Trial · NCT07423585
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 | 6-month progression-free survival (PFS) | From the initiation of investigational therapy to progression, symptomatic deterioration, or death due to any cause, whichever comes first, assessed up to 6 months | Will be evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 or death as a result of any cause. Will be calculated as the proportion of patients who are progression-free and alive divided by the total number of evaluable patients. Exact binomial 95% confidence intervals (CIs) for the 6-month PFS true rate will be calculated. |
| Primary | Rapid progressive disease (PD) on tarlatamab rate probability (Interim analysis for futility monitoring) | Within 4 weeks of starting tarlatamab | Will be measured by RECIST v 1.1. Will be measured by the proportion of patients who have clinical and rapid clinical and radiological progression and move on to receive subsequent standard of care platinum-based chemotherapy and immune checkpoint inhibitors divided by the total number of evaluable patients. Exact binomial 95% CIs for the tarlatamab failure true rate will be calculated. |
| Secondary | Rate of all adverse events (AEs) | Up to 30 days after last dose of study treatment | Will be summarized using National Cancer Institute Common Terminology Criteria for Adverse Events v 5.0. Frequency and severity and tolerability of the regimen will be collected and summarized using descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. The incidence of all and severe (grade 3+) AEs or toxicities will be described. Time to onset and duration will be described. The number of patients who required dose delays and/or treatment discontinuation will be assessed. Will capture the proportion of patients who go off treatment due to adverse reactions or even those who refuse further treatment for lesser toxicities that inhibit their willingness to continue participation on the trial. |
| Secondary | Rate of all cytokine release syndrome | Up to 30 days after last dose of study treatment | Will be measured using American Society for Transplantation and Cellular Therapy (ASTCT). Frequency and severity and tolerability of the regimen will be collected and summarized using descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. The incidence of all and severe (grade 3+) AEs or toxicities will be described. Time to onset and duration will be described. The number of patients who required dose delays and/or treatment discontinuation will be assessed. Will capture the proportion of patients who go off treatment due to adverse reactions or even those who refuse further treatment for lesser toxicities that inhibit their willingness to continue participation on the trial. |
| Secondary | Rate of all immune effector cell associated neurotoxicity syndrome | Up to 30 days after last dose of study treatment | Will be measured using ASTCT. Frequency and severity and tolerability of the regimen will be collected and summarized using descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. The incidence of all and severe (grade 3+) AEs or toxicities will be described. Time to onset and duration will be described. The number of patients who required dose delays and/or treatment discontinuation will be assessed. Will capture the proportion of patients who go off treatment due to adverse reactions or even those who refuse further treatment for lesser toxicities that inhibit their willingness to continue participation on the trial. |
| Secondary | Overall objective response rate (ORR) | Up to 2 years after last dose of study treatment | Will be calculated by the proportion of patients with confirmed complete response (CR) or partial response (PR) using RECIST v 1.1 divided by the total number of evaluable patients. Exact binomial 95% CIs for the true PR + CR response rate will be calculated. |
| Secondary | Duration of response (DOR) | From first occurrence of a documented objective response to the time of disease progression or death from any cause, whichever comes first, assessed up to 2 years after last dose of study treatment | Will be determined using RECIST v 1.1. The Kaplan-Meier method will be used to estimate DOR. Median with 95% CI will be calculated. |
| Secondary | Disease control rate | Up to 2 years after last dose of study treatment | Will be calculated as the proportion of patients with stable disease (SD), PR or CR according to RECIST v 1.1 divided by the total number of evaluable patients. Exact binomial 95% CIs for the true SD + PR + CR response rate will be calculated. |
| Secondary | Intracranial PFS rate (icPFS) | From initiation of investigational therapy to progression, symptomatic deterioration, or death due to any cause, whichever comes first, assessed up to 6 months | Will be defined as the percentage of patients without intracranial disease progression including development of new lesions, development of symptomatic lesions or leptomeningeal disease, or intervention required for disease control (such as radiation or surgery). The Kaplan-Meier method will be used to estimate icPFS. Median with 95% CI will be calculated. |
| Secondary | Best intracranial ORR | From start of investigational therapy to the first documented objective intracranial response, assessed up to 2 years after last dose of study treatment | Will be defined as the best overall intracranial response across all efficacy assessments, based on up to 5 measurable intracranial lesions (as per RECIST 1.1 criteria for measurable/target lesions) as well as unmeasurable and new intracranial disease per RECIST 1.1 principles. |
| Secondary | Median PFS | From initiation of investigational therapy until criteria for disease progression is met or death as a result of any cause, assessed up to 2 years after last dose of study treatment | Progression will be defined by RECIST v 1.1. The Kaplan-Meier method will be used to estimate PFS. Median with 95% CI will be calculated. |
| Secondary | Overall survival (OS) | From initiation of investigational therapy to date of death from any cause, assessed up to 12 months | The Kaplan-Meier method will be used to estimate OS. Median with 95% CI will be calculated. |
| Secondary | OS in patients treated with tarlatamab in first-line settings | From initiation of investigational therapy to death as a result of any cause, assessed up to 12 months | Will be defined as the percentage of patients alive. The Kaplan-Meier method will be used to estimate OS. Median with 95% CI will be calculated. |
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.
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