Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Boehringer Ingelheim
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Epidermal Growth Factor Receptor mutation detected by central laboratory analysis of tumour biopsy material.
Measurable disease according to RECIST 1.1.
Eastern Cooperative Oncology Group score of 0 or 1.
Age \>/= 18 years.
Life expectancy of at least three months.
Written informed consent that is consistent with International Conference on Harmonisation-Good Clinical Practice guidelines.
You may not be if
Prior chemotherapy for relapsed and/or metastatic NSCLC. Neoadjuvant/adjuvant chemotherapy is permitted if at least 12 months has elapsed between the end of chemotherapy and randomisation.
Prior treatment with Epidermal Growth Factor Receptor targeting small molecules or antibodies.
Radiotherapy or surgery (other than biopsy) within 4 weeks prior to randomisation.
Active brain metastases
Any other current malignancy or malignancy diagnosed within the past five years
Known pre-existing interstitial lung disease.
Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom.
History or presence of clinically relevant cardiovascular abnormalities.
Any other concomitant serious illness or organ system dysfunction.
Adequate absolute neutrophil count and platelet count
Adequate liver and kidney function
Active hepatitis B infection, active hepatitis C infection or known HIV carrier.
Clareo Health | BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation
