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Trial Title:
Sunvozertinib Combined With Chemotherapy for EGFRm After EGFR-TKI Treatment Failure：Phase I/II
NCT ID:
NCT06195189
Condition:
Non Small Cell Lung Cancer
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Non Small Cell Lung Cancer
Sunvozertinib
EGFR
chemotherapy
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Sunvozertinib
Description:
Sunvozertinib 200mg Quaquedie (QD)
Arm group label:
Sunvozertinib combined with chemotherapy (Pemetrexed +platinum)
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
Pemetrexed +platinum
Arm group label:
Sunvozertinib combined with chemotherapy (Pemetrexed +platinum)
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.
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 lung cancer (NSCLC) harboring epidermal growth
factor receptor (EGFR) sensitizing mutations who have progressed following standard TKI
therapy.
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
West China Hospital of Sichuan University
Address:
City:
Chengdu
Zip:
610044
Country:
China
Status:
Recruiting
Contact:
Last name:
You Lu, MD
Phone:
+8602885423571
Email:
radyoulu@hotmali.com
Contact backup:
Last name:
Feifei Na, MD
Phone:
18583988151
Email:
nafeifei@foxmail.com
Investigator:
Last name:
You Lu, MD
Email:
Principal Investigator
Investigator:
Last name:
Feifei Na, MD
Email:
Sub-Investigator
Start date:
February 29, 2024
Completion date:
February 1, 2026
Lead sponsor:
Agency:
Sichuan University
Agency class:
Other
Source:
Sichuan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06195189
