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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

Titles & IDs
Public title
A Study of Sigvotatug Vedotin Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer
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)
Secondary ID [1] 0 0
C5751002
Secondary ID [2] 0 0
SGNB6A-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Carcinoma, Non-Small-Cell Lung 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
Approximately 5 years
Primary outcome [2] 0 0
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
Timepoint [2] 0 0
Approximately 5 years
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Approximately 5 years
Secondary outcome [2] 0 0
Confirmed ORR per RECIST v1.1 by investigator assessment
Timepoint [2] 0 0
Approximately 5 years
Secondary outcome [3] 0 0
PFS per RECIST v1.1 by investigator assessment
Timepoint [3] 0 0
Approximately 5 years
Secondary outcome [4] 0 0
Duration of Response (DOR) per RECIST v1.1 by BICR
Timepoint [4] 0 0
Approximately 5 years
Secondary outcome [5] 0 0
DOR per RECIST v1.1 by investigator assessment
Timepoint [5] 0 0
Approximately 5 years
Secondary outcome [6] 0 0
Number of participants with adverse events (AEs)
Timepoint [6] 0 0
Through 30 days after the last study intervention; Approximately 5 years
Secondary outcome [7] 0 0
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)
Timepoint [7] 0 0
Approximately 5 years
Secondary outcome [8] 0 0
Change from baseline in global health status/QoL combined score on the EORTC QLQ-C30
Timepoint [8] 0 0
Approximately 5 years
Secondary outcome [9] 0 0
Mean score in physical functioning scores on the EORTC QLQ-C30
Timepoint [9] 0 0
Approximately 5 years
Secondary outcome [10] 0 0
Change from baseline score in physical functioning scores on the EORTC QLQ-C30
Timepoint [10] 0 0
Approximately 5 years
Secondary outcome [11] 0 0
Mean score in role functioning scores on the EORTC QLQ-C30
Timepoint [11] 0 0
Approximately 5 years
Secondary outcome [12] 0 0
Change from baseline score in role functioning scores on the EORTC QLQ-C30
Timepoint [12] 0 0
Approximately 5 years
Secondary outcome [13] 0 0
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)
Timepoint [13] 0 0
Approximately 5 years
Secondary outcome [14] 0 0
Change from baseline in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13
Timepoint [14] 0 0
Approximately 5 years
Secondary outcome [15] 0 0
Time to Deterioration (TTD) in the global health status/QoL combined score on the EORTC QLQ-C30
Timepoint [15] 0 0
Approximately 5 years
Secondary outcome [16] 0 0
TTD in physical functioning scores on the EORTC QLQ-C30
Timepoint [16] 0 0
Approximately 5 years
Secondary outcome [17] 0 0
TTD in role functioning scores on the EORTC QLQ-C30
Timepoint [17] 0 0
Approximately 5 years
Secondary outcome [18] 0 0
TTD in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13
Timepoint [18] 0 0
Approximately 5 years

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
11/03/2028
Actual
Sample size
Target
670
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,OtherQLD,VIC,WA
Recruitment hospital [1] 0 0
Border Medical Oncology - Albury
Recruitment hospital [2] 0 0
Ramsay Health Care Australia Pty Ltd - Albury
Recruitment hospital [3] 0 0
GenesisCare Kingswood - Kingswood
Recruitment hospital [4] 0 0
Calvary Mater Newcastle - Waratah
Recruitment hospital [5] 0 0
St. John of God Hospital Murdoch - Murdoch
Recruitment hospital [6] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [7] 0 0
The Alfred Hospital - Melbourne
Recruitment hospital [8] 0 0
St John of God Hospital Murdoch - Murdoch
Recruitment hospital [9] 0 0
Frankston Hospital - Frankston
Recruitment postcode(s) [1] 0 0
2640 - Albury
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
2298 - Waratah
Recruitment postcode(s) [4] 0 0
6150 - Murdoch
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
3004 - Melbourne
Recruitment postcode(s) [7] 0 0
3199 - Frankston
Recruitment outside Australia
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United States of America
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Alabama
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Alaska
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Country [170] 0 0
Switzerland
State/province [170] 0 0
Basel
Country [171] 0 0
Switzerland
State/province [171] 0 0
Bern
Country [172] 0 0
Switzerland
State/province [172] 0 0
Chur
Country [173] 0 0
Switzerland
State/province [173] 0 0
Lausanne
Country [174] 0 0
Switzerland
State/province [174] 0 0
Zurich
Country [175] 0 0
Taiwan
State/province [175] 0 0
Other
Country [176] 0 0
Taiwan
State/province [176] 0 0
Changhua
Country [177] 0 0
Taiwan
State/province [177] 0 0
Kaohsiung
Country [178] 0 0
Taiwan
State/province [178] 0 0
Taipei
Country [179] 0 0
United Kingdom
State/province [179] 0 0
NEW Hampshire
Country [180] 0 0
United Kingdom
State/province [180] 0 0
Others
Country [181] 0 0
United Kingdom
State/province [181] 0 0
Other
Country [182] 0 0
United Kingdom
State/province [182] 0 0
Glasgow
Country [183] 0 0
United Kingdom
State/province [183] 0 0
Leeds
Country [184] 0 0
United Kingdom
State/province [184] 0 0
London
Country [185] 0 0
United Kingdom
State/province [185] 0 0
Sutton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Seagen, a wholly owned subsidiary of Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Country 0 0
Phone 0 0
1-800-718-1021
Fax 0 0
Email 0 0
[email protected]
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