What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include Antibody Drug Conjugates (ADCs) like Sigvotatug Vedotin, chemotherapy, and immunotherapy. ADCs can cause side effects such as fatigue, nausea, and increased liver function tests. Chemotherapy agents like docetaxel often lead to neutropenia, febrile neutropenia, and gastrointestinal issues. Immunotherapy drugs, such as pembrolizumab and atezolizumab, are associated with immune-related toxicities including pneumonitis, rash, and colitis. Each treatment has a unique side effect profile, and the severity can vary among patients.

What prior FDA approvals exist?

Several treatments have been FDA-approved for Non-Small Cell Lung Cancer (NSCLC), including targeted therapies and immunotherapies. Notably, antibody-drug conjugates (ADCs) like trastuzumab deruxtecan have been approved for NSCLC with specific genetic mutations such as HER2. Additionally, immunotherapies like pembrolizumab and atezolizumab, often combined with chemotherapy, have shown significant efficacy in improving overall survival and progression-free survival in various subtypes of NSCLC. These treatments, similar to Sigvotatug Vedotin, aim to target and kill cancer cells more effectively while minimizing damage to normal cells.

What other types of research exist?

Promising novel alternatives to Sigvotatug Vedotin for NSCLC patients include: 1) Pembrolizumab (Keytruda), an immune checkpoint inhibitor targeting PD-1, which has shown efficacy in previously treated NSCLC patients. 2) Nivolumab (Opdivo), another PD-1 inhibitor, often used in combination with ipilimumab (Yervoy) for enhanced efficacy. 3) Atezolizumab (Tecentriq), a PD-L1 inhibitor, which has been effective in various NSCLC settings. 4) Targeted therapies like osimertinib (Tagrisso) for patients with EGFR mutations or crizotinib (Xalkori) for ALK-positive NSCLC. These alternatives offer different mechanisms of action and have shown promising results in clinical trials.

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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 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

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

Musculoskeletal pain

Headache

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

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

0 / 15Eligibility criteria met

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.