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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06012435
• Other study ID #: SGNB6A-002
• Secondary ID: Be6A Lung-01
• Status: Recruiting
• Phase: Phase 3
• Start date: February 21, 2024
• Est. completion date: July 31, 2028

Study information

• Verified date: June 2024
• Source: Seagen Inc.
• Contact: Seagen Trial Information Support
• Phone: 866-333-7436
• Email: clinicaltrials[@]seagen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: July 31, 2028
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Intervention

Drug:
• sigvotatug vedotin
Given into the vein (IV; intravenously) on Day 1 and 15 of a 28-day cycle
• docetaxel
75 mg/m^2 given into the vein (IV; intravenously) on Day 1 of a 21-day cycle

Locations

Country	Name	City	State
Belgium	Algemeen Ziekenhuis Klina	Brasschaat	Other
Belgium	Universitair Ziekenhuis Antwerpen	Edegem	Other
Belgium	University Hospital Ghent	Ghent	Other
Canada	University of Alberta / Cross Cancer Institute	Edmonton	Alberta
Czechia	Fakultni Nemocnice Olomouc (Fnol) - Onkologicka Klinika	Olomouc	Other
Czechia	Vseobecna fakultni nemocnice v Praze	Prague	Other
France	University Hospital of Besancon	Besancon Cedex
France	Centre Hospitalier de Cholet	Cholet	Other
France	Centre Hospitalier Intercommunal Creteil - CHI Creteil	Creteil	Other
France	CHRU de Lille	Lille	Other
France	Centre de Cancerologie du Grand Montpellier	Montpellier	Other
France	Hopital Bichat-Claude Bernard - APHP	Paris	Other
France	Hopital Cochin	Paris	Other
France	Hospital Center De Cornouaille	Quimper Cedex	Other
France	Centre Hospitalier Universitaire de Rennes, Hopital Pontchaillou	Rennes	Other
France	Institut de cancerologie Strasbourg Europe	Strasbourg	Other
France	Chits Sainte Musse	Toulon	Other
France	CHU Toulouse - hopital Larrey	Toulouse	Other
Germany	Klinikum Esslingen GmbH	Esslingen	Other
Germany	Asklepios Klinik Gauting GmbH	Gauting	Other
Germany	Krankenhaus Martha-Maria Halle-Dölau GmbH	Halle	Other
Greece	Alexandra General Hospital of Athens	Athens	Other
Hungary	National Koranyi Institute of Pulmonology	Budapest	Other
Hungary	Farkasgyepui Tudogyogyintezet	Farkasgyepu	Other
Italy	Azienda Ospedaliera di Rilievo Nazionale Sant'Anna e San Sebastiano	Caserta	Other
Italy	Ospedale San Raffaele	Milano	Other
Italy	Fondazione IRCCS San Gerardo dei Tintori	Monza	Other
Italy	Istituto Nazionale Tumori 'Regina Elena'	Roma	Other
Italy	Policlinico Universitario Agostino Gemelli	Roma	Other
Netherlands	Erasmus Medisch Centrum Daniel Den Hoed	Rotterdam	Other
Norway	Vestre Viken Health Trust	Drammen	Other
Norway	Oslo University Hospital	Oslo	Other
Norway	St. Olavs Hospital	Trondheim	Other
Poland	Instytut MSF Sp zoo	Lodz	Other
Poland	Institute of Genetics and Immunology GENIM LCC	Lublin	Other
Poland	Med Polonia Sp. z o. o.	Poznan	Other
Romania	Oncocenter-Oncologie Clinica SRL	Timisoara	Other
Spain	Complejo Hospitalario Universitario La Coruna	A Coruna	Other
Spain	Hospital General Universitario Gregorio Maranon	Madrid	Other
Spain	Hospital Universitario 12 de Octubre	Madrid	Other
Spain	Hospital Quiron Salud Malaga	Malaga	Other
Spain	Hospital Universitario Son Espases	Palma de Mallorca	Other
Spain	Fundación Instituto Valenciano de Oncología (FIVO)	Valencia	Other
Spain	Hospital Universitari i Politecnic La Fe de Valencia	Valencia	Other
United States	New Mexico Cancer Center	Albuquerque	New Mexico
United States	Alaska Oncology and Hematology	Anchorage	Alaska
United States	Maryland Oncology Hematology, P.A.	Annapolis	Maryland
United States	Texas Oncology	Austin	Texas
United States	Comprehensive Blood and Cancer Center TRIO	Bakersfield	California
United States	Oncology and Hematology Associates of Southwest Virginia	Blacksburg	Virginia
United States	Oncology Hematology Care	Cincinnati	Ohio
United States	Cleveland Clinic Fairview Hospital	Cleveland	Ohio
United States	Cleveland Clinic, The	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Willamette Valley Cancer Institute and Research Center	Eugene	Oregon
United States	Summit Medical Group	Florham Park	New Jersey
United States	Providence Medical Foundation	Fullerton	California
United States	Hattiesburg Clinic Hematology/Oncology	Hattiesburg	Mississippi
United States	Alliance Cancer Specialists, PC	Horsham	Pennsylvania
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Rocky Mountain Cancer Centers - Aurora	Lone Tree	Colorado
United States	Cancer and Blood Specialty Clinic	Los Alamitos	California
United States	Cleveland Clinic Hillcrest Hospital	Mayfield Heights	Ohio
United States	NYU Langone Hospital	Mineola	New York
United States	Allina Health Cancer Institute	Minneapolis	Minnesota
United States	Minnesota Oncology Hematology P.A.	Minneapolis	Minnesota
United States	NYU Langone Hospital	New York	New York
United States	Illinois Cancer Care	Niles	Illinois
United States	Texas Oncology	Odessa	Texas
United States	Vista Oncology Inc PS	Olympia	Washington
United States	St. Joseph Hospital Orange	Orange	California
United States	Cancer Care Centers of Brevard, Inc.	Palm Bay	Florida
United States	Sansum Clinic	Santa Barbara	California
United States	UT Health East Texas Hope Cancer Center	Tyler	Texas
United States	Northwest Cancer Centers, P.C.	Vancouver	Washington
United States	Texas Oncology	Webster	Texas
United States	Cancer Center of Kansas	Wichita	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Seagen Inc.

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival (OS)	The time from date of randomization to date of death due to any cause.	Approximately 5 years
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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