NCT05221372

Brief Summary

The study is perfomed with adult patients with non-small cell lung cancer treated with tyrosine kinase inhibitor. The objective is to collect repeated samples of blood from patients (starting) on a tyrosine kinase inhibitor, for liquid mutation testing, and pharmacokinetic analysis.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,300

participants targeted

Target at P75+ for all trials

Timeline
56mo left

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Feb 2017Jan 2031

Study Start

First participant enrolled

February 2, 2017

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2022

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 3, 2022

Completed
8.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2031

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2031

Last Updated

February 18, 2022

Status Verified

February 1, 2022

Enrollment Period

13.9 years

First QC Date

January 10, 2022

Last Update Submit

February 2, 2022

Conditions

Non Small Cell Lung CancerLiquid BiopsyTyrosine Kinase Inhibitor

Outcome Measures

Primary Outcomes (2)

  • Relative presence of primary mutation and resistance mutations in plasma levels under treatment of a small molecule kinase inhibitor until progression of disease measured in variant allele frequency

    Describing the plasma levels of primary mutations and resistance mutations under treatment by sequentially measuring cell free tumor DNA. Different techniques will be used for the plasma mutation detection (ddPCR and NGS)

    10 years

  • Plasma concentrations of the small molecule kinase inhibitor during treatment until progression of disease

    Describing the plasma concentrations over time during treatment with a small molecule kinase inhibitor by sequentially measuring mean concentrations of the small molecule kinase inhibitor.

    10 years

Secondary Outcomes (6)

  • Time to progression or death under treatment with small molecule kinase inhibitor

    10 years

  • Overall survival

    10 years

  • Pharmacokinetics of intratumoral small molecule kinase inhibitors

    10 years

  • Correlation of mutation status in blood to (re)biopsy specimen results performed for standard-of-care.

    10 years

  • Correlation between the BMI of the patient and mean concentration of the small molecule kinase inhibitor

    10 years

  • +1 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with non-small cell lung cancer treated with a tyrosine kinase inhibitor

You may qualify if:

  • Age ≥ 18 years
  • Able to understand the written informed and able to give informed consent
  • Locally advanced or metastatic NSCLC with oncogenic driver mutation
  • Treatment with TKI according to standard of care

You may not qualify if:

  • Unable to draw blood for study purposes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus MC

Rotterdam, Netherlands

RECRUITING

Related Publications (2)

  • Steendam CMJ, Veerman GDM, Pruis MA, Atmodimedjo P, Paats MS, van der Leest C, von der Thusen JH, Yick DCY, Oomen-de Hoop E, Koolen SLW, Dinjens WNM, van Schaik RHN, Mathijssen RHJ, Aerts JGJV, Dubbink HJ, Dingemans AC. Plasma Predictive Features in Treating EGFR-Mutated Non-Small Cell Lung Cancer. Cancers (Basel). 2020 Oct 29;12(11):3179. doi: 10.3390/cancers12113179.

    PMID: 33138052RESULT

  • Ernst SM, Uzun S, Paats MS, van Marion R, Atmodimedjo PN, de Jonge E, van Schaik RHN, Aerts JGJV, von der Thusen JH, Dubbink HJ, Dingemans AC. Efficacy and Tolerability of Osimertinib and Sotorasib Combination Treatment for Osimertinib Resistance Caused by KRAS G12C Mutation: A Report of Two Cases. JCO Precis Oncol. 2023 Sep;7:e2300451. doi: 10.1200/PO.23.00451.

    PMID: 38096473DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Circulating tumor DNA on blood samples

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Anne-Marie Dingemans, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Marie Dingemans, MD, PhD

CONTACT

+31107040704a.dingemans@erasmusmc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 10, 2022

First Posted

February 3, 2022

Study Start

February 2, 2017

Primary Completion (Estimated)

January 1, 2031

Study Completion (Estimated)

January 1, 2031

Last Updated

February 18, 2022

Record last verified: 2022-02

Locations

NL(1)