Trial · NCT05204628
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | From the date of randomization to the date of the first documented disease progression or death, whichever occurred first (up to overall period of approximately 30 months) | PFS was defined as the time (in months) from randomization to the first documentation of disease progression, as determined by investigators using Response Evaluation Criteria in Solid Tumor (RECIST) v1.1 or to death from any cause, whichever occurred first. |
| Secondary | Progression-Free Survival (PFS) | From the date of randomization to the date of the first documented disease progression or death, whichever occurred first (up to overall period of approximately 30 months). | PFS was defined as the time (in months) from randomization to the first documentation of disease progression, as Determined by Blind Independent Central Review(BICR)Using RECISTv1.1., or to death from any cause, whichever occurred first. |
| Secondary | Overall Survival (OS) | From randomization until death (up to approximately 30 months). | OS defined as time from date of randomization to date of death due to any cause, as Determined by the investigator and Blind Independent Central Review (BICR) Using RECISTv1.1 |
| Secondary | Overall Response Rate (ORR) | From randomization until death (up to approximately 30 months) | ORR defined as the proportion of patients with a best overall response defined as Complete Response (CR) or Partial Response (PR) as evaluated by Blinded Independent Central Review (BICR) and by investigator assessment per RECIST 1.1 |
| Secondary | Duration of Response (DOR) | From randomization until death (up to approximately 30 months) | DOR defined as the time from date of first documented CR or PR to date of first documented disease progression or death due to any cause |
| Secondary | Disease Control Rate (DCR) | Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study (up to overall period of approximately 30 months) | DCR defined as the proportion of patients with best overall response of CR, PR, or Stable Disease (SD) |
| Secondary | Intracranial Objective Response Rate (IC-ORR) | Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study (up to overall period of approximately 30 months) | IC-ORR as Determined by BICR and investigator Using Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) |
| Secondary | Intracranial Duration of Response (IC-DoR) | Baseline, Week 8, thereafter every 8 weeks until disease progression, death or withdrawal from the study (up to overall period of approximately 30 months) | IC-ORR as Determined by BICR and investigator Using Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) |
| Secondary | Area Under the Plasma Concentration-time Curve (AUC) of XZP-3621 and Its Metabolite | Pre-dose (within 1 hour before XZP-3621), 4 hours post-dose at first dosing day and Week 4; Pre-dose (within 1 hour) at Week 8,12,16 (up to 4 months) | AUC was collected for both XZP-3621 and its major metabolite, and was based on their concentrations in plasma over time. |
| Secondary | Maximum Plasma Concentration Observed (Cmax) of XZP-3621 and Its Metabolite | Pre-dose (within 1 hour before XZP-3621), 4 hours post-dose at first dosing day and Week 4; Pre-dose (within 1 hour) at Week 8,12,16 (up to 4 months) | Cmax was collected for both XZP-3621 and its major metabolite, and was based on their concentrations in plasma over time. |
| Secondary | Time to Deterioration by EORTC Quality of Life Questionnaire Lung Cancer Module 13 (LC13) | Baseline, Week 4, thereafter every 4 weeks until disease progression, death or withdrawal from the study and 2 weeks after permanent discontinuation (up to overall period of approximately 30 months) | The EORTC QLQ-LC13 module generated one multiple-item scale score assessing dyspnea and a series of single item scores assessing chest pain, arm/shoulder pain, pain in other parts, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. All the scales and single-item scores were linearly transformed so that each score ranged from 0 to 100. A higher score on the global health and functioning subscales is indicative of better functioning. Confirmed clinically meaningful deterioration in lung cancer symptoms is defined as a \>or=10-point increase from baseline in a symptom score that must be held for at least two consecutive assessments or an initial \>or=10-point increase above baseline followed by death within 5 weeks from the last assessment. |
| Secondary | Change From Baseline in Global Health Status/Quality of Life as Assessed by EORTC QLQ-C30 | Baseline, Week 4, thereafter every 4 weeks until disease progression, death or withdrawal from the study and 4 weeks after permanent discontinuation (up to overall period of approximately 30 months) | HRQoL: perceived quality of participant's life, includes self-reported multidimensional measures of physical and mental health. Patient-reported symptoms (PROs) and HRQoL will be collected by administering the european organisation for research and treatment of cancer (EORTC) quality of life (QLQ)-C30 questionnaire. EORTC-QLQ-C30 contains 30 items across 5 functional scales (physical, role, cognitive, emotional, and social), 9 symptom scales (fatigue, nausea and vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status/QOL scale. The 30 items have 4 response levels (not at all, a little, quite a bit, and very much), with 2 questions relying on a 7-point numeric rating scale. Raw scores are converted into overall score ranging from 0 to 100, where lower scores indicate better QOL. A negative change from Baseline indicates improvement. |
| Secondary | Percentage of Participants with Non-serious Adverse Events and Serious Adverse Events | Up to overall period of approximately 30 months | Percentage of Participants with Non-serious, Adverse Events and Serious Adverse Events. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product |
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/NCT05204628/registered