Potentially Resectable EGFR Exon 20 Insertion Non-Small Cell Lung CancerPhase 2NCT07274761
Neoadjuvant Sunvozertinib in Stage II-IIIB Non-small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutation.
A Phase 2 study testing Sunvozertinib in people with Potentially Resectable EGFR Exon 20 Insertion Non-Small Cell Lung Cancer and Non Small Cell Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China at 1 site in China.
Trial summary
To assess the efficacy and safety of sunvozertinib as neoadjuvant therapy in patients with stage II-IIIB non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Potentially Resectable EGFR Exon 20 Insertion Non-Small Cell Lung Cancer, Non Small Cell Lung Cancer
- What is being tested?
- Sunvozertinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2024to 1 May 2030
- 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
- 1. The patient must understand the trial requirements and contents, and provide written informed consent.
- 2.Age ≥ 18 years. 3.Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC). Assessed as resectable Stage II-III disease (per the American Joint Committee on Cancer (AJCC) 8th edition).
- 4.Confirmed EGFR exon 20 insertion mutation by a validated test. 5.No evidence of disease progression within the past two weeks prior to signing informed consent and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- 6.Adequate hematological and organ function, as defined by: 7.Hematological: Absolute Neutrophil Count (ANC) ≥ 1.5 × 10^9/L Platelet count ≥ 100 × 10^9/L Hemoglobin ≥ 9 g/dL
- Hepatic:
- Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN); for patients with Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases, total bilirubin ≤ 3 × ULN.
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- Alanine Aminotransferase (ALT) ≤ 2.5 × ULN and Aspartate Aminotransferase (AST) ≤ 2.5 × ULN in the absence of liver metastases; or ALT and AST ≤ 5 × ULN for patients with liver metastases.
- Renal:
- Serum creatinine ≤ 1.5 × ULN, AND Calculated or measured creatinine clearance ≥ 60 mL/min (using the Cockcroft-Gault formula).
- 8.Male patients with female partners of childbearing potential must agree to use a highly effective barrier method of contraception (e.g., condom) during the trial intervention period and for 6 months after the last dose. Male patients must refrain from donating sperm during this same period.
- 9.Female patients must agree to use contraception from the time of screening until 6 weeks after the last dose, must not be breastfeeding, and must have a negative pregnancy test (serum or urine beta-human chorionic gonadotropin, β-hCG) at screening.
Who cannot join
- 1.Prior systemic anti-tumor therapy, including chemotherapy, targeted therapy, immunotherapy, and investigational agents from other clinical trials.
- 2.History of other malignancies within the past 2 years (except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix).
- 3.History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
- 4.Severe or uncontrolled systemic diseases/active infection. 5.Any severe or poorly controlled systemic disease, in the investigator's judgment, including but not limited to the following cardiac conditions or abnormalities: QT interval corrected using Fridericia's formula (QTcF) > 470 msec at rest on electrocardiogram (ECG).
- Any clinically significant abnormalities in cardiac rhythm, conduction, or morphology at rest on ECG, such as complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, PR interval > 250 msec.
- Any factors that increase the risk of QTc prolongation or arrhythmic events, such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death in a first-degree relative under 40 years of age, or any other known condition associated with prolonged QT interval.
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- Presence of atrial fibrillation (except for drug-induced atrial fibrillation which has resolved after discontinuation of the causative agent).
- Myocardial infarction ≤ 6 months prior to the first dose, New York Heart Association (NYHA) Class II or higher congestive heart failure, or poorly controlled arrhythmia despite medical treatment.
- 6.History of interstitial lung disease (ILD), drug-induced ILD, or any evidence of ILD on imaging at screening.
- 7.Refractory nausea and vomiting, chronic gastrointestinal diseases, or significant bowel resection that would preclude adequate absorption of Sunvozertinib.
- 8.Women who are breastfeeding or pregnant. 9.Known hypersensitivity to the active ingredient or any excipients of Sunvozertinib.
- 10.Patients who, in the judgment of the investigator, are unsuitable for participation in this clinical trial or are unlikely to comply with the study procedures and requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Single-arm, Single-center Study of Neoadjuvant Sunvozertinib for Stage II-IIIB Non-small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations.
To assess the efficacy and safety of sunvozertinib as neoadjuvant therapy in patients with stage II-IIIB non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins).
- Conditions
- Potentially Resectable EGFR Exon 20 Insertion Non-Small Cell Lung Cancer, Non Small Cell Lung Cancer
- Being tested
- Sunvozertinib
- Keywords
- Non-small Cell Lung Cancer stage II-IIIB, Sunvozertinib, EGFR Exon 20 insertion, neoadjuvant
- 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.
SunvozertinibDrug
Participants will receive oral administration of sunvozertinib 300 mg QD, with each treatment cycle defined as 28 days, until meeting any treatment discontinuation criteria.
| Study group | Role | What they receive |
|---|---|---|
| Sunvozertinib 300 mg orally, once daily | Experimental | Not described Receives: Drug: Sunvozertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
ORR is defined according to the RECIST v1.1 criteria.
