OSIRIS

Key outcome parameters

Primary endpoints:

• To provide the treating physician with access to complete osimertinib resistance analysis for all patients in the Netherlands that progress on osimertinib treatment
• To discuss these results in a MTB meeting and provide the treating physician with a recommendation for subsequent treatment

Secondary endpoints:

• To evaluate the concordance between the recommended subsequent treatment and the actually provided subsequent treatment
• To evaluate the concordance between osimertinib resistance in plasma using ctDNA and in tumor tissue
• To evaluate the success rate of molecular profiling on tumor tissue and ctDNA (test successfully performed or not)

Exploratory objectives:

• To evaluate the compliance to the MTB advise
• To monitor the clinical outcome of the subsequent line of systemic treatment
• To monitor the results of post-progression tumor biopsy and ctDNA results (limited to one line of systemic treatment following the MTB advise)
• To monitor the results of post-progression tumor biopsy and ctDNA results (limited to one line of systemic treatment following the MTB advise).
• To monitor the clinical outcome of the subsequent line of systemic treatment.
• To monitor the results of post-progression tumor biopsy and ctDNA results (limited to one line of systemic treatment following the MTB advise).

Intervention

N/A

Key inclusion criteria

Inclusion criteria

• Histologically confirmed metastatic NSCLC, characterized by a sensitizing EGFR mutation.
• Progressive disease, as assessed by the treating physician during osimertinib monotherapy.
• Eligible for subsequent treatment
• Willing to undergo a histological biopsy and withdrawal of a blood sample for ctDNA analysis.
• Technically possible to take a histological biopsy

Key exclusion criteria

Exclusion criteria

• Osimertinib discontinuation before blood draw and / or histological tumor biopsy
• Initiation of a new line of anticancer therapy before blood draw and / or histological tumor biopsy