Real World Study of Icotinib in Adjuvant Post Surgical Treatment for Stage IA2 High Risk to IB EGFR Mutant Non Small Cell Lung Cancer

NCT07806604 · tracked via the Priya Life Science China tracker

Sponsor

Betta Pharmaceuticals Co., Ltd

Phase

Observational

Started

2026-09

Last updated

2026-09-08

Condition(s) studied

NSCLC (Non-small Cell Lung Cancer)

Investigational drug(s) / intervention(s)

Icotinib →Routine Observational

Icotinib: Icotinib，tablets, usually 125mg per dose (1 tablet), TID, orally

Routine Observational: Routine Observational Follow-up

Study summary

This is a multicenter, retrospective, observational real-world study designed based on real-world data. Eligible medical institutions that meet standardized data quality requirements and have an adequate sample size will be enrolled in this study. The treatment group consists of patients with completely resected (R0) stage IA2 high-risk to IB non-small cell lung cancer (NSCLC) harboring EGFR-sensitizing mutations who received adjuvant icotinib therapy after radical resection. The control group includes patients with completely resected (R0) stage IA2 high-risk to IB NSCLC with positive EGFR-sensitizing mutations who received routine observational follow-up after surgery. Propensity score-matched analyses will be conducted between the treatment and control groups to evaluate the efficacy and safety of adjuvant icotinib therapy in this patient population.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * 1\. Histologically confirmed primary non small cell lung cancer (NSCLC), predominantly non squamous histology (including adenocarcinoma or mixed carcinoma with a major adenocarcinoma component) * 2\. Pathologically confirmed stage IA2 high risk to IB NSCLC following complete surgical resection (R0) of primary lung cancer. Disease staging follows the 8th edition of the AJCC/UICC lung cancer staging system. * 3\. Post surgical tumour tissue specimens test positive for EGFR sensitizing mutations using an approved assay * 4\. Patients in the control group received postoperative observation without any anti tumour therapy prior to disease recurrence or metastasis. Exclusion Criteria: * 1\. A history of other malignancies within 5 years prior to lung cancer surgery, with the exception of curatively treated malignancies. * 2.Prior receipt of systemic anti-tumor therapy for NSCLC within 6 months before lung cancer surgery or before disease recurrence and metastasis.

Primary outcome measure(s)

Overall survival period（OS） — Data collection deadline (This study is a retrospective study and there is no predetermined evaluation time).The index date for this study is defined as 4 weeks following complete surgical resection (R0).

Trial sites (2)

Facility	City	Region	Status
Beijing Cancer Hospital	Beijing	Beijing Municipality	Recruiting
Shanghai Pulmonary Hospital	Shanghai	Shanghai Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07806604 on ClinicalTrials.gov ↗ ← All trials in China