A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progressionon Osimertinib.
A Pilot Study of Dacomitinib With or Without Osimertinib for Patients With Metastatic EGFR Mutant Lung Cancers With Disease Progressionon Osimertinib.
The purpose of this study is to assess whether dacomitinib after osimertinib is effective in participants with metastatic EGR-mutant lung cancers.
Inclusion Criteria:
Written informed consent
Advanced biopsy-proven metastatic non-small cell lung cancer
Somatic activating mutation in EGFR in a tumor biopsy or plasma cfDNA liquid biopsy
Prior treatment with osimertinib with response followed by disease progression
No prior first or second generation EGFR inhibitor treatment (gefitinib, afatinib, erlotinib)
Archival tissue available from a tumor biopsy done after disease progression on osimertinib or willing to undergo a tumor biopsy or liquid biopsy after disease progression on osimertinib prior to study initiation
Measurable (RECIST 1.1) indicator lesion not previously irradiated
Karnofsky performance status (KPS) >/= 70%
Age >/= 18 years old
Ability to swallow oral medication
Adequate organ function
Exclusion Criteria: