Sunvozertinib Treatment in Untreated Advanced NSCLC With EGFR Uncommon Mutations

NCT07117890 | Recruiting Phase 2

• 1 other identifier: SUM-NSCLC-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Non Small Cell Lung Cancer

Keywords

Non Small Cell Lung Cancer; Sunvozertinib; EGFR; EGFR uncommon mutation

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate(ORR)

  from first dose to last dose ,up to 24 months

Secondary Outcomes (2)

• 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

Study Arms (2)

Sunvozertinib 300mg

EXPERIMENTAL

sunvozertinib monotherapy, 300mg QD

Drug: sunvozertinib 300mg

sunvozertinib 200mg

EXPERIMENTAL

sunvozertinib monotherapy, 200mg QD

Drug: sunvozertinib 200mg

Interventions

sunvozertinib 300mg DRUG

sunvozertinib monotherapy, 300mg QD

Sunvozertinib 300mg

sunvozertinib 200mg DRUG

sunvozertinib monotherapy, 200mg QD

sunvozertinib 200mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan university shanghai cancer center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Jialei Wang

CONTACT

18017312369; wangjialei@shca.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 12, 2025
• Study Start: February 7, 2025
• Primary Completion (Estimated): February 20, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)