Clinical trial · Observational
Evaluate the Efficacy and Safety of Aspirin in Combination With Trametinib and Dabrafenib
An Observational Phase II Study to Evaluate the Efficacy and Safety of Aspirin in Combination With Trametinib and Dabrafenib in Advanced Non-small Cell Lung Cancer Patients With BRAF V600E Mutation
NCT05988697CI-TRIAL-00070422not yet recruitingClinicalTrials.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 observe the safety and efficacy of Aspirin combined with Trametinib and Dalafenib in the treatment of advanced BRAF V600E mutated non-small cell lung cancer (NSCLC)
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| BRAF V600E Mutation | — | UNRESOLVED | — |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Stage IIIB NSCLC | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV NSCLC | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combind asprin with Trametinib and Dabrafenib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Observation group
- description
- Primary IIIB-IV BRAF V600E mutated advanced non-small cell lung cancer in a population of patients with advanced lung cancer proposed to be treated with Trametinib， Dabrafenib and Asprin
- interventionNames
- Drug: Combind asprin with Trametinib and Dabrafenib
Primary outcomes (2)
- measure
- PFS
- timeFrame
- 3 years
- description
- Progression-free survival (PFS) was calculated in 36 patients treated with aspirin combined with Dabrafenib and Trametinib
- measure
- Proportion of patients with fever
- timeFrame
- C
- description
- Refers to the proportion of patients with fever from the beginning of treatment to the end of follow-up.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Inoperable stage IIIB-IV patients with non-small cell lung cancer; 2. BRAF V600E mutation; 3. Dabrafenib and Trametinib are planned for treatment, and the survival period is expected to be more than 3 months; 4. ECOG PS 0/1; 5. The diameter of the primary lesion should be at least 1cm; 6. Previous or current aspirin treatment was allowed Exclusion Criteria: 1. The patient is currently receiving other anticoagulant therapy; 2. The patient was previously treated with systemic anti-NSCLC; 3. The patient had other positive driver mutations, including EGFR, ALK, ROS1, MET14, RET, etc. 4. The patient had contraindications for dalafenib or trametinib and aspirin use; 5. Patients who refused follow-up visits;
References
Publications (0)
Data not yet available
No reference posted for this study.