Clinical trial · Observational
Real-world Study of Sunvozertinib Treatment in Advanced EGFR-Mutant NSCLC After EGFR-TKI Treatment Failure
Real-world Study of Sunvozertinib Treatment in Locally Advanced or Metastatic EGFR-Mutant NSCLC After EGFR-TKI Treatment Failure
NCT06786208CI-TRIAL-00084925not 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)
Observe the efficacy and safety of sunvozertinib in the real world in the treatment of EGFRm aNSCLC patients with previous EGFR-TKI treatment
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 |
|---|---|---|---|
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sunvozertinib | Drug | Sunvozertinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- sunvozertinib treatment cohort
- description
- Patients: locally advanced or metastatic NSCLC with EGFR-sensitive mutations who have been previously treated with EGFR-TKIs and PD for last therapy. Investigators will assess patients whether to be suitable for sunvozertinib treatment. And this study will evaluate the safety and efficacy.
- interventionNames
- Drug: Sunvozertinib
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Time from first dose to last dose, up to 24 month
- description
- assess the proportion of subjects who have a complete response (CR) or a partial response (PR)\]
Secondary outcomes (2)
- measure
- Progression-free survival (PFS)
- timeFrame
- Time from first dose to first documented disease progression assessed by investigator or death due to any cause up to 24 month
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. To provide a signed and dated, written informed consent. 2. Age ≥ 18 years old 3. Histologically or cytologically confirmed non-squamous NSCLC with documented EGFR mutations from a local laboratory 4. EGFR-sensitive mutations including exon 19 deletion and exon 21 L858R mutated，at least one line chemotherapy and progress again 5. Predicted life expectancy ≥ 12 weeks 6. Adequate organ system function: 7. Patient must have measurable disease according to RECIST 1.1. - Exclusion Criteria: 1. Spinal cord compression or meningeal metastasis 2. Not Recover from AEs caused by previous treatment yet 3. A history of stroke or intracranial hemorrhage within 6 months prior to initial dosing. 4. Any severe or poorly controlled systemic disease per investigator's judgment .active infections, including but not limited to hepatitis B (HBV), hepatitis C HCV, and human immunodeficiency HIV
References
Publications (0)
Data not yet available
No reference posted for this study.