Patient with non-small-cell lung cancer who progressed disease after the previous treatment with EGFR TKI
Conditions
Interventions
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 Investigationa
Sponsors
Nippon Boehringer Ingelheim Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Disease control (DC), defined as complete response (CR), partial response (PR) or stable disease (SD) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Asia except Japan, Japan
Outcome results
None listed