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Clinical Trials in the UK / NCT06012435
Active, not recruiting Phase 3

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

NCT06012435 · tracked via the Priya Life Science UK tracker
Sponsor
Seagen, a wholly owned subsidiary of Pfizer
Phase
Phase 3
Started
2024-02-21
Last updated
2026-07-23

Condition(s) studied

Carcinoma, Non-Small-Cell Lung

Investigational drug(s) / intervention(s)

sigvotatug vedotindocetaxel

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

Study 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, 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 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

Primary outcome measure(s)

Trial sites (331)

FacilityCityRegionStatus
Alaska Oncology and Hematology, LLC Anchorage Alaska
Providence Medical Foundation Fullerton California
Providence St. Jude Medical Center Virginia K. Crosson Cancer Center and Infusion Center Fullerton California
Providence St. Jude Medical Center Fullerton California
Cancer and Blood Specialty Clinic Los Alamitos California
Cancer Blood and Specialty Clinic Los Alamitos California
Regulatory Management Only: TRIO-US Central Administration Los Angeles California
Drug Management Only: UCLA West Medical Pharmacy Attn: Steven L. Wong, Pharma.D. Los Angeles California
Drug Management Only: UCLA West Medical Pharmacy, Attn: Steven L Wong, Pharm.D. Los Angeles California
UCSF Medical Center - Mission Bay San Francisco California
Sansum Clinic Santa Barbara California
Sansum Clinic Solvang California
Rocky Mountain Cancer Centers LLP Aurora Colorado
Rocky Mountain Cancer Centers LLP Boulder Colorado
Rocky Mountain Cancer Centers LLP Colorado Springs Colorado
Rocky Mountain Cancer Centers LLP Colorado Springs Colorado
Rocky Mountain Cancer Centers LLP Denver Colorado
Rocky Mountain Cancer Centers LLP Denver Colorado
Rocky Mountain Cancer Centers LLP Lakewood Colorado
Rocky Mountain Cancer Centers LLP Littleton Colorado
Rocky Mountain Cancer Centers LLP Lone Tree Colorado
Rocky Mountain Cancer Centers LLP Longmont Colorado
Rocky Mountain Cancer Centers LLP Pueblo Colorado
Rocky Mountain Cancer Centers LLP Thornton Colorado
Cancer Specialists of North Florida Fleming Island Florida
Cancer Specialists of North Florida Jacksonville Florida
Cancer Specialists of North Florida Jacksonville Florida
Cancer Specialists of North Florida Jacksonville Florida
Cancer Specialists of North Florida Jacksonville Florida
Cancer Care Centers of Brevard, Inc. Melbourne Florida
Baptist Hospital of Miami Miami Florida
Miami Cancer Institute at Baptist Health, Inc. Miami Florida
Cancer Specialists of North Florida Neptune Beach Florida
Cancer Care Centers of Brevard, Inc. Palm Bay Florida
Cancer Care Centers of Brevard, Inc. Rockledge Florida
Cancer Specialists of North Florida Saint Augustine Florida
Illinois Cancer Specialists Arlington Heights Illinois
Illinois Cancer Specialists Niles Illinois
Maryland Oncology Hematology P.A. Annapolis Maryland
Maryland Oncology Hematology P.A. Bethesda Maryland

+ 291 more sites — see the full list on the official registry below.

More Seagen, a wholly owned subsidiary of Pfizer trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06012435 on ClinicalTrials.gov ↗ ← All trials in the UK