Study ID: BI 1200.209
A single arm phase 4 study of afatinib in elderly (70+) patients with recurrent or stage 4 non-small cell lung cancer (NSCLC) whose tumors have common epidermal growth factor receptor (EGFR) mutations (exon 19 deletions or exon 21 L858R substitution mutations)
This clinical study seeks to determine the efficacy of the orally administered targeted therapy afatinib for patients aged 70 and older who have been diagnosed with stage 4 NSCLC and whose tumors have specific mutations. Participants take the pill daily for as long as they are benefiting from the study drug. If the benefit continues after the study closes, the sponsor will continue to provide participants with the drug.
- Pathologically confirmed diagnosis of recurrent or stage IV NSCLC (includes cytologically proven pleural effusion or pericardial effusion)
- Documented EGFR mutations (del 19 and/or L858R substitution)
- Age ≥ 70 years
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- No prior systemic therapy for metastatic or recurrent NSCLC
Treatment: oral afatinib (starting dose: 40mg/day) continuous until progression or occurrence of intolerable AE or end of trial.
- Must have been diagnosed with recurrent or stage 4 NSCLC harboring EGFR deletion 19 and/or L858R mutation
- Cannot have been treated previously with systemic therapy for metastatic or recurrent NSCLC