Non Small Cell Lung Cancer
Conditions
Keywords
Non Small Cell Lung Cancer, Sunvozertinib, EGFR
Brief summary
Observe the efficacy and safety of sunvozertinib in the real world in the treatment of EGFRm aNSCLC patients with previous EGFR-TKI treatment
Detailed description
Locally advanced or metastatic NSCLC with EGFR-sensitive mutations who have been previously treated with EGFR-TKIs and PD for last therapy can be involved in this study. Investigators will assess patients whether to be suitable for sunvozertinib treatment. And this study will evaluate the safety and efficacy.
Interventions
DRUGSunvozertinib
sunvozertinb, a EGFR-TKI, 300mg QD oral
Sponsors
Henan Cancer Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. To provide a signed and dated, written informed consent. 2. 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，at least one line chemotherapy and progress again 5. Predicted life expectancy ≥ 12 weeks 6. Adequate organ system function: 7. Patient must have measurable disease according to RECIST 1.1. -
Exclusion criteria
1. Spinal cord compression or meningeal metastasis 2. Not Recover from AEs caused by previous treatment yet 3. A history of stroke or intracranial hemorrhage within 6 months prior to initial dosing. 4. 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, up to 24 month | assess the proportion of subjects who have a complete response (CR) or a partial response (PR)\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | Time from first dose to first documented disease progression assessed by investigator or death due to any cause up to 24 month | To assess anti-tumor activity of Sunvozertinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator |
| Overall survival (OS) | Time Frame: Time from first dose to the death of the subject due to any cause assessed up to 36 months. | To assess anti-tumor activity of Sunvozertinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator |
Countries
China
Outcome results
None listed