Trial · NCT06676917
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Intracranial Objective Response Rate (ORR-IC) | From date of inclusion until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed through study completion, an average of 8 months. | To assess the efficacy in terms of ORR-IC, defined as the rate of patients with complete response (CR) or partial response (PR) for intracranial (IC) lesions, determined locally by investigator, according to Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria. |
| Secondary | Extracranial Objective Response Rate (ORR-EC) and overall lesions (bicompartmental ORR) | From date of inclusion until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed through study completion, an average of 8 months. | To assess the ORR-EC defined as the rate of patients with objective response (CR or PR) in EC lesions and overall lesions, as determined locally by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v.1.1). |
| Secondary | Progression-Free survival (PFS) for IC lesions | From date of inclusion until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed through study completion, an average of 8 months. | To assess the PFS defined as the period from treatment initiation to the first occurrence of disease progression or death from any cause, whichever occurs first, as per RANO-BM for IC lesions and as per RECIST v1.1 for EC and overall lesions. |
| Secondary | Clinical Benefit Rate (CBR) for IC lesions | From date of inclusion until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed through study completion, an average of 8 months. | To assess the CBR for IC lesions defined as the rate of patients with objective response (CR or PR), or stable disease for at least 24 weeks, as determined locally by the investigator using RANO-BM for IC lesions and using RECIST v1.1 for EC and overall lesions. |
| Secondary | Disease Control Rate (DCR) for IC lesions | From date of inclusion until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed through study completion, an average of 8 months. | To assess the DCR defined as the percentage of patients with advanced cancer whose therapeutic intervention has led to a complete response, partial response, or stable disease as per RANO-BM for IC lesions and as per RECIST v.1.1 for EC and overall lesions. |
| Secondary | Time To Response (TTR) for IC lesions | From date of inclusion until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed through study completion, an average of 8 months. | To assess the TTR for IC lesions defined as the period from the treatment initiation to time of the first objective tumor response (tumor shrinkage of ≥ 30%) observed for patients who achieved a CR or PR, as per RANO-BM for IC lesions and as per RECIST v.1.1 for EC and overall lesions. |
| Secondary | Duration of Response (DoR) for EC and overall lesions | From date of inclusion until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed through study completion, an average of 8 months. | To assess the DoR for EC defined as the period from the first occurrence of a documented objective response to disease progression or death from any cause, observed for patients who achieved a CR or PR, as per RECIST v.1.1. |
| Secondary | Best percentage of change in tumor burden | From date of inclusion until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed through study completion, an average of 8 months. | To evaluate the best percentage of change in tumor burden determined locally by the investigator using RANO-BM for intracranial lesions and RECIST v.1.1 for extracranial and overall measurable lesions (bicompartmental ORR). |
| Secondary | Overall Survival (OS) | From date of inclusion until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed through study completion, an average of 8 months. | To assess the overall survival (OS) defined as the period from treatment initiation to death from any cause, determined locally by the investigator. |
| Secondary | Incidence of Dato-DXd-Emergent Adverse Events (Safety and tolerability) | Through study completion, an average of 8 months. | To determine the safety and tolerability profile of Dato-DXd in NSCLC patients with active Brain Metastases (BMs) according to the NCI-CTCAE v.5.0. |
| Secondary | Quality of Life (QoL) | From date of inclusion until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed through study completion, an average of 8 months. | To evaluate the QoL after Dato-DXd in NSCLC patients with BMs using the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ-C30) |
| Secondary | Neurocognitive Function Questionnaire | From date of inclusion until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed through study completion, an average of 8 months. | To evaluate the neurocognitive function after Dato-DXd in NSCLC patients with BMs using the brain cancer specific questionnaire (QLQ-BN20). |
| Secondary | Neurologic function | From date of inclusion until the date of first documented progression or date of death from any cause or treatment discontinuation from any other reason, whichever came first, assessed through study completion, an average of 8 months. | To evaluate the neurologic function after Dato-DXd in NSCLC patients with BMs using the Neurologic Assessment in Neuro-Oncology (NANO) scale. |
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/NCT06676917/registered