Non Small Cell Lung CancerNCT06786208
Real-world Study of Sunvozertinib Treatment in Advanced EGFR-Mutant NSCLC After EGFR-TKI Treatment Failure
An observational study of Non Small Cell Lung Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
Observe the efficacy and safety of sunvozertinib in the real world in the treatment of EGFRm aNSCLC patients with previous EGFR-TKI treatment 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
- Type of treatment
- Pill or oral medicine
- How many people
- 55 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2025to 30 Jun 2027
- Phase
- Observational
- 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
Study population: Locally advanced or metastatic NSCLC with EGFR-sensitive mutations who have been previously treated with EGFR-TKIs and PD for last therapy can be involved in this study. Investigators will assess patients whether to be suitable for sunvozertinib treatment.
Who may be able to join
- To provide a signed and dated, written informed consent.
- Age ≥ 18 years old
- Histologically or cytologically confirmed non-squamous NSCLC with documented EGFR mutations from a local laboratory
- EGFR-sensitive mutations including exon 19 deletion and exon 21 L858R mutated，at least one line chemotherapy and progress again
- Predicted life expectancy ≥ 12 weeks
- Adequate organ system function:
- Patient must have measurable disease according to RECIST 1.1. -
Who cannot join
- Spinal cord compression or meningeal metastasis
- Not Recover from AEs caused by previous treatment yet
- A history of stroke or intracranial hemorrhage within 6 months prior to initial dosing.
- Any severe or poorly controlled systemic disease per investigator's judgment .active infections, including but not limited to hepatitis B (HBV), hepatitis C HCV, and human immunodeficiency HIV
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
Qiming Wang
Zhengzhou, Henan, 450000
Qi Ming Wang, Doctor of Oncology, 13783590691 ext. Medical Doctor, qimingwang1006@126.com
About this study
Official title: Real-world Study of Sunvozertinib Treatment in Locally Advanced or Metastatic EGFR-Mutant NSCLC After EGFR-TKI Treatment Failure
Observe the efficacy and safety of sunvozertinib in the real world in the treatment of EGFRm aNSCLC patients with previous EGFR-TKI treatment
Read the detailed description
Locally advanced or metastatic NSCLC with EGFR-sensitive mutations who have been previously treated with EGFR-TKIs and PD for last therapy can be involved in this study. Investigators will assess patients whether to be suitable for sunvozertinib treatment. And this study will evaluate the safety and efficacy.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- Sunvozertinib
- Keywords
- Non Small Cell Lung Cancer, Sunvozertinib, EGFR
- 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
sunvozertinb, a EGFR-TKI, 300mg QD oral
| Study group | Role | What they receive |
|---|---|---|
| sunvozertinib treatment cohort | Patients: locally advanced or metastatic NSCLC with EGFR-sensitive mutations who have been previously treated with EGFR-TKIs and PD for last therapy.
Investigators will assess patients whether to be suitable for sunvozertinib treatment. And this study will evaluate the safety and efficacy. Receives: Drug: Sunvozertinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
assess the proportion of subjects who have a complete response (CR) or a partial response (PR)]
Measured: Time from first dose to last dose, up to 24 month
Secondary outcomes (2)
Progression-free survival (PFS)
To assess anti-tumor activity of Sunvozertinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator
Measured: Time from first dose to first documented disease progression assessed by investigator or death due to any cause up to 24 month
Overall survival (OS)
To assess anti-tumor activity of Sunvozertinib according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator
Measured: Time Frame: Time from first dose to the death of the subject due to any cause assessed up to 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start1 Feb 2025 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 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 Henan Cancer HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786208
- Sponsor's protocol ID
- 2024-388
- Other IDs
- 2024-388
- Status last verified
- Nov 2024
- First submitted
- 15 Jan 2025
- Last updated
- 22 Jan 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 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world Study of Sunvozertinib Treatment in Locally Advanced or Metastatic EGFR-Mutant NSCLC After EGFR-TKI Treatment Failure
- ClinicalTrials.gov ID
- NCT06786208
- Acronym / sponsor ID
- 2024-388
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- Non Small Cell Lung Cancer, Sunvozertinib, EGFR
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 1 Feb 2025 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 22 Jan 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.
Observe the efficacy and safety of sunvozertinib in the real world in the treatment of EGFRm aNSCLC patients with previous EGFR-TKI treatment
Detailed description
Locally advanced or metastatic NSCLC with EGFR-sensitive mutations who have been previously treated with EGFR-TKIs and PD for last therapy can be involved in this study. Investigators will assess patients whether to be suitable for sunvozertinib treatment. And this study will evaluate the safety and efficacy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sunvozertinib treatment cohort | – | Drug: SunvozertinibPatients: locally advanced or metastatic NSCLC with EGFR-sensitive mutations who have been previously treated with EGFR-TKIs and PD for last therapy. Investigators will assess patients whether to be suitable for sunvozertinib treatment. And this study will evaluate the safety and efficacy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Locally advanced or metastatic NSCLC with EGFR-sensitive mutations who have been previously treated with EGFR-TKIs and PD for last therapy can be involved in this study. Investigators will assess patients whether to be suitable for sunvozertinib treatment.
Key inclusion criteria (7 listed)
- To provide a signed and dated, written informed consent.
- Age ≥ 18 years old
- Histologically or cytologically confirmed non-squamous NSCLC with documented EGFR mutations from a local laboratory
- EGFR-sensitive mutations including exon 19 deletion and exon 21 L858R mutated，at least one line chemotherapy and progress again
- Predicted life expectancy ≥ 12 weeks
Key exclusion criteria (4 listed)
- Spinal cord compression or meningeal metastasis
- Not Recover from AEs caused by previous treatment yet
- A history of stroke or intracranial hemorrhage within 6 months prior to initial dosing.
- Any severe or poorly controlled systemic disease per investigator's judgment .active infections, including but not limited to hepatitis B (HBV), hepatitis C HCV, and human immunodeficiency HIV
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 |
|---|---|---|
| Sunvozertinibsunvozertinb, a EGFR-TKI, 300mg QD oral | Drug | sunvozertinib treatment cohort |
Primary outcome
Objective Response Rate (ORR)
Time frame: Time from first dose to last dose, up to 24 month
assess the proportion of subjects who have a complete response (CR) or a partial response (PR)]
2 secondary outcomes
Progression-free survival (PFS)
Time frame: Time from first dose to first documented disease progression assessed by investigator or death due to any cause up to 24 month
Overall survival (OS)
Time frame: Time Frame: Time from first dose to the death of the subject due to any cause assessed up to 36 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 22 Jan 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?
An observational study of Non Small Cell Lung Cancer, run by Henan Cancer Hospital 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 7 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: opening soon, as of the sponsor's last update on 22 Jan 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Time from first dose to last dose, up to 24 month). 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 22 Jan 2025.