Clinical trial · Interventional
ctDNA-MRD Based Adjuvant Targeted Therapy for EGFR Positive Stage I Lung Adenocarcinomas
Circulating Tumor DNA (ctDNA)-Minimal Residual Disease (MRD) Based Adjuvant Targeted Therapy in EGFR Mutation-positive Stage I Lung Adenocarcinoma Patients After Complete Surgical Resection
NCT05079022CI-TRIAL-00054476unknownPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to determine the feasibility and effectiveness of ctDNA-MRD based adjuvant furmonertinib therapy in EGFR mutation-positive stage I lung adenocarcinoma patients after complete surgical resection.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of Lung | Lung Adenocarcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Furmonertinib | Drug | Firmonertinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Furmonertinib
- description
- ctDNA-MRD positive participants received 3 years of furmonertinib once daily as adjuvant therapy after radical surgery until disease progression or unacceptable toxicity occurs.
- interventionNames
- Drug: Furmonertinib
Primary outcomes (1)
- measure
- Clearance of ctDNA at 6 months
- timeFrame
- 6 months
- description
- To estimate the percentage of patients with undetectable ctDNA at 6 months after adjuvant furmonertinib therapy in stage I lung adenocarcinoma patients who underwent R0 resection and have postoperatively detectable ctDNA prior to adjuvant therapy.
Secondary outcomes (2)
- measure
- Relapse-free survival (RFS)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Stage I lung adenocarcinoma patients underwent complete surgical resection with negative margins (R0) and harbor sensitizing EGFR mutations (exon 19 and/or exon 21). 2. Positive ctDNA after surgery and prior to adjuvant therapy (4 weeks after surgery). 3. Completely recovered from surgery before adjuvant treatment and showed no signs of tumor recurrence in imaging. 4. Adequate organ function: 1) Hemoglobin ≥ 9.0 g/dL; 2)Absolute neutrophil count (ANC) ≥ 1500 cells/mm3; 3) Platelets ≥ 90,000/mm3; 4) AST, ALT ≤ 2.5 x ULN; 5) Total bilirubin ≤ 1.5 x ULN; 6) Serum creatinine ≤ 1.5x ULN and calculated creatinine clearance ≥ 60ml/min. 5. Age \>18 years old. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 7. Females must have a negative pregnancy test within 7 days prior to the start of dosing if of child-bearing potential. 8. Males and females of reproductive potential who are sexually active must agree to use adequate contraception prior to entry, during the process and 8 weeks after drug withdrawal. 9. Written informed consent. 10. Compliance with the protocol. 11. Ability to swallow the formulated product. Exclusion Criteria: 1. Any type of systemic anticancer therapy for lung adenocarcinomas, including chemotherapy, targeted therapy or immunotherapy. 2. Any prior local radiotherapy for lung adenocarcinomas. 3. Clinical objective evidence (pathology or imaging) to confirm disease recurrence before the start of adjuvant therapy. 4. Allergy to furmonertinib or any ingredients. 5. Past medical history of ILD, drug-induced ILD or any evidence of clinically active ILD; CT scan at baseline revealed the presence of idiopathic pulmonary fibrosis. 6. Any evidence of uncontrolled systemic diseases, including active infection, uncontrolled hypertension, unstable angina, angina within the last 3 months, congestive heart failure (≥ New York Heart Association \[NYHA\] Grade II), myocardial infarction (6 months before enrollment), severe arrhythmia requiring medical treatment, liver diseases, kidney diseases or metabolic diseases. 7. Known history of human immunodeficiency virus (HIV) infection. 8. Pregnant or lactating women. 9. History of neurological or psychiatric disorders, including epilepsy or dementia. 10. Other judgments by the Investigator that the patient should not participate in the study.
References
Publications (0)
Data not yet available
No reference posted for this study.