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Anti-microtubule agent

Experimental Arm for Non-Small Cell 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 5 years

Awards & highlights

Study Summary

This trial is testing a new drug, sigvotatug vedotin, for the treatment of a specific type of lung cancer that has spread throughout the body or cannot be removed with surgery.

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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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%

Neurotoxicity

13%

Alanine aminotransferase increased

13%

Cough

13%

Vomting

Headache

Musculoskeletal pain

Aspartate aminotransferase increased

Chest discomfort

Rash

Pigmentation disorder

Nausea

Bone marrow failure

Anaemia

Transaminases increased

Insomnia

Constipation

Mouth ulceration

Nasopharyngitis

Paronychia

Flushing

Face oedema

Thrombocytopenia

Infection

Upper respiratory tract infection

Completed suicide

Cataract

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab

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

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Seagen Inc.Lead Sponsor

208 Previous Clinical Trials

73,628 Total Patients Enrolled

Medical MonitorStudy DirectorSeagen Inc.

1,660 Previous Clinical Trials

983,229 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there ongoing efforts to actively enroll participants for this clinical trial?

"The search for eligible participants is ongoing, as indicated on clinicaltrials.gov. This trial was initially listed on March 31st, 2024 and most recently revised on February 9th, 2024."

Answered by AI

What is the number of individuals currently undergoing treatment within this medical study?

"Affirmative. Information accessible on clinicaltrials.gov indicates that this medical investigation is presently seeking participants. Initially shared on March 31st, 2024, the most recent update was made on February 9th of the same year. The research aims to enlist a total of 600 patients from two separate sites."

Answered by AI

What is the safety profile of the experimental treatment group for study participants?

"Based on our assessment at Power, the safety rating for the Experimental Arm is graded as 3 due to its classification in Phase 3 trials. This signifies existing evidence of effectiveness and repeated validation of safety measures."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "A Study of SGN-B6A Versus Docetaxel in Previously Treated Non-small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06012435.

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