What side effects are associated with this type of intervention?

Common treatments for Non-Small Cell Lung Cancer (NSCLC) include pembrolizumab, carboplatin, pemetrexed, atezolizumab, and nivolumab, often used in combination with chemotherapy. Known side effects of these treatments can include fatigue, nausea, increased liver function tests, neutropenia, febrile neutropenia, hypertension, rash, stomatitis, pneumonitis, and anemia. Severe adverse events such as pneumonia, acute kidney injury, and respiratory failure have also been reported. Immunotherapy agents like pembrolizumab and atezolizumab can cause immune-related side effects, including skin reactions and endocrine events.

What prior FDA approvals exist?

Several FDA-approved treatments for Non-Small Cell Lung Cancer (NSCLC) involve immunotherapy, particularly immune checkpoint inhibitors. Pembrolizumab, an anti-PD-1 antibody, has been approved for use in combination with chemotherapy for advanced NSCLC, showing improved overall survival (OS) and progression-free survival (PFS). Atezolizumab, an anti-PD-L1 antibody, has also been approved in combination with chemotherapy for nonsquamous NSCLC, demonstrating significant benefits in OS and PFS. Cemiplimab, another PD-1 inhibitor, has shown efficacy in patients with high PD-L1 expression. These treatments enhance the immune response against cancer cells, similar to the investigational approach of SEA-CD40 combined with other drugs.

What other types of research exist?

Promising alternatives to SEA-CD40 for NSCLC patients include pembrolizumab (a PD-1 inhibitor) combined with chemotherapy (carboplatin and pemetrexed), which has shown improved overall survival and progression-free survival in clinical trials. Another option is atezolizumab (a PD-L1 inhibitor) combined with chemotherapy, particularly for patients with high PD-L1 expression. These therapies have demonstrated significant clinical benefits and are considered effective treatment options for NSCLC.

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Alkylating agents

SEA-CD40 Combination Therapy for Non-Small Cell Lung Cancer

Phase 2

Waitlist Available

Research Sponsored by Seagen Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed unresectable malignancy defined as specified in each cohort

Be older than 18 years old

Must not have

Active central nervous system (CNS) metastases and/or carcinomatous meningitis

Previous exposure to CD40-targeted therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up duration of study, approximately 4 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called SEA-CD40 to see if it can help treat certain types of cancer when used with other medications. It targets patients with hard-to-treat melanoma and advanced lung cancer. The drug works by boosting the immune system and working with other drugs to attack cancer cells. This new treatment option has the potential to generate anticancer immunity through various mechanisms.

Who is the study for?

This trial is for adults with certain types of cancer, like melanoma that's returned or can't be surgically removed, and NSCLC that has spread. They must not have had CD40-targeted therapy before, no other cancers in the last 3 years, no autoimmune diseases treated in the past 2 years, and they shouldn't be on high doses of steroids or have active brain metastases.

What is being tested?

The study tests an experimental drug called SEA-CD40 combined with pembrolizumab for melanoma patients; and SEA-CD40 with pembrolizumab, carboplatin, and pemetrexed for those with advanced NSCLC. It aims to see if these combinations are effective against these cancers.

What are the potential side effects?

Possible side effects include immune system reactions leading to inflammation in various organs (like lungs or intestines), infusion-related reactions from the drugs being administered into a vein, fatigue from treatment burden on the body's energy resources, potential blood cell count changes affecting immunity and clotting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is confirmed by lab tests and cannot be removed by surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My cancer has spread to my brain or the protective layers of my brain.

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I have been treated with CD40-targeted therapy before.

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I am taking long-term steroid medication above normal replacement levels.

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I have been treated for an autoimmune disease in the last 2 years.

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I have received an organ or tissue transplant from another person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ duration of study, approximately 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~duration of study, approximately 4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of study, approximately 4 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)

Secondary study objectives

Disease control rate (DCR) per investigator assessment

Duration of response (DOR) per investigator assessment

Incidence of adverse events (AEs)

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: NSCLC ArmExperimental Treatment4 Interventions

SEA-CD40 + pembrolizumab + pemetrexed + carboplatin

Group II: Melanoma ArmExperimental Treatment2 Interventions

SEA-CD40 + pembrolizumab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

pemetrexed

2005

Completed Phase 3

~5000

carboplatin

2010

Completed Phase 3

~4790

0 / 6Eligibility 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 immunotherapy and chemotherapy. Immunotherapy drugs like pembrolizumab block the PD-1/PD-L1 pathway, enabling the immune system to recognize and attack cancer cells. Chemotherapy agents such as carboplatin and pemetrexed damage the DNA of cancer cells, inhibiting their growth and division. SEA-CD40, an experimental drug, targets CD40 to enhance the immune response by activating antigen-presenting cells. These mechanisms are vital for NSCLC patients as they inform treatment choices, aiming to improve efficacy and patient outcomes.

Immunotherapy for non-small-cell lung cancer: the past 10 years.Monoclonal antibodies in the treatment of lung cancer.