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Not yet recruiting NCT06786208

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

— Observational Non Small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sunvozertinib.
Who it may be relevant to
Registry conditions: Non Small Cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Drug Sunvozertinib
    sunvozertinb, a EGFR-TKI, 300mg QD oral

Primary outcome measures

  • Objective Response Rate (ORR) [Time frame: Time from first dose to last dose, up to 24 month]
Secondary outcome measures (2)
  • Progression-free survival (PFS) [Time frame: Time from first dose to first documented disease progression assessed by investigator or death due to any cause up to 24 month]
  • Overall survival (OS) [Time frame: Time Frame: Time from first dose to the death of the subject due to any cause assessed up to 36 months.]

Eligibility criteria

Inclusion criteria

  • To provide a signed and dated, written informed consent.
  • 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，at least one line chemotherapy and progress again
  • Predicted life expectancy ≥ 12 weeks
  • Adequate organ system function:
  • Patient must have measurable disease according to RECIST 1.1. -

Exclusion criteria

  • Spinal cord compression or meningeal metastasis
  • Not Recover from AEs caused by previous treatment yet
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Qiming Wang — Zhengzhou

Identifiers

NCT: NCT06786208 · 2024-388 · 2024-388

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