Trial · NCT04632758
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival (PFS) | from randomization until firstly recorded disease progression or death (whichever occurs earlier), or to the date that the last patients observed for 12 months | PFS as assessed by independent radiology review based on RECIST v. 1.1 criteria |
| Secondary | Progression-free survival (PFS) | from randomization until firstly recorded disease progression or death (whichever occurs earlier), or to the date that the last patients observed for 12 months | PFS based on investigator assessment |
| Secondary | OS | from randomization until death due to any cause, withdraws informed consent, is lost to follow-up or refuses phone visits, or study completion（up to 2.5 years） | Overall survival (OS) |
| Secondary | Confirmed Objective Response Rate (ORR) Assessed By independent radiology review | From fist administration to the date that the last patients observed for 12 months | ORR is defined the percentage of the participants who have achieved complete response (CR) or partial response (PR) per independent radiology review using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after the initiation of study treatment. |
| Secondary | Confirmed Objective Response Rate (ORR) Assessed By Investigators | From fist administration to the date that the last patients observed for 12 months | ORR is defined the percentage of the participants who have achieved complete response (CR) or partial response (PR) per Investigators using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after the initiation of study treatment. |
| Secondary | Time to Response (TTR) Assessed By independent radiology | From fist administration to the date that the last patients observed for 12 months | Assessed from date of the first dose until the date of progression per independent radiology review |
| Secondary | Time to Response (TTR) Assessed By Investigators | From fist administration to the date that the last patients observed for 12 months | Assessed from date of the first dose until the date of progression per investigator. |
| Secondary | Duration of response (DOR) Assessed By independent radiology | From fist administration to the date that the last patients observed for 12 months | The DOR is defined as the time from the date of the first response CR/PR (whichever is first recorded) to the date on which progressive disease (PD) is first noted or date of death. |
| Secondary | Duration of response (DOR) Assessed By Investigators | From fist administration to the date that the last patients observed for 12 months | The DOR is defined as the time from the date of the first response CR/PR (whichever is first recorded) to the date on which progressive disease (PD) is first noted or date of death. |
| Secondary | CNS response rate based on independent radiology review | From fist administration to the date that the last patients observed for 12 months | CNS response rate based on independent radiology review |
| Secondary | CNS response rate based on investigator assessment | From fist administration to the date that the last patients observed for 12 months | CNS response rate based on investigator assessment |
| Secondary | Time to CNS progression | From fist administration to the date that the last patients observed for 12 months | Time to CNS progression |
| Secondary | Percentage of patients with adverse events | from the signing of the informed consent form until at least 28 days after the last dose of study drug was administered. | the incidence of adverse events, including adverse events (AEs), serious adverse events (SAEs), treatment-emergent adverse events (TEAEs). Causality is determined by the investigator. |
| Secondary | Plasma concentrations (Cssmin) | Cssmin before dosing on Cycle 1 Day 1, Cycle 1 Day 7, Cycle 1 Day 21, Cycle 2 Day 21, and Cycle 4 Day 21 | Minimum value of steady plasma-drug concentration for WX-0593 at participating sites |
| Secondary | Patient reported time to deterioration (TTD) | From fist administration to the date that the last patients observed for 12 months | Patient reported time to deterioration (TTD) as measured by EORTC C30/LC13 QoL questionnaire |
| Secondary | Patient reported time to deterioration (TTD) | From fist administration to the date that the last patients observed for 12 months | Patient reported time to deterioration (TTD) as measured by Lung Cancer Symptom Scale (LCSS) questionnaire |
| Secondary | Patient reported health-related quality of life (HRQoL) | From fist administration to the date that the last patients observed for 12 months | Patient reported health-related quality of life (HRQoL) as measured by EORTC C30/LC13 QoL questionnaire |
| Secondary | Patient reported health-related quality of life (HRQoL) | From fist administration to the date that the last patients observed for 12 months | Patient reported health-related quality of life (HRQoL) as measured by Lung Cancer Symptom Scale (LCSS) questionnaire |
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.
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GET https://conductscience.org/api/trials/v1/NCT04632758/registered