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OSIRIS

Osimertinib resistance analysis in patients with EGFR mutation positive non-small-cell lung carcinoma that have progressed on osimertinib treatment

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Enrollment

Recruiting

No. of patients

8 / 200

Population

Patients with EGFR mutation positive non-small-cell lung carcinoma (NSCLC) that progress on osimertinib treatment

Design

A multi-center prospective biomarker study

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

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