Trial · NCT07099898
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 24
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) | Up to approximately 113 weeks | OS is defined as the time from the date of randomization to the date of death by any cause |
| Secondary | Brain PFS | Up to approximately 139 weeks | Brain PFS is defined as the time from the date of randomization to the date of first documented PD per modified Response assessment in neuro-oncology (RANO-BM) by BICR assessment or death from any cause, whichever occurs first in participants with history of brain metastasis or presence of brain metastasis at baseline |
| Secondary | Change from baseline in cough | Up to approximately 18 weeks | Validated questionnaires will be used for the assessment |
| Secondary | Change from baseline in dyspnea | Up to approximately 18 weeks | Validated questionnaires will be used for the assessment |
| Secondary | Change from baseline in chest pain | Up to approximately 18 weeks | Validated questionnaires will be used for the assessment |
| Secondary | Time to clinical deterioration in physical functioning | Up to approximately 139 weeks | Time to clinical deterioration in physical functioning will be measured using validated questionnaires |
| Secondary | Objective Response Rate (ORR) | Up to approximately 139 weeks | ORR is defined as the percentage of participants with a confirmed complete (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator/Blinded Independent Central Review (BICR) assessment |
| Secondary | Duration of Response (DoR) | Up to approximately 139 weeks | DoR is defined as the time from the date of first documented objective response (CR or PR) per RECIST 1.1 by investigator/BICR assessment to the date of first documented PD per RECIST 1.1 by investigator/BICR assessment or death due to any cause, whichever comes first |
| Secondary | Progression-free survival (PFS) | Up to approximately 139 weeks | PFS is defined as the time from the date of randomization to the date of first documented Progressive disease (PD) per RECIST 1.1 by investigator/BICR assessment or death from any cause, whichever occurs first |
| Secondary | Disease control rate (DCR) 12 | Up to approximately 11 weeks | DCR12 is defined as the percentage of participants who have a Best objective response (BOR) of confirmed CR, confirmed PR, or Stable Disease (SD) for a duration of at least 11 weeks, per RECIST 1.1 by investigator/BICR assessment |
| Secondary | Brain DoR | Up to approximately 139 weeks | Brain DoR is defined as the time from the first documented objective response (CR/PR according to modified RANO-BM BICR assessment) until the time of first documentation of disease progression or death, whichever occurs first, in participants with a history of brain metastasis or presence of brain metastasis at baseline |
| Secondary | Brain ORR | Up to approximately 139 weeks | Brain ORR is defined as the percentage of participants with confirmed brain CR or confirmed brain PR per modified RANO-BM BICR assessment in participants with a history of brain metastasis or presence of brain metastasis at baseline |
| Secondary | Brain DCR12 | Up to approximately 11 weeks | Brain DCR12 is defined as the percentage of participants with an intracranial BOR of confirmed CR, confirmed PR or SD after the date of randomization, per modified RANO-BM BICR assessment in participants with a history of brain metastasis or presence of brain metastasis at baseline |
| Secondary | Time to brain progression | Up to approximately 139 weeks | Time to brain progression is defined as the time from the date of randomization to the date of first documented brain PD per modified RANO-BM BICR assessment in participants with a history of brain metastasis or presence of brain metastasis at baseline. |
| Secondary | Number of participants with Adverse events (AEs), Serious Adverse Events (SAEs) and Adverse events of special interest (AESIs) by severity | Up to approximately 139 weeks | |
| Secondary | Number of participants with AEs leading to dose modifications or study intervention discontinuation | Up to approximately 139 weeks | |
| Secondary | Number of participants with a change from baseline in vital signs | Baseline (Day -1) and up to approximately 139 weeks | Number of participants will be assessed. |
| Secondary | Number of participants with a change from baseline in laboratory parameters (hematology and clinical chemistry) | Baseline (Day -1) and up to approximately 139 weeks | Number of participants will be assessed. |
| Secondary | Number of participants with a change from baseline in cardiac function [Electrocardiogram (ECG) | Baseline (Day -1) and up to approximately 139 weeks | Number of participants will be assessed. |
| Secondary | Number of participants with a change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status | Baseline (Day -1) and up to approximately 139 weeks | Number of participants will be assessed. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT07099898/registered