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
Qualifiers
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
Treatments tested in this trial
- Adjuvant treatment for MRD positivity
Treatment groups
180 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov