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Recruiting NCT07117890

Sunvozertinib Treatment in Untreated Advanced NSCLC With EGFR Uncommon Mutations

Phase II Interventional 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 300mg, sunvozertinib 200mg.
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

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

Overview

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.

Interventions

  • Drug sunvozertinib 300mg
    sunvozertinib monotherapy, 300mg QD
  • Drug sunvozertinib 200mg
    sunvozertinib monotherapy, 200mg QD

Primary outcome measures

  • Objective Response Rate(ORR) [Time frame: from first dose to last dose ,up to 24 months]
Secondary outcome measures (2)
  • 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]
  • 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]

Eligibility criteria

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

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

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Fudan university shanghai cancer center — Shanghai

Identifiers

NCT: NCT07117890 · SUM-NSCLC-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