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ctDNA Guided Treatment of Early Resistance to Targeted Treatment

CompletedNA

Sponsor: The Netherlands Cancer Institute

Conditions: Carcinoma, Non-Small-Cell Lung

Interventions: ctDNA blood sample

Countries: Netherlands

The current strategy is to test for treatment resistance at the time of radiological progression and design subsequent treatment based on the mechanism of resistance. However, upon disease progression patients tend to deteriorate quickly and 30% - 40% of patients will not be in the clinical condition to receive next line treatment. Therefore, there is a potential for early resistance identification and directing treatment against it in order to improve patient outcome.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Histologically confirmed metastatic NSCLC, characterized by a sensitizing exon 19 deletion or exon 21 L858R EGFR mutation.
2. WHO performance status 0-2.
3. Eligible for osimertinib treatment according to the label and according to the treating physician.
4. Patients must be ≥18 years of age.

Exclusion Criteria:

1\. Patients with symptomatic central nervous system metastases who are neurologically unstable. Unstable brain metastases except for those who have completed definitive therapy and have had a stable neurological status for 2 weeks after completion of definitive therapy. Patients may be on corticosteroids to control brain metastases if they have been on a stable dose for 2 weeks prior to the start of study treatment and are clinically asymptomatic.

Locations (2)

Amsterdam, North Holland, Netherlands
Rotterdam, Netherlands