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Real-World Study of Icotinib as Adjuvant Therapy for Stage IA2-IA3 EGFR-Positive Non-Small Cell Lung Cancer with High-Risk Factors

Real-World Study of Icotinib as Adjuvant Therapy for Stage IA2-IA3 EGFR-Positive Non-Small Cell Lung Cancer with High-Risk Factors

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115161
Enrollment
Unknown
Registered
2025-12-23
Start date
2025-12-24
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung cancer

Interventions

Single arm:Postoperative adjuvant therapy was started within 4-12 weeks after operation. Patients received adjuvant therapy with icotinib for 5 years until the end of treatment or disease recurrence/p

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years, 2 cm, lymphatic invasion and/or poorly differentiated tumors (micropapillary type, solid/complex glands, cribriform structures), lymphovascular invasion (LVI), vascular tumor thrombus, unknown lymph node status (pNx), and air space dissemination (STAS).

Exclusion criteria

Exclusion criteria: 1. History of mixed small cell carcinoma and non-small cell carcinoma. 2. Incomplete resection (R1/R2) or pneumonectomy. 3. Evidence of severe or uncontrolled systemic disease, or active infection. 4. Have a history of other primary malignancies >= 5 years prior to the first study intervention, except for malignancies for which the purpose of treatment is to cure and there is no known active disease, with a low potential risk of recurrence. 5, Mean resting QTc interval > 470 ms, obtained from three ecg performed at screening. 6. Bone marrow reserve deficiency or organ dysfunction (patients do not meet the following conditions: blood routine examination: HB > 80 g/L; ANC > 1.0 x 10^9/L; PLT > 50 x 10^9/L; blood biochemical examination: ALT and AST < 2.5 times the upper limit of normal; Crea < 1.5 times the upper limit of normal). 7. Previously received any anti-cancer treatment (including chemotherapy, radiotherapy, immunotherapy and EGFR-TKIs) for non-small cell lung cancer.

Design outcomes

Primary

MeasureTime frame
3-year disease-free survival rate;

Secondary

MeasureTime frame
5-year disease-free survival rate;3-year overall survival rate;5-year overall survival rate;

Countries

China

Contacts

Public ContactJiao Peng

Beijing Hospital

jpjiaopeng@126.com+86 138 1163 3967

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026