Adjuvant EGFR-TKI Therapy After Surgery for EGFR-Mutant High-Risk Stage IA2-IIB NSCLC
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
This prospective, multicenter patient registry is designed to evaluate the effectiveness and safety of postoperative EGFR tyrosine kinase inhibitor (EGFR-TKI) therapy in patients with completely resected EGFR-mutant high-risk stage IA2 to stage IIB non-small cell lung cancer. Approximately 100 adults aged 18 to 75 years will be enrolled across five participating centers. Eligible tumors must harbor an EGFR alteration, including exon 19 deletion, L858R, exon 20 insertion, or PACC mutations. High-risk stage IA2 disease is defined by at least one protocol-specified high-risk feature, including an invasive tumor component greater than 2 cm, lymphovascular invasion, a high-grade histologic pattern (at least 20% solid, micropapillary, cribriform, or complex glandular components), spread through air spaces, or sublobar resection. Postoperative management, including adjuvant EGFR-TKI therapy or observation, is determined by routine clinical practice and patient/physician preference rather than assigned by the study. Participants are categorized by EGFR mutation type into common sensitizing mutations (Group A) and uncommon/resistant mutations (Group B), with clinical stage used for stratified analyses. The primary outcome is disease-free survival (DFS). Secondary outcomes include 2-, 3-, and 5-year DFS rates, overall survival (OS), 5-year OS, health-related quality of life measured using the SF-36, and safety outcomes. Tumor tissue and serial blood samples are collected for genomic and exploratory biomarker analyses.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Wiek 18-75 lat, mężczyzna lub kobieta, ze świadomą zgodą
- •Potwierdzony histologicznie rak płuca (niedrobnokomórkowy), stopień zaawansowania IA2 do IIB po operacji
- •Mutacja genu EGFR potwierdzona w laboratorium (usunięcie egzonu 19, L858R, wstawka egzonu 20 lub mutacja PACC)
- •Całkowite chirurgiczne usunięcie guza z czystymi brzegami, bez pozostałości nowotworu
- •Dobry stan ogólny (ECOG 0-1)
- •Prawidłowe wyniki badań krwi (hemoglobina, leukocyty, trombocyty, funkcja nerek i wątroby)
- •Brak wcześniejszego leczenia przeciwnowotworowego (chemioterapia, radioterapia, terapia celowana)
- •Dostępne próbki tkanki guza chęć uczestnictwa w badaniach genetycznych i pobieraniu krwi
✗ Disqualifies
- •Przeciwwskazania do znieczulenia lub operacji
- •Ciężkie choroby układowe niezgodne z udziałem w badaniu
- •Ciąża lub karmienie piersią
- •Aktywne uzależnienie od alkoholu lub narkotyków
- •Niezdolność do wyrażenia świadomej zgody
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- September 23, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (1)
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Trial contact
Wei Ping, Dr.
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/24/2026.
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