MedDataX Logo

Sunvozertinib Treatment in Untreated Advanced NSCLC With EGFR Uncommon Mutations

NCT ID: NCT07117890

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-07

Study Completion Date

2027-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non Small Cell Lung Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Non Small Cell Lung Cancer Sunvozertinib EGFR EGFR uncommon mutation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Sunvozertinib 300mg

sunvozertinib monotherapy, 300mg QD

Group Type EXPERIMENTAL

sunvozertinib 300mg

Intervention Type DRUG

sunvozertinib monotherapy, 300mg QD

sunvozertinib 200mg

sunvozertinib monotherapy, 200mg QD

Group Type EXPERIMENTAL

sunvozertinib 200mg

Intervention Type DRUG

sunvozertinib monotherapy, 200mg QD

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

sunvozertinib 300mg

sunvozertinib monotherapy, 300mg QD

Intervention Type DRUG

sunvozertinib 200mg

sunvozertinib monotherapy, 200mg QD

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Fudan University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jialei Wang

Chief physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fudan university shanghai cancer center

Shanghai, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jialei Wang

Role: CONTACT

Phone: 18017312369

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

jielei wang chief physician

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SUM-NSCLC-01

Identifier Type: -

Identifier Source: org_study_id