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NCT Number: NCT07117890

Sunvozertinib Treatment in Untreated Advanced NSCLC With EGFR Uncommon Mutations

This study is a single arm study to access the anti-tumor efficacy and safety of sunvozertinib in untreated advanced NSCLC patients with EGFR uncommon mutations.

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Key information

Conditions

Non Small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fudan university shanghai cancer center

Shanghai, China

Location status: Recruiting

Location contact

jielei wang chief physician

CONTACT

[email protected]

021-64175590

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ≥18 years old
  • histologically or cytologically confirmed non-squamous NSCLC with documented EGFR uncommon mutations from a local laoratory. at least one EGFR uncommon mutation (excluding EGFR 19del/l858r/T790m/Ex 20ins ) or compund mutations with EGFR uncommon mutations.
  • predicted life expectancy ≥ 12 weeks.
  • patient must have measurable disease according to RECIST 1.1

Exclusion criteria

  • previos systemic anti-tumor therapy
  • a history of malignant tumors within 2years
  • any severa or poorly controlled systemic disease per investigator's judgement
  • active infections

Treatment and study plan

sunvozertinib 300mg

Drug

sunvozertinib monotherapy, 300mg QD

sunvozertinib 200mg

Drug

sunvozertinib monotherapy, 200mg QD

Primary outcomes

  1. Objective Response Rate(ORR)

    Time frame: from first dose to last dose ,up to 24 months

Secondary outcomes

  1. Progression-free survival (PFS)

    Time frame: from first dose to first documented disease progression assessed by investigator or death due to any cause up to 48 months ,up to 18 months

  2. Duration of Response (DoR)

    Time frame: for subject with PR or CR defined as the time from the first dose documentd CR or PR to disease progression or death up to 18 months

Study contacts

Contact information is provided by the study sponsor or research team.

Jialei Wang

CONTACT

[email protected]

18017312369

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

a Study of Sunvozertinib Treatment in Untreated Advanced NSCLC With EGFR Uncommon Mutations

Acronym: WU-KONG35

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2025
Registry last updated
Dec 24, 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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