The safety and efficacy of this agent(s), or use in this setting, has not been established or is subject to confirmation. For an agent(s) whose safety and efficacy has not been established or confirmed, future regulatory approval or commercial availability is not guaranteed.
Sigvotatug vedotin (SGN-B6A) is an investigational compound. Its safety and efficacy have not been established
Active enrolling
United States, Argentina, Australia, Austria, Belgium, Canada, Chile, Czechia, France, Germany, Greece, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Romania, Spain, Switzerland, Taiwan, United Kingdom
for more information at clinicaltrials.gov
EXPERIMENTAL: Experimental Arm
sigvotatug vedotin monotherapy
DRUG: sigvotatug vedotin
Given into the vein (IV; intravenously) on Day 1 and 15 of a 28-day cycleACTIVE_COMPARATOR: Control Arm
Docetaxel monotherapy
DRUG: docetaxel
75 mg/m\^2 given into the vein (IV; intravenously) on Day 1 of a 21-day cycleOverall Survival (OS)
The time from date of randomization to date of death due to any cause.
Approximately 5 years
Confirmed Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) as assessed by Blinded Independent Central Review (BICR)
The proportion of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1.
Approximately 5 years
Progression Free Survival (PFS) per RECIST v1.1 by BICR
The time from date of randomization to the first documented disease progression per RECIST v1.1 or to death due to any cause.
Approximately 5 years
Confirmed ORR per RECIST v1.1 by investigator assessment
The proportion of participants with confirmed CR or PR according to RECIST v1.1.
Approximately 5 years
PFS per RECIST v1.1 by investigator assessment
The time from date of randomization to the first documented disease progression per RECIST v1.1 or to death due to any cause.
Approximately 5 years
Duration of Response (DOR) per RECIST v1.1 by BICR
The time from the first documented objective response (CR or PR that is subsequently confirmed) to the first documented disease progression per RECIST v1.1 or to death due to any cause.
Approximately 5 years
DOR per RECIST v1.1 by investigator assessment
The time from the first documented objective response (CR or PR that is subsequently confirmed) to the first documented disease progression per RECIST v1.1 or to death due to any cause.
Approximately 5 years
Number of participants with adverse events (AEs)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Through 30 days after the last study intervention; Approximately 5 years
Mean score in the global health status/QoL combined score on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
The EORTC QLQ-C30 was developed as a quantitative measure of health-related quality of life (HRQoL). Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Approximately 5 years
Change from baseline in global health status/QoL combined score on the EORTC QLQ-C30
The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Approximately 5 years
Mean score in physical functioning scores on the EORTC QLQ-C30
The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Approximately 5 years
Change from baseline score in physical functioning scores on the EORTC QLQ-C30
The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Approximately 5 years
Mean score in role functioning scores on the EORTC QLQ-C30
The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Approximately 5 years
Change from baseline score in role functioning scores on the EORTC QLQ-C30
The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Approximately 5 years
Mean scores in the dyspnea, cough, and chest pain scores on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13)
The EORTC QLQ-LC13 is a lung-cancer specific module that serves as an additional 13 item questionnaire to the general EORTC cancer questionnaire. It incorporates 1 multi-item scale to assess dyspnea, and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. Scores range from 0 to 100. A high score for a symptom scale/item represents a high level of symptomatology/problems.
Approximately 5 years
Change from baseline in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13
The EORTC QLQ-LC13 is a lung-cancer specific module that serves as an additional 13 item questionnaire to the general EORTC cancer questionnaire. It incorporates 1 multi-item scale to assess dyspnea, and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. Scores range from 0 to 100. A high score for a symptom scale/item represents a high level of symptomatology/problems.
Approximately 5 years
Time to Deterioration (TTD) in the global health status/QoL combined score on the EORTC QLQ-C30
TTD is defined as the time from date of randomization to first onset of PRO deterioration with or without subsequent confirmation. The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Approximately 5 years
TTD in physical functioning scores on the EORTC QLQ-C30
TTD is defined as the time from date of randomization to first onset of PRO deterioration with or without subsequent confirmation. The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Approximately 5 years
TTD in role functioning scores on the EORTC QLQ-C30
TTD is defined as the time from date of randomization to first onset of PRO deterioration with or without subsequent confirmation. The EORTC QLQ-C30 was developed as a quantitative measure of HRQoL. Scores range from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.
Approximately 5 years
TTD in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13
TTD is defined as the time from date of randomization to first onset of PRO deterioration with or without subsequent confirmation. The EORTC QLQ-LC13 is a lung-cancer specific module that serves as an additional 13 item questionnaire to the general EORTC cancer questionnaire. It incorporates 1 multi-item scale to assess dyspnea, and a series of single items assessing pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. Scores range from 0 to 100. A high score for a symptom scale/item represents a high level of symptomatology/problems.
Approximately 5 years
560
Sponsor: Seagen Inc.
Collaborator: None
For more information, call or email the Pfizer Clinical Trial Contact Center:
When calling, please reference this study number:
NCT# stands for National Clinical Trial number. This is a unique identification code given to each clinical trial registered on ClinicalTrials.gov. The format is "NCT" followed by an 8-digit number (for example, NCT00000419). Also called the ClinicalTrials.gov identifier.
NCT06012435
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