Status:
RECRUITING
Sunvozertinib Combined With Chemotherapy for EGFRm After EGFR-TKI Treatment Failure：Phase I/II
Lead Sponsor:
Sichuan University
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief 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 epid...
Detailed Description
This study is a single arm study to access the anti-tumor efficacy, safety and tolerability of Sunvozertinib combined with chemotherapy in patients with locally advanced or metastatic non-small-cell l...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
February 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06195189
Start Date
February 29 2024
End Date
February 1 2026
Last Update
March 25 2024
Active Locations (1)
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1
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610044