Registered outcomes14

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

1 to 14 of 14

List	Outcome	Time frame	Description
Primary	Overall Response Rate (ORR)	Up to 8 weeks after treatment	ORR will be estimated along with 90% Confidence Intervals (CIs), and compared against the null using exact binomial test. Logistic regression model will be used to identify factors associated with response status.
Secondary	Complete Response Rate (CRR)	at 6 months after treatment	CRR is defined as all patients that achieve a CR based on end of treatment scans, using the Lugano Criteria
Secondary	Complete Response Rate (CRR)	at 12 months after treatment	CRR is defined as all patients that achieve a CR based on end of treatment scans, using the Lugano Criteria
Secondary	Complete Response Rate (CRR)	at 24 months after treatment	CRR is defined as all patients that achieve a CR based on end of treatment scans, using the Lugano Criteria
Secondary	Partial Response Rate (PRR)	at 6 months after treatment	PRR is defined as all patients that achieve a PR based on end of treatment scans, using the Lugano Criteria.
Secondary	Partial Response Rate (PRR)	at 12 months after treatment	PRR is defined as all patients that achieve a PR based on end of treatment scans, using the Lugano Criteria.
Secondary	Partial Response Rate (PRR)	at 24 months after treatment	PRR is defined as all patients that achieve a PR based on end of treatment scans, using the Lugano Criteria.
Secondary	Duration of Response (DOR)	Up to 3 years after treatment	DOR is only measured in responders. DOR is defined as the time from documented response (CR or PR) to the time of confirmed disease progression or death due to any cause, whichever occurs first. Subjects who are still alive and free from progression at the time of data cutoff date, lost to follow-up, have discontinued study, or have initiated other non-protocol anti-tumor therapy (NPT) will be censored at the last tumor assessment when subjects are progression-free.
Secondary	Progression Free Survival (PFS)	at 6 months after treatment	PFS as defined as the time from first dose to documented disease progression, or death from any cause, whichever occurs first. Data for subjects who are still alive and free from progression at the time of data cutoff date, lost to follow-up, have discontinued the study, or have initiated NPT will be censored on last assessment (or, if no post-baseline tumor assessment, at the time of first dose plus 1 day) Estimated using Kaplan-Meier method and compared using log-rank test. Cox proportional hazard model will be used to identify factors associated with survival endpoint.
Secondary	Progression Free Survival (PFS)	at 12 months after treatment	PFS as defined as the time from first dose to documented disease progression, or death from any cause, whichever occurs first. Data for subjects who are still alive and free from progression at the time of data cutoff date, lost to follow-up, have discontinued the study, or have initiated NPT will be censored on last assessment (or, if no post-baseline tumor assessment, at the time of first dose plus 1 day) Estimated using Kaplan-Meier method and compared using log-rank test. Cox proportional hazard model will be used to identify factors associated with survival endpoint.
Secondary	Progression Free Survival (PFS)	at 24 months after treatment	PFS as defined as the time from first dose to documented disease progression, or death from any cause, whichever occurs first. Data for subjects who are still alive and free from progression at the time of data cutoff date, lost to follow-up, have discontinued the study, or have initiated NPT will be censored on last assessment (or, if no post-baseline tumor assessment, at the time of first dose plus 1 day) Estimated using Kaplan-Meier method and compared using log-rank test. Cox proportional hazard model will be used to identify factors associated with survival endpoint.
Secondary	Overall Survival (OS)	Up to 3 years after treatment	Overall survival (OS) is defined as the time from first dose to death from any cause. Data for subjects who are still alive at the time of data cutoff date, lost to follow-up, have discontinued the study (or, if no post-baseline assessment, at the time of first dose plus 1 day) will be censored on last assessment Estimated using Kaplan-Meier method and compared using log-rank test. Cox proportional hazard model will be used to identify factors associated with survival endpoint.
Secondary	Time to Treatment Failure (TTF)	Up to 3 years after treatment	TTF is measured from the time from study entry to any treatment failure including discontinuation of treatment for any reason, such as disease progression, toxicity, patient preference, initiation of new treatment without documented progression, or death.
Secondary	Number of Participants With a Grade 3 Adverse Event (AE) or Higher	Up to 3 years after treatment	Safety as defined by number of participants with a grade 3 AE or higher

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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