Real-world Study of Sunvozertinib Treatment in Advanced EGFR-Mutant NSCLC After EGFR-TKI Treatment Failure

Henan Cancer Hospital

Status: Not yet enrolling

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: Sunvozertinib

Study type: Observational

Funder types: Other

Identifiers

NCT06786208

2024-388 (Other Identifier)

Details and patient eligibility

About

Observe the efficacy and safety of sunvozertinib in the real world in the treatment of EGFRm aNSCLC patients with previous EGFR-TKI treatment

Full 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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

55 participants in 1 patient group

sunvozertinib treatment cohort

Description:

Patients: locally advanced or metastatic NSCLC with EGFR-sensitive mutations who have been previously treated with EGFR-TKIs and PD for last therapy. Investigators will assess patients whether to be suitable for sunvozertinib treatment. And this study will evaluate the safety and efficacy.

Treatment:

Drug: Sunvozertinib