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Clinical Trials in China / NCT06195189
Recruiting Phase 1/2

Sunvozertinib Combined With Chemotherapy for EGFRm After EGFR-TKI Treatment Failure:Phase I/II

NCT06195189 · tracked via the Priya Life Science China tracker
Sponsor
Sichuan University
Phase
Phase 1/2
Started
2024-02-29
Last updated
2026-05-08

Condition(s) studied

Non Small Cell Lung Cancer

Investigational drug(s) / intervention(s)

SunvozertinibChemotherapy

Sunvozertinib: Sunvozertinib 200mg Quaquedie (QD)

Chemotherapy: Pemetrexed +platinum

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
West China Hospital of Sichuan University Chengdu Sichuan Recruiting

More Sichuan University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06195189 on ClinicalTrials.gov ↗ ← All trials in China