Clinical trial · Interventional
Sunvozertinib Combined With Chemotherapy for EGFRm After EGFR-TKI Treatment Failure:Phase I/II
Sunvozertinib Combined With Chemotherapy for EGFRm + Locally Advanced or Metastasis NSCLC Patients After EGFR-TKI Treatment Failure:Phase I/II (WU-KONG36)
NCT06195189CI-TRIAL-00110977WU-KONG36recruitingPhase 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)
To access the anti-tumor efficacy, safety and tolerability of Sunvozertinib combined with chemotherapy in patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) sensitizing mutations who have progressed following standard TKI therapy.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Sunvozertinib | Drug | Sunvozertinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sunvozertinib combined with chemotherapy (Pemetrexed +platinum)
- description
- Sunvozertinib 200mg Quaquedie (QD) combined with chemotherapy (Pemetrexed +platinum)
- interventionNames
- Drug: Sunvozertinib
- Drug: Chemotherapy
Primary outcomes (1)
- measure
- Objective Response Rate (ORR)
- timeFrame
- Time from first dose to last dose, or up to 24 month
- description
- To assess sunvozertinib overall response rate according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as the proportion of subjects who have a complete response (CR) or a partial response (PR)
Secondary outcomes (4)
- measure
- Duration of Response (DoR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. To provide a signed and dated, written informed consent. 2. 80≥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, and exon 20 T790M mutated. 5. Predicted life expectancy ≥ 12 weeks 6. EGFR-TKI resistance or intolerant to standard EGFR TKIs therapy. 7. No previous systemic chemotherapy for advanced or metastatic disease. 8. Adequate organ system function: 9. Patient must have measurable disease according to RECIST 1.1. 10. Patients with stable or pre-treated brain metastasis (BM) can be enrolled Exclusion Criteria: 1. Spinal cord compression or meningeal metastasis 2. A history of malignant tumors within 2 years. 3. With known resistant mutations that have approved target therapy 4. Recover from AEs caused by previous treatment 5. A history of stroke or intracranial hemorrhage within 6 months prior to initial dosing. 6. 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.