An Open Label Study of BIBW 2992/Afatinib in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib

Sheba Medical Center

Status and phase: Unknown; Phase 2

Conditions: NSCLC

Treatments: Drug: Afatinib treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01932229

SHEBA-12-9547-JB-CTIL

Details and patient eligibility

About

Advanced lung cancer (non-small cell lung cancer) with a mutation in the EGFR (epidermal growth factor receptor) gene, which have disease progression after treatment with an EGFR inhibitor (erlotinib or gefitinib), and have progression of disease also after treatment with chemotherapy will be recruited. The trial has only one arm, of afatinib daily treatment. Blood and exhaled breath samples will be collected for investigations aiming to identify factors that predict response to afatinib.

Enrollment: 20 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Advanced NSCLC
• EGFR mutation or six months or longer benefit from EGFR TKIs
• Disease progression on chemotherapy, or inability to receive chemotherapy for medical reasons.
• Disease progression on EGFR TKI, or the presence of an EGFR mutation that does predicts for poor response to first generation EGFR TKIs.

Exclusion criteria

• Inability to take oral drugs

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Afatinib treatment

Experimental group

Treatment:

Drug: Afatinib treatment