NCT07806604Recruiting
Real World Study of Icotinib in Adjuvant Post Surgical Treatment for Stage IA2 High Risk to IB EGFR Mutant Non Small Cell Lung Cancer
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
Source: ClinicalTrials.gov · Last updated 8 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2572 (estimated)
- First submitted
- 2 Sept 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 28 Feb 2027
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Diseases
- Lung cancer
- NCT number
- NCT07806604
What you commit to
- Study type: Observational
- Planned participants: 2572
- From 1 Sept 2026 to the primary completion date, 28 Feb 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 2.Prior receipt of systemic anti-tumor therapy for NSCLC within 6 months before lung cancer surgery or before disease recurrence and metastasis.
Other illness
- 1\. A history of other malignancies within 5 years prior to lung cancer surgery, with the exception of curatively treated malignancies.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| Shanghai Pulmonary Hospital Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.