Non Small Cell Lung CancerPhase 2WU-KONG35NCT07117890
Sunvozertinib Treatment in Untreated Advanced NSCLC With EGFR Uncommon Mutations
A Phase 2 study testing sunvozertinib 300mg and sunvozertinib 200mg in people with Non Small Cell Lung Cancer, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- sunvozertinib 300mg and sunvozertinib 200mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 7 Feb 2025to 30 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan university shanghai cancer center
Shanghai
jielei wang chief physician, 021-64175590, huixiaohua001@163.com
About this study
Official title: a Study of 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.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- sunvozertinib 300mg, sunvozertinib 200mg
- Keywords
- Non Small Cell Lung Cancer, Sunvozertinib, EGFR, EGFR uncommon mutation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sunvozertinib 300mgDrug
sunvozertinib monotherapy, 300mg QD
sunvozertinib 200mgDrug
sunvozertinib monotherapy, 200mg QD
| Study group | Role | What they receive |
|---|---|---|
| Sunvozertinib 300mg | Experimental | sunvozertinib monotherapy, 300mg QD Receives: Drug: sunvozertinib 300mg |
| sunvozertinib 200mg | Experimental | sunvozertinib monotherapy, 200mg QD Receives: Drug: sunvozertinib 200mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate(ORR)
Measured: from first dose to last dose ,up to 24 months
Secondary outcomes (2)
Progression-free survival (PFS)
Measured: 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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start7 Feb 2025
- Primary completion20 Feb 2027 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jialei Wang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117890
- Sponsor's protocol ID
- SUM-NSCLC-01
- Acronym
- WU-KONG35
- Status last verified
- Dec 2025
- First submitted
- 5 Aug 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- a Study of Sunvozertinib Treatment in Untreated Advanced NSCLC With EGFR Uncommon Mutations
- ClinicalTrials.gov ID
- NCT07117890
- Acronym / sponsor ID
- WU-KONG35 / SUM-NSCLC-01
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Non Small Cell Lung Cancer, Sunvozertinib, EGFR, EGFR uncommon mutation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 7 Feb 2025 (actual)
- Primary completion
- 20 Feb 2027 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sunvozertinib 300mg | Experimental | Drug: sunvozertinib 300mgsunvozertinib monotherapy, 300mg QD |
| sunvozertinib 200mg | Experimental | Drug: sunvozertinib 200mgsunvozertinib monotherapy, 200mg QD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sunvozertinib 300mgsunvozertinib monotherapy, 300mg QD | Drug | Sunvozertinib 300mg |
| sunvozertinib 200mgsunvozertinib monotherapy, 200mg QD | Drug | sunvozertinib 200mg |
Primary outcome
Objective Response Rate(ORR)
Time frame: from first dose to last dose ,up to 24 months
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sunvozertinib 300mg and sunvozertinib 200mg in people with Non Small Cell Lung Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jialei Wang (18017312369, wangjialei@shca.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate(ORR) (time frame: from first dose to last dose ,up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.