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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06012435
Registration number
NCT06012435
Ethics application status
Date submitted
21/08/2023
Date registered
25/08/2023
Date last updated
13/06/2025
Titles & IDs
Public title
A Study of SGN-B6A Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer
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Scientific title
A Randomized, Phase 3, Open-label Study to Evaluate Sigvotatug Vedotin Compared With Docetaxel in Adult Participants With Previously Treated Non-small Cell Lung Cancer (Be6A Lung-01)
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Secondary ID [1]
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C5751002
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Secondary ID [2]
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SGNB6A-002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small-Cell Lung
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - sigvotatug vedotin
Treatment: Drugs - docetaxel
Experimental: Experimental Arm - sigvotatug vedotin monotherapy
Active comparator: Control Arm - Docetaxel monotherapy
Treatment: Drugs: sigvotatug vedotin
Given into the vein (IV; intravenously) on Day 1 and 15 of a 28-day cycle
Treatment: Drugs: docetaxel
75 mg/m\^2 given into the vein (IV; intravenously) on Day 1 of a 21-day cycle
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall survival (OS) between the experimental arm (sigvotatug vedotin) and control arm (docetaxel) in all participants and in participants whose tumors express high levels of integrin beta-6 (IB6-high)
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Assessment method [1]
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The time from date of randomization to date of death due to any cause.
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Timepoint [1]
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Approximately 5 years
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Primary outcome [2]
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Progression Free Survival (PFS) per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) by Blinded Independent Central Review (BICR) between the experimental and control arms in all participants and in the IB6-high subgroup
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Assessment method [2]
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The time from date of randomization to the first documented disease progression per RECIST v1.1 or to death due to any cause.
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Timepoint [2]
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Approximately 5 years
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Secondary outcome [1]
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Confirmed Objective Response Rate (ORR) per RECIST v1.1 as assessed by BICR between the experimental and control arms in all participants and in the IB6-high subgroup
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Assessment method [1]
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The proportion of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1.
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Timepoint [1]
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Approximately 5 years
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Secondary outcome [2]
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Confirmed ORR per RECIST v1.1 by investigator assessment
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Assessment method [2]
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The proportion of participants with confirmed CR or PR according to RECIST v1.1.
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Timepoint [2]
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Approximately 5 years
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Secondary outcome [3]
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PFS per RECIST v1.1 by investigator assessment
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Assessment method [3]
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The time from date of randomization to the first documented disease progression per RECIST v1.1 or to death due to any cause.
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Timepoint [3]
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Approximately 5 years
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Secondary outcome [4]
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Duration of Response (DOR) per RECIST v1.1 by BICR
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Assessment method [4]
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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.
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Timepoint [4]
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Approximately 5 years
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Secondary outcome [5]
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DOR per RECIST v1.1 by investigator assessment
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Assessment method [5]
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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.
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Timepoint [5]
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Approximately 5 years
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Secondary outcome [6]
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Number of participants with adverse events (AEs)
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Assessment method [6]
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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.
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Timepoint [6]
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Through 30 days after the last study intervention; Approximately 5 years
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Secondary outcome [7]
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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)
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Assessment method [7]
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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.
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Timepoint [7]
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Approximately 5 years
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Secondary outcome [8]
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Change from baseline in global health status/QoL combined score on the EORTC QLQ-C30
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Assessment method [8]
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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.
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Timepoint [8]
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Approximately 5 years
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Secondary outcome [9]
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Mean score in physical functioning scores on the EORTC QLQ-C30
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Assessment method [9]
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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.
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Timepoint [9]
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Approximately 5 years
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Secondary outcome [10]
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Change from baseline score in physical functioning scores on the EORTC QLQ-C30
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Assessment method [10]
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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.
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Timepoint [10]
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Approximately 5 years
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Secondary outcome [11]
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Mean score in role functioning scores on the EORTC QLQ-C30
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Assessment method [11]
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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.
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Timepoint [11]
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Approximately 5 years
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Secondary outcome [12]
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Change from baseline score in role functioning scores on the EORTC QLQ-C30
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Assessment method [12]
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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.
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Timepoint [12]
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Approximately 5 years
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Secondary outcome [13]
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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)
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Assessment method [13]
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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.
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Timepoint [13]
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Approximately 5 years
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Secondary outcome [14]
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Change from baseline in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13
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Assessment method [14]
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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.
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Timepoint [14]
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Approximately 5 years
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Secondary outcome [15]
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Time to Deterioration (TTD) in the global health status/QoL combined score on the EORTC QLQ-C30
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Assessment method [15]
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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.
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Timepoint [15]
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Approximately 5 years
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Secondary outcome [16]
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TTD in physical functioning scores on the EORTC QLQ-C30
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Assessment method [16]
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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.
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Timepoint [16]
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Approximately 5 years
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Secondary outcome [17]
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TTD in role functioning scores on the EORTC QLQ-C30
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Assessment method [17]
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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.
