Registered outcomes18

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 18 of 18

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List	Outcome	Time frame	Description
Primary	To estimate the objective response rate (ORR)	Within the 4 months of treatment initiation
Secondary	Objective response rate at different timepoints (ORR)	up to 18 months
Secondary	Duration of response (DOR)	From cycle 3 (Week 6; each cycle is 28 days) up to 2 years after the EoT, an average of 26 months	defined as the time from the date of the first documentation of objective response (CR or PR) to the date of the first documentation of progression (PD) or death due to any cause. Duration of response will be measured for responding patients (CR or PR) only
Secondary	Clinical benefit rate (CBR)	During treatment period, a median of 4 months	defined as the presence of at least a PR or CR, or a stable disease (SD) \>6 months
Secondary	Progression free survival (PFS)	From the time date of the first dose until progression or death from any cause, whichever occurs first, assessed up to 18 months	defined as the time from date of first dose until the date of the first objective documentation of disease progression or death from any cause, whichever occurs first. For patients without documented radiological progression, follow-up will be censored at the date of last radiological assessment without progression, unless death occurs within 12 weeks following the date of last known progression-free, in which case the death will be counted as a PFS event
Secondary	Frequency of all adverse events	From enrollment until 24 months of EoT
Secondary	Severity of all adverse events	From enrollment until 24 months of EoT	As defined by the NCI-CTCAE v5.0.
Secondary	frequency of CRS and ICANS	From enrollment until 24 months of EoT	graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria
Secondary	severity of CRS and ICANS	From enrollment until 24 months of EoT	graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria
Secondary	Proportion of treatment discontinuation due to any AEs	Treatment Period, median of 4 months
Secondary	Proportion of treatment interruptions due to any AEs.	Treatment Period, median of 4 months
Secondary	Proportion of dose reductions due to any AEs	Treatment Period, median of 4 months
Secondary	Severity of laboratory abnormalities	From enrollment until 24 months of EoT	Defined by NCI-CTCAE v5.0
Secondary	Frequency of laboratory abnormalities	From enrollment until 24 months of EoT
Other	mechanisms of action of tarlatamab	from enrollment unti EoT, with a median of 4 months
Other	mechanisms of resistance of tarlatamab	from enrollment unti EoT, with a median of 4 months
Other	Description of patient-reported outcomes (PROs)	Treatment Period, median of 4 months	physical functioning sub-scale score of the EORTC QLQ-C30
Other	Description of patient-reported outcomes (PROs)	Treatment Period, median of 4 months	QoL scale score of the EORTC QLQ-LC13

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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GET https://conductscience.org/api/trials/v1/NCT07016230/registered

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