Clinical trial · Observational
The Efficacy of Double-dose Furmonertinib in the Treatment of Patients With Slow Osimertinib-resistant NSCLC
A Single-center, Prospective Study of the Efficacy of Double-dose Furmonertinib in the Treatment of Patients With Slow Osimertinib-resistant Non-small Cell Lung Cancer
- 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 study is a single-center, prospective, single-arm study of the efficacy of double-dose Furmonertinib in the treatment of patients with slow Osimertinib-resistant non-small cell lung cancer, mainly in patients with advanced non-small cell lung cancer with EGFR-sensitive mutations in stage IIIB or IV, slow drug resistance after treatment with Osimertinib, and no therapeutic target was found by secondary biopsy after drug resistance.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EGFR Gene Mutation | — | UNRESOLVED | — |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Non Small Cell Lung Cancer Stage IIIA | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Non-small Cell Lung Cancer Stage IV | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Furmonertinib | Drug | Firmonertinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Furmonertinib
- description
- The subjects will be treated with Furmonertinib (double dose, 160mg). The subjects were treated with drugs for 24 months until the tumor progressed (worsened) or died.
- interventionNames
- Drug: Furmonertinib
Primary outcomes (1)
- measure
- ORR
- timeFrame
- Observation time 1-2 months.
- description
- Objective response rate (ORR) including rate of CR and PR on based of RECIST 1.1
Secondary outcomes (4)
- measure
- OS
- timeFrame
- through study completion (36 months)
- description
- Overall survival (OS) defined as the median time from randomization to death from any cause.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥ 18 years old; 2. EGFRm NSCLC of local progression (IIIB stage) or metastasis (IV stage); 3. previously confirmed to have EGFR (Ex19del or L858R) mutation, or T790M, received Osimertinib treatment. According to Recist 1.1 imaging findings, the focus progressed slowly and there was no systemic explosive progress (definition of slow progress: disease control \> 6 months, slightly increased tumor load and symptom score ≤ 1); 4. patients who intend to use Furmonertinib (double dose, 160mg) anticancer therapy; 5. At least one tumor lesion in the patient can meet the following requirements: it has not been irradiated in the past and can be accurately measured, the longest diameter of the baseline phase is ≥ 10mm (in the case of lymph nodes, short axis ≥ 15mm is required), and the measurement method can be chest CT or PET-CT, as long as repeated measurements can be completed accurately; 6. No treatable target was found in the second biopsy after drug resistance; 7. The survival time was more than 3 months; Exclusion Criteria: 1. Patients who have been treated with Furmonertinib; 2. Patients who intend to use anticancer therapy other than Furmonertinib recently; 3. Contraindications for the use of Furmonertinib;
References
Publications (0)
Data not yet available