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Timepoint [17]
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Approximately 5 years
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Secondary outcome [18]
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TTD in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13
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Assessment method [18]
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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.
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Timepoint [18]
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Approximately 5 years
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Eligibility
Key inclusion criteria
* Histologically or cytologically confirmed diagnosis of locally advanced, unresectable (Stage IIIB, IIIC), or metastatic Stage IV (M1a, M1b, or M1c) NSCLC American Joint Committee on Cancer (AJCC) Staging Manual, Version 8.0, and the Union for International Cancer Control (UICC) Staging System (Eighth edition).
* Participants must have NSCLC with nonsquamous histology
* Tumors with squamous, or predominantly squamous histology are excluded.
* Tumors with small cell elements are excluded.
* Participants who have NSCLC with known actionable genomic alteration (AGAs) are permitted
* Participants must have received the following prior therapies and progressed during or relapsed after receiving their most recent prior therapy:
* Participants with no known AGAs must fulfill 1 of the following conditions:
* Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease and a PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy), unless contraindicated.
* Experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant or neoadjuvant setting and received a PD-(L)1 monoclonal antibody at any time during the course of treatment.
* Participants with known AGAs must fulfill the following conditions:
* Must have received at least 1 relevant AGA targeted therapy and in the opinion of the investigator, additional AGA targeted therapy is not in the best interest of the participant.
* Received a platinum-based combination therapy for the treatment of metastatic or recurrent disease, or experienced disease progression within 6 months of the last dose of platinum-based chemotherapy in the adjuvant or neoadjuvant setting
* May have received up to 1 PD-(L)1 monoclonal antibody (concurrently or sequentially with platinum-based chemotherapy).
* Measurable disease based on RECIST v1.1
* Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with adequate baseline hematologic, hepatic, and renal function and measurable disease according to RECIST v1.1
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Life expectancy of less than (<) 3 months
* Known allergies/hypersensitivity/intolerance to or contraindication of taxanes, docetaxel, or any excipient contained in the drug formulation of sigvotatug vedotin
* History of another malignancy within 3 years before Cycle 1 Day 1, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death
* Participants with any of the following respiratory conditions:
* Evidence of noninfectious interstitial lung disease (ILD) or pneumonitis that:
* Was previous diagnosed and required systemic steroids, or
* Is currently diagnosed and managed, or
* Is suspected on radiologic imaging at screening
* Known diffusing capacity of the lung for carbon monoxide (DLCO) < 50%
* Any Grade greater than or equal to (=) 3 pulmonary disease unrelated to underlying malignancy
* Pre-existing peripheral neuropathy Grade greater than or equal to (=) 2
* Uncontrolled diabetes mellitus
* Prior therapy:
* Prior treatment with antimicrotubule agents (taxanes, vinca alkaloids, or MMAEs) in the locally advanced, unresectable/refractory, or metastatic setting
* Prior antimicrotubule agent exposure in curative settings (including adjuvant, neoadjuvant, or chemoradiotherapy) is permissible.
* Received more than 1 prior line of cytotoxic chemotherapy in the locally advanced, unresectable/refractory, or metastatic setting
* Prior cytotoxic chemotherapy in curative settings is permissible
* At least 14 days must have elapsed from the last dose of radiotherapy until Cycle 1 Day 1.
* Prior radiation therapy to the lung parenchyma that is >30 Gray (Gy) within 6 months of Cycle 1 Day 1.
* Any systemic anticancer therapy (standard or experimental) within 21 days prior to Cycle 1 Day 1.
