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.

Clinical Trial Details

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Thoracic Cancer

Sigvotatug vedotin

Sigvotatug vedotin (SGN-B6A) is an investigational compound. Its safety and efficacy have not been established

A Randomized, Phase 3, Open-label Study to Evaluate SGN-B6A Compared With Docetaxel in Adult Subjects With Previously Treated Non-small Cell Lung Cancer
Phase 3
NCT06012435

Active enrolling

Globe
Locations

United States, Belgium, Canada, Czechia, France, Germany, Greece, Hungary, Italy, Norway, Poland, Spain

Study design

Participant Group/Arm

EXPERIMENTAL: Experimental Arm

sigvotatug vedotin monotherapy

Intervention/Treatment

DRUG: sigvotatug vedotin

Given into the vein (IV; intravenously) on Day 1 and 15 of a 28-day cycle

Participant Group/Arm

ACTIVE_COMPARATOR: Control Arm

Docetaxel monotherapy

Intervention/Treatment

DRUG: docetaxel

75 mg/m\^2 given into the vein (IV; intravenously) on Day 1 of a 21-day cycle

Key eligibility criteria

Inclusion criteria
  • Histologically or cytologically confirmed diagnosis of locally advanced, unresectable (Stage IIIB, IIIC), or metastatic Stage IV (M1a, M1b, or M1c) NSCLC
  • Participants must have NSCLC with nonsquamous histology
    • Tumors with squamous, or predominantly squamous histology are excluded.
    • Tumors with small cell elements are exclude
  • 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:
  • Participants must have received the following prior therapies and progressed during or relapsed after receiving their most recent prior therapy:
    • Participants with known AGAs must fulfill the following conditions:
  • Measurable disease based on RECIST v1.1
  • Eastern cooperative Oncology Group (ECOG) performance status score of 0 or 1
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:
  • Participants with any of the following respiratory conditions:
    • Known diffusing capacity of the lung for carbon monoxide (DLCO) \< 50%
    • Any Grade greater than or equal to (≥) 3 pulmonary disease unrelated to underlying malignan
  • 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, or metastatic setting * Received more than 1 prior line of cytotoxic chemotherapy in the locally advanced, unresectable, or metastatic setting * 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 surge

Key dates

Study start date
  • February 2024
Estimated primary completion date
  • July 2028

Key endpoints

Primary Outcome Measures
Outcome Measure

Overall Survival (OS)

Measure Description

The time from date of randomization to date of death due to any cause.

Time Frame

Approximately 5 years

Outcome Measure

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)

Measure Description

The proportion of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1.

Time Frame

Approximately 5 years

Secondary Outcome Measures:
Outcome Measure

Progression Free Survival (PFS) per RECIST v1.1 by BICR

Measure Description

The time from date of randomization to the first documented disease progression per RECIST v1.1 or to death due to any cause.

Time Frame

Approximately 5 years

Outcome Measure

Confirmed ORR per RECIST v1.1 by investigator assessment

Measure Description

The proportion of participants with confirmed CR or PR according to RECIST v1.1.

Time Frame

Approximately 5 years

Outcome Measure

PFS per RECIST v1.1 by investigator assessment

Measure Description

The time from date of randomization to the first documented disease progression per RECIST v1.1 or to death due to any cause.

Time Frame

Approximately 5 years

Outcome Measure

Duration of Response (DOR) per RECIST v1.1 by BICR

Measure Description

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.

Time Frame

Approximately 5 years

Outcome Measure

DOR per RECIST v1.1 by investigator assessment

Measure Description

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.

Time Frame

Approximately 5 years

Outcome Measure

Number of participants with adverse events (AEs)

Measure Description

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.

Time Frame

Through 30 days after the last study intervention; Approximately 5 years

Outcome Measure

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)

Measure Description

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.

Time Frame

Approximately 5 years

Outcome Measure

Change from baseline in global health status/QoL combined score on the EORTC QLQ-C30

Measure Description

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.

Time Frame

Approximately 5 years

Outcome Measure

Mean score in physical functioning scores on the EORTC QLQ-C30

Measure Description

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.

Time Frame

Approximately 5 years

Outcome Measure

Change from baseline score in physical functioning scores on the EORTC QLQ-C30

Measure Description

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.

Time Frame

Approximately 5 years

Outcome Measure

Mean score in role functioning scores on the EORTC QLQ-C30

Measure Description

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.

Time Frame

Approximately 5 years

Outcome Measure

Change from baseline score in role functioning scores on the EORTC QLQ-C30

Measure Description

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.

Time Frame

Approximately 5 years

Outcome Measure

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)

Measure Description

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.

Time Frame

Approximately 5 years

Outcome Measure

Change from baseline in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13

Measure Description

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.

Time Frame

Approximately 5 years

Outcome Measure

Time to Deterioration (TTD) in the global health status/QoL combined score on the EORTC QLQ-C30

Measure Description

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.

Time Frame

Approximately 5 years

Outcome Measure

TTD in physical functioning scores on the EORTC QLQ-C30

Measure Description

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.

Time Frame

Approximately 5 years

Outcome Measure

TTD in role functioning scores on the EORTC QLQ-C30

Measure Description

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.

Time Frame

Approximately 5 years

Outcome Measure

TTD in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13

Measure Description

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.

Time Frame

Approximately 5 years

Number of participants

600

Collaborators and investigators

Sponsor: Seagen Inc.

Collaborator: None

This information is current as of June 4th 2024.