臨床研究等提出・公開システム

A Randomized, Double-Blind, Placebo-controlled Phase III Study of DE-766 with Cisplatin/Vinorellbine plus Concurrent Thoracic Radiotherapy in Patients with Unresectable Locally Advanced Squamous Cell Lung Cancer

Stydy of DE-766 in Patients with Unresectable Locally Advanced Squamous Cell Lung Cancer

DAIICHI SANKYO CO., Ltd.

http://www.daiichisankyo.co.jp/corporate/rd/measure/clinical/index.html

Interventional

Multi-center, Double-Blind, Randomized, Placebo-controlled

3

1) Patients with stage IIIA or IIIB of squamous cell lung cancer
2) Patients with unresectable squamous cell lung cancer
3) Patients who are judged suitable for radical radiotherapy
4) Patients who have received no prior treatment for lung cancer

1) Patients with contralateral hilar lymph node metastasis
2) Patients with obvious pulmonary fibrosis or interstitial pneumonitis on chest CT scans
3) Patients with a severe pulmonary disease such as intense pulmonary emphysema, serious chronic bronchitis, or serious bronchial asthma
4) Patients with severe infection
5) Patients with severe cardiovascular disease
6) Patients with uncontrolled diabetes mellitus
7) Patients with another active malignancy
8) Patients with a history of prior radiotherapy to chest
9) Patients who have received with any EGFR targeted drug at any time
10) Patients who received another investigational drug within 4 weeks prior to randomization.

Both

Unresectable Locally Advanced Squamous Cell Lung Cancer

investigational material(s)
Generic name etc : DE-766
INN of investigational material : Nimotuzumab
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Once weekly intravenous administration of 200 mg or placebo for 16 weeks

Overall survival

Safety, Torelability, Progression free survival, Local controll duration, First relapse site, Response rate, Disease control rate
NCI-CTCAE(ver4.0), RECIST(ver1.1)