Trial · NCT07880353
Real-World Outcomes of Sevabertinib in HER2-Mutant Advanced NSCLC: A Bidirectional Cohort Study
NCT07880353, Recruiting, Ruijin Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Real-World Outcomes of Sevabertinib in HER2-Mutant Advanced NSCLC: A Bidirectional Cohort Study. Trials, record NCT07880353. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07880353
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Real-World Outcomes of Sevabertinib in HER2-Mutant Advanced NSCLC: A Bidirectional Cohort Study
- NCT number
- NCT07880353
- Status
- Recruiting
- Enrollment
- 16 participants, estimated
- Lead sponsor
- Ruijin Hospital
- Conditions
- HER2-mutant Advanced Non-Small Cell Lung Cancer
- Interventions
- Sevabertinib
- First posted
- 2026-10-19
- Last updated
- 2026-11-05
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Real-World Progression-Free Survival (rwPFS) | From the first dose of sevabertinib until the first documented disease progression or death from any cause, whichever occurs first, assessed up to 12 months. | rwPFS is defined as the time from the first dose of sevabertinib to the first documented disease progression or death from any cause, whichever occurs first. |
| Secondary | Investigator-Assessed Real-World Objective Response Rate (rwORR) | From the first dose of sevabertinib through the last available tumor response assessment, up to 12 months. | rwORR is defined as the proportion of evaluable participants whose best overall response is complete response (CR) or partial response (PR), as assessed by the investigator according to RECIST version 1.1. |
| Secondary | Investigator-Assessed Real-World Disease Control Rate (rwDCR) | From the first dose of sevabertinib through the last available tumor response assessment, up to 12 months. | rwDCR is defined as the proportion of evaluable participants who achieve CR, PR, or stable disease (SD). Confirmed and unconfirmed best overall responses will be analyzed separately. |
| Secondary | 6-Month and 12-Month Progression-Free Survival Rates | At 6 months and 12 months after the first dose of sevabertinib. | The probabilities of participants being alive and free from disease progression at 6 months and 12 months after the first dose of sevabertinib. |
| Secondary | Incidence of Treatment-Related Adverse Events | From the first dose of sevabertinib through the last available safety assessment, up to 12 months. | The incidence of treatment-related adverse events of any grade and Grade 3 or higher will be assessed. Adverse events will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 6.0. |
| Secondary | Change From Baseline in EORTC QLQ-C30 Scores | Baseline and at follow-up assessments through 12 months after the first dose of sevabertinib. | The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) assesses cancer-related quality of life. Scores for each scale range from 0 to 100. Higher functional and global health status/quality-of-life scores indicate better functioning or quality of life, whereas higher symptom scores indicate worse symptoms. |
| Secondary | Change From Baseline in NSCLC-SAQ Total Score | Baseline and at follow-up assessments through 12 months after the first dose of sevabertinib. | The Non-Small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ) assesses NSCLC-related symptoms. The total score ranges from 0 to 20, with higher scores indicating greater symptom severity. |
| Secondary | Change From Baseline in EQ-5D-5L Index Score | Baseline and at follow-up assessments through 12 months after the first dose of sevabertinib. | The EuroQol 5-Dimension 5-Level (EQ-5D-5L) assesses overall health status across five dimensions. Using the Chinese value set, index scores range from -0.391 to 1.000, with higher scores indicating better health status. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07880353
GET https://conductscience.org/api/trials/v1/NCT07880353/registered