Trial · NCT07402343
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 | Intracranial overall response rate (ORR) | Up to 36 months | Brain metastases ORR is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) based on central and local investigator's assessment according to RANO-BM criteria on brain MRI |
| Secondary | Brain metastases (BM) disease control rate (DCR) | Up to 36 months | DCR is defined as the proportion of participants with Best Overall Response (BOR) of Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Non-CR/Non-PD according to RANO-BM on brain MRI |
| Secondary | Median CNS PFS | Up to 36 months | According to RANO-BM on brain MRI |
| Secondary | Extracranial ORR | Up to 36 months | Extracranial ORR is evaluated according to RECIST 1.1, measured with CT. ORR is defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR) based on local investigator's assessment |
| Secondary | Extracranial DCR | Up to 36 months | Extracranial DCR is evaluated according to RECIST 1.1, measured with CT. DCR is defined as the proportion of participants with Best Overall Response (BOR) of CR, PR, Stable Disease (SD) or Non-CR/Non-PD. |
| Secondary | Extracranial PFS | Up to 36 months | Extracranial progression free survival (PFS) will be assessed according to RECIST 1.1 based on CT. PFS is the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. |
| Secondary | Overall PFS | Up to 36 months | Overall progression free survival (PFS) is evaluated according to RECIST 1.1 based on CT for extracranial lesions, and RANO-BM based on MRI for BM. |
| Secondary | Overall survival | Up to 48 months | Overall survival (OS) is defined as the time from date of start of treatment to date of death due to any cause |
| Secondary | Number of patients experiencing adverse events according to CTCAE and ASTCT criteria | Up to 36 months | Number of patients experiencing adverse events, according to ASTCT 2019 criteria for immuno effector cell-associated neurotoxicity syndrome (ICANS) and cytokine release syndrome (CRS), and according to CTCAE v5.0 for other adverse events. |
| Other | Efficacy of tarlatamab (survival) in relation to previous cranial radiotherapy | Up to 36 months | Exploratory endpoint: comparison of the efficacy of tarlatamab in patients who previously received cranial radiotherapy to the efficacy in those who were not previously treated with cranial radiotherapy |
| Other | Safety of tarlatamab (adverse events) in relation to previous cranial radiotherapy | Up to 36 months | Exploratory endpoint: comparison of the safety of tarlatamab in patients who previously received cranial radiotherapy to the safety of tarlatamab in those who were not previously treated with cranial radiotherapy |
| Other | Efficacy of tarlatamab in relation to concomitant steroid use | Up to 36 months | Exploratory endpoint: comparison of the efficacy of tarlatamab in patients who concomitantly used steroids to the efficacy in those who were not concomitant steroid users. |
| Other | Safety of tarlatamab (i.e. adverse events) in relation to concomitant steroid use | Up to 36 months | Exploratory endpoint: comparison of the safety of tarlatamab in patients who concomitantly used steroids to the safety in those who were not concomitant steroid users. |
| Other | Evaluate immune environment in cerebrospinal fluid (with lumbar puncture) versus peripheral blood in relation to SCLC responses | Up to 36 months | Exploratory endpoint: tumor response (BM and extracranial response, such as progressive disease, stable disease or (partial) response) in relation to baseline and 12 week evaluation of immune cells in liquor and peripheral blood, respectively. Lumbar puncture not mandatory |
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/NCT07402343/registered