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RECRUITING
NCT07806604

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

Sponsor: Betta Pharmaceuticals Co., Ltd.

View on ClinicalTrials.gov

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.

Official 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

2572

Start Date

2026-09

Completion Date

2027-06

Last Updated

2026-09-08

Healthy Volunteers

No

Interventions

DRUG

Icotinib

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

OTHER

Routine Observational

Routine Observational Follow-up

Locations (2)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China