Track and treat in NSCLC (TATIN) - ctDNA guided treatment of early resistance to targeted treatment in patients with EGFR positive NSCLC

Phase 2

Recruiting

Conditions: Lung cancer
non-small cell lung cancer
10038666

Registration Number: NL-OMON48173

Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 30

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The number of patients with a resistant clone detected before radiological<br /><br>progression will be calculated as a percentage of total number of patients.<br /><br>The success rate of crizotinib treatment to eliminate resistance due to MET<br /><br>amplification will be calculated as the percentage of patients with<br /><br>disappearance of MET amplification in a subsequent ctDNA sample (not<br /><br>necessarily the first ctDNA following MET directed treatment) of the total<br /><br>number of patients with MET amplification detected in the ctDNA.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The Lag time between ctDNA based detection of a resistant clone and<br /><br>radiological progression will be calculated as a median with 95% confidence<br /><br>interval. This parameter will be calculated for all resistance mechanisms<br /><br>combined, as well as for the individual resistance mechanisms.<br /><br>The time to re-appearance of the MET amplification clone after successful<br /><br>elimination after crizotinib treatment will be calculated as a median with 95%<br /><br>confidence interval. </p><br>