* Active central nervous system (CNS) lesions, including leptomeningeal metastasis, are excluded. Participants with definitively treated brain metastases are eligible in they meet the following criteria:
* Have been clinically stable for at least 4 weeks prior to treatment initiation and baseline scans show no evidence of new or enlarged metastasis
* On a stable dose of less than or equal to (=) 10mg/day of prednisone or equivalent for a least 2 weeks (if requiring steroid treatment)
* Treatment with corticosteroids greater than (>) 1 month prior to Screening visit
* No evidence of clinical and radiographic disease progression in the CNS for = 21 days after definitive radiotherapy and/or surgery
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/02/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
11/03/2028
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Actual
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Sample size
Target
670
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
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Recruitment hospital [1]
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Border Medical Oncology - Albury
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Recruitment hospital [2]
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Ramsay Health Care Australia Pty Ltd - Albury
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Recruitment hospital [3]
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GenesisCare Kingswood - Kingswood
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Recruitment hospital [4]
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Calvary Mater Newcastle - Waratah
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Recruitment hospital [5]
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Princess Alexandra Hospital - Woolloongabba
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Recruitment hospital [6]
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The Alfred Hospital - Melbourne
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Recruitment hospital [7]
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St John of God Hospital Murdoch - Murdoch
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Recruitment hospital [8]
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Frankston Hospital - Frankston
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Recruitment postcode(s) [1]
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2640 - Albury
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Recruitment postcode(s) [2]
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2747 - Kingswood
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Recruitment postcode(s) [3]
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2298 - Waratah
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Recruitment postcode(s) [4]
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4102 - Woolloongabba
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Recruitment postcode(s) [5]
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3004 - Melbourne
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Recruitment postcode(s) [6]
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6150 - Murdoch
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Recruitment postcode(s) [7]
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3199 - Frankston
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Recruitment outside Australia
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United States of America
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Alabama
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United States of America
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Alaska
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Arizona
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California
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Colorado
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Connecticut
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Florida
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Illinois
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Maryland
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Massachusetts
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Minnesota
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Mississippi
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Rosario
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Austria
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Graz
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Edegem
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Ontario
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Santiago
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China
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Anhui
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China
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Fujian
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China
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Guangdong
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China
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Guangxi
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China
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Henan
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China
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Hubei
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China
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China
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China
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Jiangxi
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China
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Jilin
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China
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Shandong
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China
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Shanxi
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China
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Sichuan
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China
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TIAN JIN
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China
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Zhejiang
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China
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Beijing
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China
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Chongqing
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China
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Shanghai
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Olomouc
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Ostrava
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Czechia
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Praha 2
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France
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VAR
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France
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Besancon
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Cholet
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France
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France
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Lille
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France
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France
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Paris
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France
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Pessac
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France
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Quimper
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France
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Rennes Cedex 9
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France
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Strasbourg
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France
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Toulouse
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France
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Villejuif
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Bonn
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Germany
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Esslingen
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Germany
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Frankfurt
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Germany
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Gauting
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Germany
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Grosshansdorf
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Germany
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Halle
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Germany
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Heidelberg
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Germany
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Kassel
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Germany
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Luebeck
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Germany
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Munster
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Thessaly
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Greece
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Athens
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Greece
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Cholargos
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Greece
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N.Faliro
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Greece
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Patras
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Greece
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Pilea
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Greece
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Thessaloniki
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Hungary
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Budapest
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Hungary
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Farkasgyepu
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Hungary
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Veszprem
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Israel
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Other
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Israel
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Jerusalem
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Israel
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Kfar Saba
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Israel
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Petah Tikva
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Israel
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Rehovot
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Italy
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Ancona
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Italy
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Campania
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Italy
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Italy
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Lazio
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Italy
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Lombardy
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Italy
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MB
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Italy
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Pordenone
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Italy
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Italy
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Rome
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Italy
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Sicily
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Italy
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Catania
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Italy
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Genova
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Italy
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Parma
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Japan
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Aichi
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Japan
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Chiba
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Japan
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Ehime
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Japan
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Fukuoka
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Japan
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Hyogo
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Japan
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Ishikawa
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Japan
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Japan
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Japan
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Osaka
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Japan
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Other
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Japan
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Japan
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Tokyo
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Netherlands
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Groningen
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Maastricht
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Drammen
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Romania
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Koblenz
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Romania
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Spain
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A Coruna
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Spain
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Alicante
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Chur
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Lausanne
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Changhua
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Kaohsiung
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Taipei
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United Kingdom
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Others
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United Kingdom
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Other
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United Kingdom
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Glasgow
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Leeds
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London
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United Kingdom
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Manchester
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United Kingdom
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Seagen, a wholly owned subsidiary of Pfizer
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This clinical trial is studying nonsquamous non-small cell lung cancer (NSCLC). Participants in this study must have cancer that has spread through their body or can't be removed with surgery. Participants in this study must have been treated with no more than a platinum-based chemotherapy and an anti-PD-(L)1 drug. Participants with tumors that have certain treatable genomic alterations must have had at least 1 drug for that genomic alteration, in addition to platinum-based chemotherapy. This clinical trial uses an experimental drug called sigvotatug vedotin, which is a type of antibody drug conjugate or ADC. ADCs are designed to stick to cancer cells and kill them. This clinical trial also uses a drug called docetaxel. Docetaxel is an anticancer drug that has been approved to treat non-small cell lung cancer. It is usually given to patients who previously received another anticancer treatment. In this study, one group of participants will get sigvotatug vedotin on Days 1 and 15 during each 28-day-cycle. A second group of participants will get docetaxel on Day 1 during each 21-day cycle. This study is being done to see if sigvotatug vedotin works better than docetaxel to treat participants with NSCLC. This study will also test what side effects happen when participants take these drugs. A side effect is anything a drug does to the body besides treating the disease.
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Trial website
https://clinicaltrials.gov/study/NCT06012435
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Public notes
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Contacts
Principal investigator
Name
0
0
Pfizer CT.gov Call Center
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Address
0
0
Pfizer
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Country
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0
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Phone
0
0
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Fax
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0
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Email
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0
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Contact person for public queries
Name
0
0
Pfizer CT.gov Call Center
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Address
0
0
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Country
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0
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Phone
0
0
1-800-718-1021
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Fax
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0
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Email
0
0
[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06012435
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