous

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

efficacy
Objective response rate (ORR)
ORR assessed by independent central imaging facility review based on RECIST ver. 1.1.

efficacy
pharmacokinetics
safety
Duration of response, disease control rate, progression free survival, overall survival, safety, pharmacokinetics

April. 24, 2018