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Anti-microtubule agent

Sigvotatug Vedotin vs Docetaxel for Lung Cancer

Phase 3
Recruiting
Research Sponsored by Seagen Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must have received specific prior therapies and progressed during or relapsed after receiving their most recent prior therapy
Histologically or cytologically confirmed diagnosis of locally advanced, unresectable (Stage IIIB, IIIC), or metastatic Stage IV (M1a, M1b, or M1c) NSCLC
Must not have
History of another malignancy within 3 years before Cycle 1 Day 1, or any evidence of residual disease from a previously diagnosed malignancy
Any systemic anticancer therapy (standard or experimental) within 21 days prior to Cycle 1 Day 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing a new drug, sigvotatug vedotin, against a standard drug, docetaxel, in patients with advanced lung cancer. The goal is to see if the new drug works better and to understand its side effects. Docetaxel (Taxotere) is a well-established chemotherapy agent used in the treatment of advanced non-small cell lung cancer (NSCLC), often after failure of first-line treatments.

Who is the study for?
This trial is for adults with advanced non-small cell lung cancer (NSCLC) that's spread or can't be surgically removed. They should have had only one prior platinum-based chemo and an anti-PD-(L)1 drug, or up to two targeted therapies if they have certain genomic alterations in their tumors.
What is being tested?
The study compares sigvotatug vedotin (SGN-B6A), a new antibody drug designed to target and kill cancer cells, against docetaxel, an approved anticancer drug. Participants will receive either SGN-B6A on Days 1 and 15 of a 28-day cycle or docetaxel on Day 1 of a 21-day cycle.
What are the potential side effects?
Possible side effects include reactions at the infusion site, fatigue, hair loss from docetaxel; specific side effects from SGN-B6A are not listed but may include similar symptoms due to its nature as an anticancer agent.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition worsened after my last treatment.
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My lung cancer is at an advanced stage and cannot be surgically removed.
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My lung cancer is non-squamous non-small cell type.
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My NSCLC has a known genetic change that can be targeted for treatment.
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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had another cancer or any remaining cancer from a past diagnosis in the last 3 years.
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I haven't had any cancer treatment in the last 3 weeks.
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I have been treated with drugs targeting cell division in advanced cancer stages.
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My doctor expects I have more than 3 months to live.
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I have moderate to severe numbness, tingling, or pain in my hands or feet.
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My diabetes is not well-controlled.
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I've had more than one chemotherapy treatment for my advanced cancer.
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I've had lung radiation over 30 Gray more than 6 months ago.
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I do not have active brain or spinal cord tumors.
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I am allergic to taxanes, docetaxel, or ingredients in sigvotatug vedotin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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)
Overall Survival (OS)
Secondary study objectives
Change from baseline in global health status/QoL combined score on the EORTC QLQ-C30
Change from baseline in the dyspnea, cough, and chest pain scores on the EORTC QLQ-LC13
Change from baseline score in physical functioning scores on the EORTC QLQ-C30
+15 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729
59%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Alanine aminotransferase increased
13%
Neurotoxicity
13%
Cough
13%
Vomting
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Headache
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental ArmExperimental Treatment1 Intervention
sigvotatug vedotin monotherapy
Group II: Control ArmActive Control1 Intervention
Docetaxel monotherapy

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Non-Small Cell Lung Cancer (NSCLC) include Antibody Drug Conjugates (ADCs) like Sigvotatug Vedotin, which target specific proteins on cancer cells to deliver cytotoxic agents directly, minimizing harm to normal cells. Chemotherapy, another common treatment, works by killing rapidly dividing cells, including cancer cells. Immunotherapy, such as anti-PD-1 or anti-PD-L1 drugs, boosts the body's immune system to recognize and attack cancer cells. These mechanisms are crucial for NSCLC patients as they offer targeted and effective treatment options, potentially improving outcomes and reducing side effects compared to traditional therapies.

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor
210 Previous Clinical Trials
73,688 Total Patients Enrolled
Medical MonitorStudy DirectorSeagen Inc.
1,674 Previous Clinical Trials
987,859 Total Patients Enrolled
~400 spots leftby Jul 2026
Unbiased ResultsWe believe in providing patients with all the options.
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