Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

A Non-interventional, Real-world Study on the Adjuvant Treatment of Chinese EGFR-positive Stage IA NSCLC Patients With High-risk Factors Using Third-generation EGFR-TKIs.

30 juni 2026 uppdaterad av: First Affiliated Hospital of Guangxi Medical University

A Non-interventional, Real-World Study of Third-Generation EGFR-TKI Adjuvant Therapy in Chinese EGFR-Positive Stage IA Non-Small Cell Lung Cancer Patients With High-Risk Factors

This study aims to evaluate the real-world effectiveness and safety of third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs)-such as osimertinib, aumolertinib, and furmonertinib-as adjuvant therapy for patients with early-stage non-small cell lung cancer (NSCLC) in China.

Approximately 500 eligible patients are planned to be enrolled. All participants must have been diagnosed with Stage IA NSCLC (according to the 8th edition of the AJCC staging system) following surgical resection, harboring EGFR-sensitive mutations, and presenting with high-risk recurrence factors (e.g., poor differentiation, lymphovascular invasion, and spread through air spaces).

This is a non-interventional, real-world study that does not alter physicians' original prescribing habits or clinical management strategies. Patients will receive standard treatment with third-generation EGFR-TKIs according to routine clinical practice (typically for a duration of three years). The research team will periodically collect follow-up data, with a primary focus on postoperative disease-free survival (DFS) and drug safety profiles.

Through this investigation, we seek to determine whether this specific population of high-risk early-stage patients can derive clinical benefit from postoperative targeted therapy. The findings are expected to provide evidence to support the development of future clinical guidelines.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Beräknad)

500

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Kina
    • Guangxi
      • Nanning, Guangxi, Kina, 530021
        • The First Affiliated Hospital of Guangxi Medical University
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

This is a prospective, non-interventional, real-world study. The study population consists of 500 Chinese patients with stage IA NSCLC with high-risk factors and EGFR mutations. All participants have undergone or are planned to undergo surgical resection and are receiving or planned to receive third-generation EGFR-TKI adjuvant therapy according to the standard of care and the approved registration study protocol. Treatment duration is planned for up to 3 years until disease recurrence/progression, intolerable toxicity, withdrawal of consent, or completion of the 3-year treatment period. The study aims to collect data for final analysis without interfering with the patients' routine clinical treatment decisions.

Beskrivning

Inclusion Criteria:

  1. Age ≥ 18 years old
  2. Patients with IA-stage (8th edition of AJCC staging) non-small cell lung cancer (NSCLC) confirmed by histopathology and with high-risk factors
  3. EGFR mutation positive
  4. No previous systemic anti-tumor treatment
  5. Expected or already received surgical treatment
  6. Intended to receive or already received third-generation EGFR-TKI adjuvant therapy after surgery.

Exclusion Criteria:

  1. Small cell lung cancer
  2. With other malignant tumors that require treatment
  3. Pregnant or lactating women
  4. Those who the researchers consider not suitable to participate in this clinical trial.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
Observational Group
Third-generation EGFR-TKI adjuvant therapy for Chinese patients with stage IA EGFR-positive NSCLC who have high-risk factors
Läkemedel: Third-generation EGFR-TKI
This is an observational, non-interventional study. The interventions listed herein refer to routine standard adjuvant therapies administered entirely at the discretion and implementation of the attending physicians, without any interference from the study protocol. The research team is solely responsible for observing and collecting data, and does not participate in or influence patients' treatment decisions.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
3-Year Disease-Free Survival Rate
Tidsram: 3 years after 3rd generation EGFR-TKIs adjuvant therapy
The proportion of patients who did not PD or all-cause death after 3-years 3rd generation EGFR-TKIs adjuvant therapy
3 years after 3rd generation EGFR-TKIs adjuvant therapy

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
5-Year Disease-Free Survival rate
Tidsram: 5 years after 3rd generation EGFR-TKIs adjuvant therapy
The proportion of patients who did not PD or all-cause death after 3-years 3rd generation EGFR-TKIs adjuvant therapy
5 years after 3rd generation EGFR-TKIs adjuvant therapy
Disease-free Survival (DFS)
Tidsram: Approximately 5 years
From date of 3rd generation EGFR-TKIs adjuvant therapy started until date of disease recurrence or death (by any cause in the absence of recurrence).
Approximately 5 years
5-Year Overall Survival Rate
Tidsram: 5 years after 3rd generation EGFR-TKIs adjuvant therapy
The proportion of patients alive at 5 years
5 years after 3rd generation EGFR-TKIs adjuvant therapy
3-Year Overall Survival Rate
Tidsram: 3 years after 3rd generation EGFR-TKIs adjuvant therapy
The proportion of patients alive at 3 years
3 years after 3rd generation EGFR-TKIs adjuvant therapy
Overall Survival（OS）
Tidsram: Approximately 5 years
From date of 3rd generation EGFR-TKIs adjuvant therapy started until date of death (by any cause in the absence of recurrence).
Approximately 5 years
Incidence of Adverse Events
Tidsram: From the start of adjuvant therapy to 28 days after the end of treatment
The type, frequency and severity of adverse events during treatment (TEAE) and treatment-related adverse events (TRAE)
From the start of adjuvant therapy to 28 days after the end of treatment

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

First Affiliated Hospital of Guangxi Medical University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 september 2026

Primärt slutförande (Beräknad)

1 september 2031

Avslutad studie (Beräknad)

31 december 2032

Studieregistreringsdatum

Först inskickad

30 juni 2026

Först inskickad som uppfyllde QC-kriterierna

30 juni 2026

Första postat (Faktisk)

7 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

7 juli 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

30 juni 2026

Senast verifierad

1 juni 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2026-K0033

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

This is a single-center retrospective observational study. Due to practical limitations in data management infrastructure and the lack of specific funding allocated for data sharing activities, the research team does not plan to share individual participant data.

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Prenumerera