Sunvozertinib Combined With Chemotherapy for EGFRm After EGFR-TKI Treatment Failure：Phase I/II
Recruiting now · Phase 1/Phase 2
Conditions studied: Non Small Cell Lung Cancer
In brief
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.
Key facts
- Study ID
- NCT06195189
- Run by
- Sichuan University
- People needed
- 40
- Starts
- 2024-02-29
- Expected to finish
- 2028-12-30
- Last updated by the study team
- 2026-05-08
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- To provide a signed and dated, written informed consent.
- 80≥Age ≥ 18 years old
- Histologically or cytologically confirmed non-squamous NSCLC with documented EGFR mutations from a local laboratory
- EGFR-sensitive mutations including exon 19 deletion and exon 21 L858R mutated, and exon 20 T790M mutated.
- Predicted life expectancy ≥ 12 weeks
- EGFR-TKI resistance or intolerant to standard EGFR TKIs therapy.
- No previous systemic chemotherapy for advanced or metastatic disease.
- Adequate organ system function:
- Patient must have measurable disease according to RECIST 1.1.
- Patients with stable or pre-treated brain metastasis (BM) can be enrolled
You may not qualify if…
- Spinal cord compression or meningeal metastasis
- A history of malignant tumors within 2 years.
- With known resistant mutations that have approved target therapy
- Recover from AEs caused by previous treatment
- A history of stroke or intracranial hemorrhage within 6 months prior to initial dosing.
- 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)
Where it is running
- West China Hospital of Sichuan University — Chengdu, Sichuan, China (enrolling)
Full record on ClinicalTrials.gov
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