Trial · NCT07361484
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 | Overall Survival (OS) | Approximately 2 years after study initiation. | OS is defined as the time from randomization to death from any cause |
| Secondary | Progression-Free Survival (PFS) | Approximately 2 years after study initiation. | Time from randomization to the first documentation of disease progression per RECIST v1.1 or death from any cause, whichever occurs first. |
| Secondary | Objective Response Rate (ORR) | Approximately 2 years after study initiation. | Proportion of participants with best overall response of complete response (CR) or partial response (PR) per RECIST v1.1. |
| Secondary | Incidence of Grade 4 Neutropenia (Cycle 1 Day 8 ANC) | At Day 8 of Cycle 1 (approximately 1 week after the first dose; each treatment cycle is 21 days). | Proportion of participants with Grade 4 neutropenia, defined as absolute neutrophil count (ANC) \<0.5 × 10\^9/L, based on ANC on Day 8 of Cycle 1. |
| Secondary | Overall Survival (OS) Rate at Month 24 | 24 months after randomization. | Proportion of participants alive at 24 months after randomization. |
| Secondary | Overall Survival (OS) Rate at Month 36 | 36 months after randomization. | Proportion of participants alive at 36 months after randomization. |
| Secondary | Duration of Response (DoR) | Approximately 2 years after study initiation. | Time from first documented CR or PR (whichever occurs first) until disease progression per RECIST v1.1 or death from any cause. |
| Secondary | Disease Control Rate (DCR) | Approximately 2 years after study initiation. | Proportion of participants with CR, PR, or stable disease (SD) lasting ≥6 months per RECIST v1.1. |
| Secondary | Incidence of New Brain Metastases | Approximately 2 years after study initiation. | Incidence of new brain metastases based on brain imaging (MRI or head CT). |
| Secondary | Quality of Life (QoL) - EORTC QLQ-LC13 | Approximately 2 years after study initiation. | Change from baseline in EORTC QLQ-LC13 scores. Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13). Scores are transformed to a 0 to 100 scale. Higher scores indicate worse symptoms / greater symptom burden (worse outcome). |
| Secondary | Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Approximately 2 years after study initiation. | TEAEs and SAEs will be assessed throughout the study and summarized by frequency, severity (per CTCAE), and relationship to study treatment. |
| Other | Metastasis-Free Survival (MFS) | Approximately 2 years after study initiation. | MFS is defined as the time from randomization to the first occurrence of new distant metastasis or death from any cause, whichever occurs first. |
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/NCT07361484/registered