Non Small Cell Lung Cancer
Conditions
Keywords
Non Small Cell Lung Cancer, Sunvozertinib, EGFR, chemotherapy
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 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.
Interventions
DRUGSunvozertinib
Sunvozertinib 200mg Quaquedie (QD)
DRUGChemotherapy
Pemetrexed +platinum
Sponsors
Sichuan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Time from first dose to last dose, or up to 24 month | 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
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DoR) | Time from first subject dose to study completion, or up to 36 month | To assess duration of response for subjects with CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator , defined as the time from the first documented CR or PR to disease progression or death |
| Progression-free survival (PFS) | Time from first subject dose to study completion, or up to 36 month | To assess progression-free survival of patients treated by sunvozertinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as first dose to first documented disease progression assessed by investigator or death due to any cause |
| Overall survival (OS) | Time from first subject dose to study completion, or up to 36 month | To assess overall survival, define as first dose to the death of the subject due to any cause |
| Adverse events (AEs) according to CTCAE 5.0 | From first dose until 28 days after the last dose, up to 24 month | Number of participants with adverse events (AEs) according to CTCAE 5.0 |
Countries
China
Contacts
Primary ContactLi Li, BA
Backup ContactFeifei Na, MD
Outcome results
None listed