Adjuvant Treatment Based on MRD for EGFR Mutant NSCLC
ConditionMRD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorGuangdong Association of Clinical Trials
About this trial
A prospective, multicenter clinical study designed to explore the efficacy of postoperative adjuvant EGFR-TKIs therapy based on MRD status in patients with stage IB-IIIB EGFR-mutant non-squamous non-small cell lung cancer (non-squamous NSCLC). Primary endpoints include 3-year Disease-Free Survival rate (3y-DFS) and median disease-free survival (mDFS).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Written informed consent provided.
Males or females aged ≥18 years, < 80 years.
Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
Target population is completely resected pathological stage IB-IIIB NSCLC with EGFR exon 19 deletions, L861Q mutation, G719X mutation and exon 21 L858R activating mutation.
Disqualifiers
Known severe hypersensitivity to icotinib, osimertinib or any of the excipients of this product.
Inability to comply with protocol or study procedures.
A serious concomitant systemic disorder that, in the opinion of the investigator, would compromise the patient's ability to complete the study.
A serious cardiac condition, such as myocardial infarction within 6 months, angina, or heart disease.
Trial design
Design model
Parallel
Treatments tested in this trial
Adjuvant treatment for MRD positivity
GeneticThe MRD positive group would receive icotinib as adjuvant treatment. When the peripheral blood MRD turned negative, the subjects entered the drug withdrawal observation period. When the MRD turned positive again, the subjects resumed icotinib treatment. If EGFR T790M mutation was found, researchers would resume medication and choose osimertinib therapy.
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: MRD Positivity Post OperationExperimental treatment 1 intervention
Group B: MRD Negativity Post OperationNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Disease Free Survival
Disease free survival (DFS)- defined as the time from operation to the first documented disease progression or death, whichever occurs first.
Time frame
From date of opeartion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months2
3 yeas DFS rate
To compare 3y-DFS rates between the two arms
Time frame
From date of opeartion until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 monthsSecondary outcomes
1
Overall survival
To evaluate the overall survival of both arms
Time frame
OS is defined as the time from opeartion to death, regardless of disease recurrence, assessed up to 100 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov