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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

RecruitingN/A

Sponsor: Betta Pharmaceuticals Co., Ltd.

Conditions: NSCLC (Non-small Cell Lung Cancer)

Interventions: Icotinib, Routine Observational

Countries: China

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (2)

Beijing, Beijing Municipality, China
Shanghai, Shanghai Municipality, China