Influence of the drug transporters ABCB1 and ABCG2 and enzyme CYP3A4 on survival outcome and pharmacokinetics in patients with non-small cell lung cancer treated with osimertinib

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON25881

Enrollment

500

Registered

2020-09-16

Start date

2020-07-25

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NSCLC

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Patients who are or have been treated with osimertinib for non-small cell lung cancer (NSCLC) and of whom blood has been withdrawn for study or diagnostic purposes are eligible for usage in this study.

Exclusion criteria

Exclusion criteria: No blood available for analysis

Design outcomes

Primary

Measure	Time frame
In the group with CNS metastases at baseline, primary outcome is the correlation of the SNPs C3435T (ABCB1), C421A and G34A (ABCG2) and CYP3A4*22 with treatment response of CNS metastases. PFS will be measured as time to cerebral progressive disease or death from any cause. In the group without CNS metastases at baseline, primary endpoint is correlation between the four SNPs and de novo occurrence of CNS metastases (defined as time to brain metastasis).	—

Measure

Time frame

In the group with CNS metastases at baseline, primary outcome is the correlation of the SNPs C3435T (ABCB1), C421A and G34A (ABCG2) and CYP3A4*22 with treatment response of CNS metastases. PFS will be measured as time to cerebral progressive disease or death from any cause. In the group without CNS metastases at baseline, primary endpoint is correlation between the four SNPs and de novo occurrence of CNS metastases (defined as time to brain metastasis).

—

Secondary

Measure	Time frame
Secondary endpoints are the correlations between presence of SNPs and OS, PFS independent of site (CNS or extracranial), toxicity, and pharmacokinetic parameters (AUC, Cmax, C/L) in the total cohort.	—

Contacts

Public ContactG.D. Marijn Veerman

Erasmus MC

g.veerman@erasmusmc.nl0641531792

Outcome results