Sunvozertinib Treatment in Untreated Advanced NSCLC With EGFR Uncommon Mutations

Not Applicable

Recruiting

• Conditions: Non Small Cell Lung Cancer
• Interventions: Drug: Sunvozertinib

• Registration Number: NCT07117890
• Lead Sponsor: Fudan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-07
• Status Verified: 2025-08
• Study First Submitted: 2025-08-05
• Study First Submitted QC: 2025-08-05
• Last Update Submitted: 2025-08-05
• Study First Posted: 2025-08-12
• Last Update Posted: 2025-08-12
• Primary Completion: 2027-02-20
• Study Completion: 2027-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. ≥18 years old
2. 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.
3. predicted life expectancy ≥ 12 weeks.
4. patient must have measurable disease according to RECIST 1.1

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sunvozertinib 300mg QD	Sunvozertinib	sunvozertinib monotherapy, 300mg QD

Primary Outcome Measures

Name	Time	Method
Objective Response Rate(ORR)	from first dose to last dose ,up to 24 months

Secondary Outcome Measures

Name	Time	Method
Progression-free survival (PFS)	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)	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

Trial Locations

Locations (1)

Fudan university shanghai cancer center; 🇨🇳 Shanghai, China