NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-163252

Registered date:11/05/2016

Xentuzumab (BI 836845) Plus Afatinib in Patients With Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)

Basic Information

Recruitment status complete
Health condition(s) or Problem(s) studiedPatient with non-small-cell lung cancer who progressed disease after the previous treatment with EGFR TKI
Date of first enrollment06/2/2017
Target sample size60
Countries of recruitmentJapan, Asia except Japan
Study typeINTERVENTIONAL
Intervention(s)Intervention name : BI 836845 INN of the intervention : BI 836845 Dosage And administration of the intervention : intravenous Control intervention name : - INN of the control intervention : - Dosage And administration of the control intervention : -

Outcome(s)

Primary Outcomeefficacy Disease control (DC), defined as complete response (CR), partial response (PR) or stable disease (SD)
Secondary Outcomeefficacy Duration of objective response, defined as the duration of time from first objective response to the date of first objective tumour progression or death due to any cause

Key inclusion & exclusion criteria

Age minimum20
Age maximum
GenderBOTH
Include criteria1. Aged 20 years or older (Japan only) 2. Pathologically confirmed of advanced and/or metastatic stage IIIb/IV non-small cell carcinoma of lung 3. Activating EGFR mutation etc.
Exclude criteria1. For patient who has been treated with afatinib: last treatment at reduced dose below the assigned dose level (Part A only) or for patient who has been treated with afatinib: at reduced dose less than 30 mg/day (Parts A and B) 2. Patient whose disease progressed on insufficient dose of EGFR TKI immediately prior to study in the opinion of the investigator 3. Part B only: More than 2 prior EGFR TKI treatment regimens etc.

Related Information

Contact

public contact
Name Nippon Boehringer Ingelheim Co., Ltd. Medical Division
Address http://www.boehringer-ingelheim.co.jp/com/Home/Additional/contact.htm#08
Telephone
E-mail
Affiliation
scientific contact
Name Nippon Boehringer Ingelheim Co., Ltd. Medical Division
Address http://www.boehringer-ingelheim.co.jp/com/Home/Additional/contact.htm#08
Telephone
E-mail
Affiliation