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NCT Number: NCT06786208

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Qiming Wang

Zhengzhou, Henan, 450000, China

Location contact

Qi Ming Wang, Doctor of Oncology

CONTACT

[email protected]

13783590691 ext. Medical Doctor

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sunvozertinib

Drug

sunvozertinb, a EGFR-TKI, 300mg QD oral

Primary outcomes

  1. Objective Response Rate (ORR)

    Time frame: 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 outcomes

  1. 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

    To assess anti-tumor activity of Sunvozertinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator

  2. 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.

    To assess anti-tumor activity of Sunvozertinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator

Sponsors and collaborators

Lead sponsor

Henan Cancer Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2027
First posted
Jan 22, 2025
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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