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

JRCT ID: jRCT2080223197

Registered date:11/05/2016

Basic Information

• Recruitment status: completed
• Health condition(s) or Problem(s) studied: Patient with non-small-cell lung cancer who progressed disease after the previous treatment with EGFR TKI
• Date of first enrollment: 06/02/2017
• Target sample size: 60
• Countries of recruitment: Japan,Asia except Japan
• Study type: Interventional

Intervention(s)

investigational material(s)
Generic name etc : BI 836845
INN of investigational material : BI 836845
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : intravenous

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

Outcome(s)

Primary Outcome

efficacy
Disease control (DC), defined as complete response (CR), partial response (PR) or stable disease (SD)

Secondary Outcome

efficacy
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 minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. 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 criteria

1. 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

• Primary Sponsor: Nippon Boehringer Ingelheim Co., Ltd.
• Secondary Sponsor: -
• Source(s) of Monetary Support: -
• Secondary ID(s): NCT02191891,JapicCTI-163252