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

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.

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Key information

Conditions

NSCLC (Non-small Cell Lung Cancer) Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Cancer Hospital, Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Icotinib

Drug

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

Routine Observational

Other

Routine Observational Follow-up

Primary outcomes

Overall survival period（OS）

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Betta Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

Multicenter, Retrospective, Observational Study of Icotinib for Post-Surgical Adjuvant Therapy in Stage IA2 High-Risk to IB Non-Small-Cell Lung Cancer With Positive EGFR-Sensitive Mutations

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Sep 8, 2026
Registry last updated: Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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