Trial · NCT06712355
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall survival (OS) | Up to approximately 46 months | OS defined as the time from randomization to death from any cause. |
| Secondary | Progression-free survival (PFS) | Up to approximately 46 months | PFS defined as the time from randomization to first objective tumor progression (progressive disease per Response Evaluation Criteria in Solid Tumors version 1.1 \[RECIST v1.1\]), or death from any cause, whichever occurs first. |
| Secondary | Objective response rate (ORR) | Up to approximately 46 months | ORR defined as the proportion of participants in whom a complete response (CR) or partial response (PR) (based on investigator's assessment per RECIST v1.1) is observed as best overall response with confirmation. |
| Secondary | Duration of response (DOR) | Up to approximately 46 months | DOR defined as the time from onset of objective response (confirmed CR or PR based on investigator's assessment per RECIST v1.1) to first occurrence of objective tumor progression (progressive disease per RECIST v1.1) or death from any cause, whichever occurs first. |
| Secondary | PFS rate based on investigator's assessment | At 6, 12, and 18 months | |
| Secondary | OS rate | At 6, 12, 18, and 24 months | |
| Secondary | Occurrence of treatment-emergent adverse events (TEAEs) including Grade ≥3, serious, and fatal TEAEs by relationship | From the first dose of study treatment to the 90-Day Follow-up Visit | TEAEs graded according to (US) National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 |
| Secondary | Occurrence of dose delay, infusion interruption and discontinuation of study treatment due to TEAEs (including related TEAEs) | From first to last dose of study treatment, i.e., up to 2 years | |
| Secondary | Change from baseline in European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-Life Core 30 questionnaire (QLQ-C30) Global Health status/Quality-of-Life score (Items 29 and 30) | Up to approximately 46 months | Global health status/QoL scale ranges in score from 0 to 100 with a high scale score representing a higher response level (e.g., high score for global health status/QoL is high QoL: high score for symptom scale/item is high symptomatology or problems). |
| Secondary | Change from baseline in EORTC QLQ-C30 physical functioning | Up to approximately 46 months | Physical functioning scale ranges in score from 0 to 100 with a high scale score representing a higher response level (e.g., high score for functional scale is high/healthy level of functioning). |
| Secondary | Change from baseline in coughing scale of the EORTC Quality-of-Life-Lung cancer 29 questionnaire (QLQ-LC29) | Up to approximately 46 months | Multi-item coughing scale ranges in score from 0 to 100 with a high score representing a high level of symptomatology or problems. |
| Secondary | Change from baseline in shortness of breath scale of the EORTC QLQ-LC29 | Up to approximately 46 months | Multi-item shortness of breath scale ranges in score from 0 to 100 with a high score representing a high level of symptomatology or problems. |
| Secondary | Change from baseline in coughed up blood item of the EORTC QLQ-LC29 | Up to approximately 46 months | Single item coughing up blood ranges in score from 0 to 100 with a high score representing a high level of symptomatology or problems. |
| Secondary | Change from baseline in Functional Assessment of Cancer Therapy-General overall bother item (FACT-GP5). | Up to approximately 46 months | The FACT-G - Item GP5 (Version 4) is a single-item summary measure of the overall impact of treatment toxicity, based upon its association with the number and degree of AEs in clinical studies, rated on a 5-point Likert scale ("not at all" to "very much") with a recall period of past 7 days. A high score represents high level of 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/NCT06712355/registered