Trial · NCT07472517
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 | Overall survival (OS) | Up to 36 months | OS, defined as the time from randomisation until death from any cause |
| Secondary | Progression free survival (PFS) | Up to 36 months | PFS, defined as the time from randomisation until the earliest date of tumour progression according to the Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1 based on investigator assessments or death from any cause |
| Secondary | Change From Baseline in Selected Disease Symptoms Included in the European Organization for Research and Treatment of Lung Cancer Quality of Life Questionnaire (EORTC-QLQ-LC13) | At baseline and up to 1 year | EORTC QLQ-LC13: European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire lung cancer-specific 13-item questionnaire module (QLQ-LC13) includes one multi-item scale (dyspnoea, based on three items) and ten single-item measures capturing symptoms such as coughing, haemoptysis, pain, and treatment-related toxicities including sore mouth, dysphagia, and peripheral neuropathy. All QLQ-LC13 items are scored on a 4-point Likert scale (1 = "not at all," 4 = "very much"). All QLQ-LC13 scores range from 0 to 100, with higher scores indicating greater symptom burden or more severe problems |
| Secondary | Overall response (OR) | Up to 36 months | OR, defined as a best overall response of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 (based on investigator assessments) from the date of randomisation until the earliest date of disease progression, death, last evaluable tumour assessment before start of subsequent anti-cancer therapy, lost to follow-up, or withdrawal of consent |
| Secondary | Occurrence of treatment-emergent Cytokine Release Syndrome (CRS) during the on-treatment period | Up to 36 months | |
| Secondary | Occurrence of treatment-emergent Immune effector cell-associated neurotoxicity syndrome (ICANS) during the on-treatment period | Up to 36 months | |
| Secondary | Occurrence of treatment-emergent adverse events (AEs) leading to trial medication discontinuation during the on-treatment period | Up to 36 months | |
| Secondary | Occurrence of treatment-emergent AEs leading to trial medication dose delay during the on-treatment period | Up to 36 months | |
| Secondary | Occurrence of treatment-emergent AEs leading to trial medication dose reduction during the on-treatment period | Up to 36 months | |
| Secondary | Time to deterioration (TTD), defined as time from randomisation to deterioration maintained for 2 consecutive assessments or 1 assessment followed by death from any cause within 3 weeks | Up to 3 weeks | Assessments are a composite of the following European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ EORTC) scores: * Dyspnea as measured by EORTC-QLQ-C30 and EORTC-QLQ-LC13 * Chest pain as measured by EORTC-QLQ-LC13 * Cough as measured by EORTC-QLQ-LC13 These questionnaires request scores on global health status, functioning, symptoms, as well as single items to assess dyspnoea, insomnia, appetite loss, constipation, diarrhoea and financial difficulties. All scores range from 0 to 100. For scores regarding functioning and global quality of life, higher scores represent better functioning and better quality of life. For scores regarding symptom scales higher scores indicate greater symptom burden. |
| Secondary | Change From Baseline in Symptom Severity as Measured by scales of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-LC13 | At baseline and up to 1 year | EORTC QLQ-LC13: EORTC Quality of Life Questionnaire lung cancer-specific 13-item questionnaire module (QLQ-LC13) includes one multi-item scale (dyspnoea, based on three items) and ten single-item measures capturing symptoms such as coughing, haemoptysis, pain, and treatment-related toxicities including sore mouth, dysphagia, and peripheral neuropathy. All QLQ-LC13 items are scored on a 4-point Likert scale (1 = "not at all," 4 = "very much"). All QLQ-LC13 scores range from 0 to 100, with higher scores indicating greater symptom burden or more severe problems |
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/NCT07472517/registered