Measured: up to 30 months
Secondary outcomes (8)
Major pathologic response (MPR) rate
Measured: Up to 30 months
Pathological complete response (pCR) rate
Measured: Up to 30 months
Event-free suvival (EFS)
Measured: Up to 60 months
Overall suvival (OS)
Measured: Up to 60 months
R0 resection rate
Measured: Up to 30 months
N2 downstaging rate after neoadjuvant treatment
Measured: Up to 30 months
Treatment-related adverse event (TRAE)
Measured: Up to 30 months
Incidence of treatment discontinuation due to AE/SAE
Measured: Up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start17 Oct 2024
- Primary completion1 May 2030 (estimated)
- Study completion1 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Potentially Resectable EGFR Exon 20 Insertion Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Zhang, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274761
- Sponsor's protocol ID
- LungMate-035
- Status last verified
- Nov 2025
- First submitted
- 28 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The researchers will consider whether IPD is available to other researchers only after the paper is published.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single-arm, Single-center Study of Neoadjuvant Sunvozertinib for Stage II-IIIB Non-small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations.
- ClinicalTrials.gov ID
- NCT07274761
- Acronym / sponsor ID
- LungMate-035
- Conditions
- Potentially Resectable EGFR Exon 20 Insertion Non-Small Cell Lung Cancer, Non Small Cell Lung Cancer
- Keywords
- Non-small Cell Lung Cancer stage II-IIIB, Sunvozertinib, EGFR Exon 20 insertion, neoadjuvant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 1 May 2030 (estimated)
- Study completion
- 1 May 2030 (estimated)
- First posted
- 10 Dec 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.
To assess the efficacy and safety of sunvozertinib as neoadjuvant therapy in patients with stage II-IIIB non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sunvozertinib 300 mg orally, once daily | Experimental | Drug: Sunvozertinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1. The patient must understand the trial requirements and contents, and provide written informed consent.
- 2.Age ≥ 18 years. 3.Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC). Assessed as resectable Stage II-III disease (per the American Joint Committee on Cancer (AJCC) 8th edition).
- 4.Confirmed EGFR exon 20 insertion mutation by a validated test. 5.No evidence of disease progression within the past two weeks prior to signing informed consent and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- 6.Adequate hematological and organ function, as defined by: 7.Hematological: Absolute Neutrophil Count (ANC) ≥ 1.5 × 10^9/L Platelet count ≥ 100 × 10^9/L Hemoglobin ≥ 9 g/dL
- Total bilirubin ≤ 1.5 × Upper Limit of Normal (ULN); for patients with Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases, total bilirubin ≤ 3 × ULN.
Key exclusion criteria (12 listed)
- 1.Prior systemic anti-tumor therapy, including chemotherapy, targeted therapy, immunotherapy, and investigational agents from other clinical trials.
- 2.History of other malignancies within the past 2 years (except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix).
- 3.History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
- 4.Severe or uncontrolled systemic diseases/active infection. 5.Any severe or poorly controlled systemic disease, in the investigator's judgment, including but not limited to the following cardiac conditions or abnormalities: QT interval corrected using Fridericia's formula (QTcF) > 470 msec at rest on electrocardiogram (ECG).
- Any clinically significant abnormalities in cardiac rhythm, conduction, or morphology at rest on ECG, such as complete left bundle branch block, third-degree atrioventricular block, second-degree atrioventricular block, PR interval > 250 msec.
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 |
|---|---|---|
| SunvozertinibParticipants will receive oral administration of sunvozertinib 300 mg QD, with each treatment cycle defined as 28 days, until meeting any treatment discontinuation criteria. | Drug | Sunvozertinib 300 mg orally, once daily |
Primary outcome
Objective response rate (ORR)
Time frame: up to 30 months
ORR is defined according to the RECIST v1.1 criteria.
8 secondary outcomes
Major pathologic response (MPR) rate
Time frame: Up to 30 months
Pathological complete response (pCR) rate
Time frame: Up to 30 months
Event-free suvival (EFS)
Time frame: Up to 60 months
Overall suvival (OS)
Time frame: Up to 60 months
R0 resection rate
Time frame: Up to 30 months
N2 downstaging rate after neoadjuvant treatment
Time frame: Up to 30 months
Treatment-related adverse event (TRAE)
Time frame: Up to 30 months
Incidence of treatment discontinuation due to AE/SAE
Time frame: Up to 30 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 10 Dec 2025.
- Individual participant dataSharing planned: Undecided. The researchers will consider whether IPD is available to other researchers only after the paper is published.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Potentially Resectable EGFR Exon 20 Insertion Non-Small Cell Lung Cancer and Non Small Cell Lung Cancer, run by Shanghai Pulmonary Hospital, Shanghai, China 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 11 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 10 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: up to 30 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 10 Dec 2025.