Trial · NCT04603807
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free survival (PFS) in participants with central nervous system (CNS) metastases at baseline | Up to 7 years | PFS is defined as the time from randomization to the first documented disease progression (extracranial or intracranial) or death from any cause whichever occurs first determined by a blinded independent review committee (BIRC) using Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). |
| Secondary | Progression-free survival in the Central Nervous System (CNS-PFS) | Up to 7 Years | CNS-PFS is defined as the time from randomization to the first documented disease progression in the CNS or death from any cause, whichever occurs first, as determined by the BIRC using RECIST v1.1 |
| Secondary | Overall response rate (ORR) | Up to 7 Years | ORR is defined as the percentage of participants who attain Complete Response (CR) or Partial Response (PR) as assessed by the BIRC and the investigator per RECIST v1.1 |
| Secondary | Duration of response (DOR) | Up to 7 Years | DOR is defined as the time from when response (CR or PR) is first documented to disease progression or death, whichever occurs first, as assessed by the BIRC and the investigator per RECIST v1.1 |
| Secondary | Progression-free survival (PFS) | Up to 7 years | PFS is defined as the time from randomization to the first documented disease progression (extracranial or intracranial) or death from any cause, whichever occurs first, as determined by the BICR and investigator using RECIST v1.1 |
| Secondary | Overall survival (OS) | Up to 7 Years | OS is defined as the time from randomization to death from any cause |
| Secondary | Percentage of participants with confirmed deterioration as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) | Up to 7 Years | |
| Secondary | Percentage of participants with impact on lung cancer-specific symptoms assessed by the EORTC QLQ-LC13 | Up to 7 Years | |
| Secondary | Objective response rate in the CNS-ORR in participants with CNS metastases at baseline | Up to 7 Years | CNS-ORR is defined as the percentage of participants who attain CR or PR for lesions in the CNS, as determined by the BIRC per RECIST v1.1 |
| Secondary | Duration of response in the CNS (CNS-DOR) in participants with CNS metastases at baseline | Up to 7 Years | CNS-DOR is defined as the time from when a CNS response (CR or PR) is first documented to disease progression in the CNS, as determined by the BIRC per RECIST v1.1 |
| Secondary | Percentage of participants with Adverse Events and Serious Adverse Events and Adverse Events leading to dose modifications/interruptions, study drug withdrawal or death | Up to 7 Years | Assessed by the investigator according to the NCI CTCAE v5.0 |
| Other | Change in the scores of EuroQol 5-Dimension Questionnaire, 5-level version (EQ-5D-5L) | Up to 7 Years | To evaluate health status utility scores of participants to inform pharmacoeconomic modeling using the EuroQol 5-Dimension Questionnaire (5-level version; EQ-5D-5L) index-based and visual analog scale (VAS) scores |
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/NCT04603807/registered