Trial · NCT07908537
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) | Up to approximately 59 months | PFS is defined as the time from randomization to the first documented progressive disease (PD) as assessed by Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) or death due to any cause, whichever occurs first. PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by blinded independent central review will be reported. |
| Secondary | Overall Survival (OS) | Up to approximately 87 months | OS is defined as the time from randomization to death due to any cause. OS for participants will be reported. |
| Secondary | Distant Metastasis-Free Survival (DMFS) | Up to approximately 87 months | DMFS is defined as the time from randomization to the first documented distant metastasis or death due to any cause, whichever occurs first. Distant metastasis refers to cancer that has spread from the original (primary) tumor and beyond local tissues and lymph nodes to distant organs or distant lymph nodes. DMFS as assessed by investigator will be reported. |
| Secondary | Number of Participants Who Experience One or More Adverse Events (AEs) | Up to approximately 87 months | An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported. |
| Secondary | Number of Participants Who Discontinue Study Intervention Due to an AE | Up to approximately 87 months | An AE is defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported. |
| Secondary | Mean Change From Baseline in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 Item (EORTC QLQ-LC13) Cough (Items 31 and 32) Symptom Scale Score | Baseline and up to approximately 87 months | The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). Participants respond to the question (Item 31) "Have you coughed?" and the question (Item 32) "Have you coughed up blood?" using a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower scale score indicates a better outcome. The mean change from baseline in cough (EORTC QLQ-LC13 Items 31 and 32) scale score will be reported. |
| Secondary | Mean Change From Baseline in EORTC QLQ-LC13 Chest Pain (Item 40) Symptom Scale Score | Baseline and up to approximately 87 months | The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participants respond to the question (Item 40) "Have you had pain in your chest?" using a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower scale score indicates a better outcome. The mean change from baseline in chest pain (EORTC QLQ-LC13 Item 40) scale score will be reported. |
| Secondary | Mean Change From Baseline in EORTC QLQ-LC13 Dyspnea (Items 33, 34, and 35) Symptom Scale Score | Baseline and up to approximately 87 months | The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participants respond to the question (Item 33) "Were you short of breath when you rested?", the question (Item 34) "Were you short of breath when you walked?", and the question (Item 35) "Were you short of breath when you climbed stairs?" using a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower scale score indicates a better outcome. The mean change from baseline in dyspnea (EORTC QLQ-LC13 Items 33, 34, and 35) scale score will be reported. |
| Secondary | Time to Deterioration (TTD) in EORTC QLQ-LC13 Cough (Items 31 and 32) Symptom Scale Score | Baseline and up to approximately 87 months | EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participants respond to the question (Item 31) "Have you coughed?" and the question (Item 32) "Have you coughed up blood?" using a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw symptom scale scores are standardized, so that symptom scale scores range from 0-100. A lower symptom scale score indicates a better outcome. TTD is defined as the time from baseline to first onset of ≥10-point deterioration (increase) in cough (Items 31 and 32), with confirmation at the subsequent visit of ≥10-point deterioration from baseline. A longer TTD indicates a better outcome. TTD in the symptom scale score for EORTC QLQ-LC13 (Items 31 and 32) will be reported. |
| Secondary | TTD in EORTC QLQ-LC13 Chest Pain (Item 40) Symptom Scale Score | Baseline and up to approximately 87 months | EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participants respond to the question (Item 40) "Have you had pain in your chest?" using a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw symptom scale scores are standardized, so that symptom scale scores range from 0-100. A lower symptom scale score indicates a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point deterioration (increase) in chest pain (Item 40), with confirmation at the subsequent visit of ≥10-point deterioration from baseline. A longer TTD indicates a better outcome. TTD in the symptom scale score for EORTC QLQ-LC13 (Item 40) will be reported. |
| Secondary | TTD in EORTC QLQ-LC13 Dyspnea (Items 33, 34, and 35) Symptom Scale Score | Baseline and up to approximately 87 months | EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participants respond to the question (Item 33) "Were you short of breath when you rested?", the question (Item 34) "Were you short of breath when you walked?", and the question (Item 35) "Were you short of breath when you climbed stairs?" using a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw symptom scale scores are standardized, so that symptom scale scores range from 0-100. A lower symptom scale score indicates a better outcome. TTD was defined as the time from baseline to first onset of ≥10-point deterioration (increase) in dyspnea (Items 33, 34, and 35), with confirmation at the subsequent visit of ≥10-point deterioration from baseline. A longer TTD indicates a better outcome. TTD in the symptom scale score for EORTC QLQ-LC13 (Items 33, 34, and 35) will be reported. |
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
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GET https://conductscience.org/api/trials/v1/NCT07908537/registered