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A Study of SGN-B6A Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06012435
Recruitment Status : Recruiting
First Posted : August 25, 2023
Last Update Posted : May 7, 2024
Sponsor:
Information provided by (Responsible Party):
Seagen Inc.

Study Description
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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 (SGN-B6A), 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.


Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: sigvotatug vedotin Drug: docetaxel Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 21, 2024
Estimated Primary Completion Date : July 31, 2026
Estimated Study Completion Date : July 31, 2028

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
Drug Information available for: Docetaxel

Arms and Interventions
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Arm Intervention/treatment
Experimental: Experimental Arm
sigvotatug vedotin monotherapy
 Drug: sigvotatug vedotin
Given into the vein (IV; intravenously) on Day 1 and 15 of a 28-day cycle
Other Name: SGN-B6A
Active Comparator: Control Arm
Docetaxel monotherapy
 Drug: docetaxel
75 mg/m^2 given into the vein (IV; intravenously) on Day 1 of a 21-day cycle


Outcome Measures
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Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Approximately 5 years ]
    The time from date of randomization to date of death due to any cause.

  2. 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) [ Time Frame: Approximately 5 years ]
    The proportion of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1.


Secondary Outcome Measures :
  1. Progression Free Survival (PFS) per RECIST v1.1 by BICR [ Time Frame: Approximately 5 years ]
    The time from date of randomization to the first documented disease progression per RECIST v1.1 or to death due to any cause.

  2. Confirmed ORR per RECIST v1.1 by investigator assessment [ Time Frame: Approximately 5 years ]
    The proportion of participants with confirmed CR or PR according to RECIST v1.1.

  3. PFS per RECIST v1.1 by investigator assessment [ Time Frame: Approximately 5 years ]
    The time from date of randomization to the first documented disease progression per RECIST v1.1 or to death due to any cause.

  4. Duration of Response (DOR) per RECIST v1.1 by BICR [ Time Frame: Approximately 5 years ]
    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.

  5. DOR per RECIST v1.1 by investigator assessment [ Time Frame: Approximately 5 years ]
    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.

  6. Number of participants with adverse events (AEs) [ Time Frame: Through 30 days after the last study intervention; Approximately 5 years ]
    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.

  7. 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) [ Time Frame: Approximately 5 years ]
    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.

  8. Change from baseline in global health status/QoL combined score on the EORTC QLQ-C30 [ Time Frame: Approximately 5 years ]
    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.

  9. Mean score in physical functioning scores on the EORTC QLQ-C30 [ Time Frame: Approximately 5 years ]
    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.

  10. Change from baseline score in physical functioning scores on the EORTC QLQ-C30 [ Time Frame: Approximately 5 years ]
    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.

  11. Mean score in role functioning scores on the EORTC QLQ-C30 [ Time Frame: Approximately 5 years ]
    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.

  12. Change from baseline score in role functioning scores on the EORTC QLQ-C30 [ Time Frame: Approximately 5 years ]
    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.

  13. 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) [ Time Frame: Approximately 5 years ]
    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.

  14. Change from baseline in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13 [ Time Frame: Approximately 5 years ]
    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.

  15. Time to Deterioration (TTD) in the global health status/QoL combined score on the EORTC QLQ-C30 [ Time Frame: Approximately 5 years ]
    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.

  16. TTD in physical functioning scores on the EORTC QLQ-C30 [ Time Frame: Approximately 5 years ]
    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.

  17. TTD in role functioning scores on the EORTC QLQ-C30 [ Time Frame: Approximately 5 years ]
    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.

  18. TTD in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13 [ Time Frame: Approximately 5 years ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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
  • 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:

      • 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, 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 surgery
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06012435


Contacts
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Contact: Seagen Trial Information Support 866-333-7436 clinicaltrials@seagen.com

Locations
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Sponsors and Collaborators
Seagen Inc.
Investigators
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Study Director: Medical Monitor Seagen Inc.
More Information
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Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT06012435    
Other Study ID Numbers: SGNB6A-002
Be6A Lung-01 ( Other Identifier: Seagen Inc. )
First Posted: August 25, 2023    Key Record Dates
Last Update Posted: May 7, 2024
Last Verified: May 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seagen Inc.:
NSCLC
Non-Small Lung Cancer
Seattle Genetics
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action