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

Phase 1
Completed
Conditions
Patient with non-small-cell lung cancer who progressed disease after the previous treatment with EGFR TKI
Registration Number
JPRN-jRCT2080223197
Lead Sponsor
ippon Boehringer Ingelheim Co., Ltd.
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
completed
Sex
All
Target Recruitment
60
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

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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