Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Tubulin Modulators

Antimitotic Agents

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

sigvotatug vedotin

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

docetaxel

Seagen Trial Information Support

Talia Wyckoff

Steven Liu, MD

Maria Carrillo

Ravi Patel

Rebeca Sanchez

David J Park

Vu Phan

Ronald Bati

Timothy Byun

Ben Singh

Eric Bank

Robert Jotte

Venkat Kancharla

David Hakimian

Ryan Ashkar

Shaker R Dakhil

Corilynn Hughes

Benjamin Bridges

Sushma Tatineni

Holly J Desma

Charlene Fares

Christopher Sentell

John Hrom

Meng-Yun (Megan) Wu

Edwin C Kingsley

Michelle Mackenzie

Sarada Gurubhagavatula

Jessica White

Atul Kumar

Jeffrey Schneider

Zoe Swainson

David Waterhouse

Carol Tackett

Debora Bruno

Ellen Loftus

Nathan Pennell

Bo Wang

Joseph Potz

James V Uyeki

Pankaj Khandelwal

Chaney Story

Robert Droder

Pavel Levin

Katelyn Doxsee

Jerome Goldschmidt

Yiqun (Lydia) Xue

Joseph Z Ye

Anthony Van Ho

Wim Demey

Reinier Wener

Bohuslav Melichar

Milada Zemanova

Sylvere Guillemois

Gerard Zalcman

Michel Andre

Yannick Le Guen

Julien Mazieres

Virginie Westeel

Martin Faehling

Wolfgang Schutte

Andrea Fulop, MD

Zsolt Kiraly, MD

Michele Orditura

Alessandra Bulotta

Diego Cortinovis

Emilio Bria

Bjorn Henning Gronberg

Ewa Kalinka

Izabela Chmielewska

Rodryg Ramlau, MD

Maria Rosario Garcia Campelo

Luis Paz-Ares Rodriguez

Manuel Cobo Dols

Raquel Marse Fabregat

Ignacio Gil-Bazo

Oscar Jose Juan Vidal

Medical Monitor

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.

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

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

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

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

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

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

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.

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.

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.

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.

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.

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.

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.

Seagen Inc.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Digestive System Diseases

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Rare Diseases

Uterine Cervical Neoplasms

Esophageal Neoplasms

Breast Neoplasms

Adenocarcinoma

Stomach Neoplasms

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Urinary Bladder Neoplasms

Esophageal Squamous Cell Carcinoma

Neoplasms, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Stomach Diseases

Uterine Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Urologic Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Esophageal Cancer

Ovarian Cancer

Stomach Cancer

Ovarian Epithelial Cancer

Pembrolizumab

Carboplatin

Cisplatin

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

sigvotatug vedotin + pembrolizumab +/- (carboplatin or cisplatin)

sigvotatug vedotin + pembrolizumab +/- (carboplatin)

Administered into the vein (IV; intravenously)

200mg every 3 weeks or 400mg every 6 weeks, given by IV

pembrolizumab

cisplatin

AUC 5 mg/mL per min every 3 weeks, given by IV

carboplatin

Ingrid Acker

Cesar Perez Batista, MD

Alisa Posner

Bruno Bockorny, MD

Illya Dixon

Kartik Sehgal

Megan Boland

Afshin Dowlati

Providence Cancer Institute CT.Gov Contact

Rachel E Sanborn

Staci Vogel

Steven Powell

Rabia Khan

Sarina A Piha-Paul

Isabel Jimenez

Amita Patnaik

Antoine Hollebecque

Tatiana Carolina Hernandez Guerrero

Elena Garralda Cabanas

Alvaro Rodriguez Lescure

Jesus Corral

Federico Longo

Emiliano Calvo

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of SGN-B6A Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer	NCT06012435	Carcinoma, Non-...	sigvotatug vedo... docetaxel	18 Years -	Seagen Inc.
A Study of SGN-B6A Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer	NCT06012435	Carcinoma, Non-...	sigvotatug vedo... docetaxel	18 Years -	Seagen Inc.
A Study of SGN-B6A in Advanced Solid Tumors	NCT04389632	Carcinoma, Non-... Squamous Cell C... HER2 Negative B... Esophageal Squa... Esophageal Aden... Gastroesophagea... Ovarian Neoplas... Cutaneous Squam... Exocrine Pancre... Urinary Bladder... Uterine Cervica... Stomach Neoplas...	sigvotatug vedo... pembrolizumab cisplatin carboplatin	18 Years -	Seagen Inc.

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