Clinical trial · Interventional
Adjuvant Targeted-therapy for Patients With Resected High-risk EGFR-mutant Stage IB-IIA Non-small Cell Lung Carcinoma
A Phase II, Single-armed Study to Assess the Efficacy and Safety of Furmonertinib in Patients With Epidermal Growth Factor Receptor Mutation Positive Stage IB-IIA Non-small Cell Lung Carcinoma, Following Complete Tumour Resection.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single-armed study designed to evaluate the safety and efficacy of adjuvant targeted-therapy in patients with epidermal growth factor receptor mutation positive stage IB-IIA non-small cell lung carcinoma and high-risk of recurrence following complete tumor resection. The primary endpoint: 2-year DFS rate; The second endpoint: DFS
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EGF-R Positive Non-Small Cell Lung Cancer | — | UNRESOLVED | — |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Furmonertinib | Drug | Firmonertinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- Furmonertinib (80 mg orally, once daily) for 3 years.
- interventionNames
- Drug: Furmonertinib
Primary outcomes (1)
- measure
- Disease Free Survival (DFS) rate at 2 years
- timeFrame
- From date of receiving therapy until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 4 years. Assessed at 2 years.
- description
- Assess the Efficacy of Adjuvant Furmonertinib as Measured by 2-year Disease Free Survival (DFS) rate.
Secondary outcomes (1)
- measure
- Disease Free Survival (DFS)
- timeFrame
- From date of receiving therapy until date of disease recurrence or death (by any cause in the absence of recurrence), up to approximately 4 years.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects aged ≥18 and ≤75 years old; 2. ECOG performance status score 0-1; 3. Stage ⅠB-ⅡA(according to the 8th Edition of the AJCC Staging system); 4. Complete surgical resection of the primary NSCLC is mandatory; 5. Histologically confirmed diagnosis of high-risk pathological subtype (micropapillary, solid pattern or spread through air spaces \[STAS\], etc.); 6. The tumour harbours one of the most common EGFR mutations (19del or L858R) ; 7. Normal organ and bone marrow function measured before the study as defined below: 1\) Hemoglobin (HGB)≥90g/L 2) White blood cell count (WBC) is 4.0\~10×10\^9/L 3) Absolute value of neutrophil (ANC)≥1.5×10\^9/L 4) Platelet (PLT) count≥100×109/L 5) Serum total bilirubin (TBIL)≤1.5×ULN 6) AST and/or ALT≤2.5×ULN 7) International normalized ratio(INR)≤1.5 and activated partial thromboplastin time (APTT) is normal 8) Serum creatinine (SCr)≤1.5 × ULN 8. No previous systemic anti-tumor therapy for malignant tumor, such as chemotherapy, radiotherapy or hormonotherapy. No history of other malignancies, subjects with prostate cancer who received hormone therapy and had more than 5 years of DFS were excluded; 9. Subjects have voluntarily participated, signed and dated informed consent. Exclusion Criteria: 1. Double primary lung cancer or multiple primary lung cancer; 2. Subjects with mental illness; 3. Presence or concomitant hemorrhagic diseases; 4. Pregnancy or lactation; 5. Known or suspected to be allergic to Furmonertinib and / or other components of their preparations.
References
Publications (0)
Data not yet available