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A Real-World Study on the Use of Fumavirine as Adjuvant Therapy for Non-Small Cell Lung Cancer After Surgery

Real-world Observational Clinical Study on the Use of Fumavir in Adjuvant Therapy for EGFR Mutation-Positive Non-Small Cell Lung Cancer After Radical Resection in Stages IA2 (High Risk) to IIIA

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600123375
Enrollment
Unknown
Registered
2026-04-26
Start date
2026-05-01
Completion date
Unknown
Last updated
2026-05-04

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

Conditions

After radical resection of tumors, patients with stage IA2 (with high-risk factors) - stage IIA NSCLC carrying EGFR sensitive mutation (19del/L858R) positivity must carry at least one high-risk factor, including the infiltration of the primary tumor (Ti) with a maximum diameter greater than 2cm, lymphatic/vascular infiltration, and high-grade pattern (= 20% solid, micropapillary, sieved or complex

Interventions

Case group:None

Sponsors

The Second Affiliated Hospital of Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: 1. Obtain written informed consent from the patient; 2. Male or female, aged >=18 years old; 3. Primary non squamous non-small cell lung cancer (NSCLC) diagnosed by histology; 4. Completed radical R0 resection for lung cancer (standard procedure); 5. Postoperative pathological staging is IA2 stage (with high-risk factors) - IIA stage (IASLC 9th edition TNM); 6. EGFR sensitive mutation positive (19del and/or L858R mutation) 7. Patients in stage IA must have at least one high-risk factor for recurrence, including infiltration of the primary tumor (Ti) with a maximum diameter greater than 2cm, lymphatic/vascular infiltration, and high-grade patterns (>=20% solid, micropapillary, sieved or complex glandular components).

Exclusion criteria

Exclusion criteria: 1. Presence of small cell lung cancer or mixed pathological types of NSCLC; 2. Prior to enrollment, received other EGFR TKI treatments 3. Patients assessed by researchers as unsuitable for inclusion, such as those with neurological disorders or metabolic disorders, suspected by physical or laboratory examinations of possible diseases, contraindications to the use of research drugs, or high risk of treatment-related complications; 4. Breastfeeding women; 5. History of other malignant tumors, or current concurrent malignant tumors (excluding malignant tumors that have undergone radical surgery and have not recurred within 5 years after surgery, such as cervical carcinoma in situ, basal cell carcinoma of the skin, and papillary thyroid carcinoma).

Design outcomes

Secondary

MeasureTime frame
disease-free survival rate;Incidence of adverse events;

Primary

MeasureTime frame
disease-free survival rate (3-year DFS rate);

Countries

China

Contacts

Public ContactZhang Qiang

The Second Affiliated Hospital of Shandong First Medical University

chinazq007@163.com+86 538 6237450

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: May 7, 2026