Trial · NCT07566052
Registered outcomes30
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 30
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. as assessed by blinded independent central review (BICR) | Up to 2.3 years | PFS is defined as the time from the date of randomization until the date of documented radiographic disease progression per RECIST v1.1, as assessed by BICR or until death due to any cause, whichever comes first. |
| Primary | Overall Survival (OS) | Up to 4.2 years | OS is defined as the time from the date of randomization until the date of death from any cause. |
| Secondary | Time to deterioration in NSCLC symptoms (TDLCS): cough evaluated via European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) items | Up to 2.3 years | TDLCS: cough is defined as time between randomization and the first occurrence of a meaningful deterioration in the corresponding EORTC QLQ-LC13 coughing score (item 31) compared with the baseline score. EORTC QLQ-LC13 is a lung-cancer specific module that serves as an additional 13 item questionnaire to the general EORTC cancer questionnaire. It consists of 3 items to assess dyspnea, and 10 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. Scores range from 0 to 100. A high score for a symptom scale/item represents a high level of symptomatology/problems. |
| Secondary | TDLCS: chest pain evaluated via EORTC QLQ-LC13 | Up to 2.3 years | TDLCS: chest pain is defined as the time between randomization and the first occurrence of a meaningful deterioration in the EORTC QLQ-LC13 chest pain score (item 40) compared with the baseline score. EORTC QLQ-LC13 is a lung-cancer specific module that serves as an additional 13 item questionnaire to the general EORTC cancer questionnaire. It consists of 3 items to assess dyspnea, and 10 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. Scores range from 0 to 100. A high score for a symptom scale/item represents a high level of symptomatology/problems. |
| Secondary | TDLCS: dyspnea evaluated via EORTC QLQ-LC13 | Up to 2.3 years | TDLCS: dyspnea is defined as the time between randomization and the first occurrence of a meaningful deterioration in the EORTC QLQ-LC13 dyspnea score (composite of items 33 to 35) compared with the baseline score. EORTC QLQ-LC13 is a lung-cancer specific module that serves as an additional 13 item questionnaire to the general EORTC cancer questionnaire. It consists of 3 items (items 33 to 35) to assess dyspnea, and 10 single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. Scores range from 0 to 100. A high score for a symptom scale/item represents a high level of symptomatology/problems. |
| Secondary | Time to Worsening of Global Health Status/Quality of Life (GHS/QoL) (TWGQ) measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | Up to 2.3 years | TWGQ is defined as time between randomization and the first occurrence of a meaningful worsening in the composite EORTC QLQ-C30 item scores (19 and 30) compared with the baseline score. EORTC-QLQ-C30 is a 30-item cancer-specific instrument consisting of 5 functional scales (physical, role, emotional, social and cognitive), 9 symptom scales/items (fatigue, nausea/vomiting, general pain, dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties) and a global health status scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." For functional scales, higher scores indicate better functioning, while for symptom scales/items, higher scores indicate worse symptoms. |
| Secondary | Objective Response Rate (ORR) per RECIST v1.1, as assessed by BICR | Up to 2.3 years | ORR is defined as the proportion of participants whose best overall response (BOR) is rated as confirmed complete response (CR) or confirmed partial response (PR) per RECIST v1.1. as assessed by BICR. |
| Secondary | Time to response (TTR) per RECIST v 1.1 as assessed as assessed by BICR | Up to 2.3 years | TTR is defined as the time from the date of randomization to the first documentation of objective response (confirmed CR or confirmed PR) per RECIST v1.1. as assessed by BICR. |
| Secondary | Duration of Response (DOR) per RECIST v 1.1 as assessed by BICR | Up to 2.3 years | DOR is defined as the time from the date of first documented response (CR or PR subsequently confirmed) to the date of first documented PD per RECIST v1.1 assessed by BICR, or death due to any cause, whichever occurs first. |
| Secondary | Disease Control Rate (DCR) per RECIST v 1.1 as assessed by BICR | Up to 2.3 years | DCR is defined as the proportion of participants whose best overall response is rated as CR, confirmed PR or SD per RECIST v1.1 as assessed by BICR. |
| Secondary | PFS per RECIST v1.1. as assessed by the investigator | Up to 2.3 years | PFS is defined as the time from the date of randomization until the date of documented radiographic disease progression per RECIST v1.1 as assessed by the investigator or until death due to any cause, whichever comes first. |
| Secondary | ORR per RECIST v1.1. as assessed by the investigator | Up to 2.3 years | ORR is defined as the proportion of participants whose BOR is rated as confirmed CR or confirmed PR per RECIST v1.1. as assessed by the investigator. |
| Secondary | TTR per RECIST v 1.1 as assessed by the investigator | Up to 2.3 years | TTR is defined as the time from the date of randomization to the first documentation of objective response (confirmed CR or confirmed PR) per RECIST v1.1. as assessed by the investigator. |
| Secondary | DOR per RECIST v 1.1 as assessed by the investigator | Up to 2.3 years | DOR is defined as the time from the date of first documented response (CR or PR subsequently confirmed) to the date of first documented PD per RECIST v1.1 as assessed by the investigator or death due to any cause, whichever occurs first. |
| Secondary | DCR per RECIST v 1.1 as assessed by the investigator | Up to 2.3 years | DCR is defined as the proportion of participants whose best overall response is rated as CR, confirmed PR or SD per RECIST v1.1 as assessed by the investigator. |
| Secondary | Number of Participants with Adverse Events (AEs) | Up to 4.2 years | An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
| Secondary | Number of Participants with Serious Adverse Events (SAEs) | Up to 4.2 years | An SAE is defined as any untoward medical occurrence that, at any dose: Results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and other medically important events. |
| Secondary | Number of Participants with laboratory value abnormalities and/or AEs | Up to 4.2 years | Number of participants with potentially clinically significant laboratory values. |
| Secondary | Number of Participants with electrocardiogram (ECG) abnormalities and/or AEs | Up to 4.2 years | Number of participants with potentially clinically significant ECG values. |
| Secondary | Number of Participants with vital sign abnormalities and/or AEs | Up to 4.2 years | Number of participants with potentially clinically significant vital sign values. |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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.
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