What side effects are associated with this type of intervention?

Common treatments for NSCLC, particularly those involving immunotherapies like checkpoint inhibitors (e.g., pembrolizumab, nivolumab) and combination therapies with chemotherapy, often result in a range of side effects. These can include immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and skin reactions. Chemotherapy-related side effects frequently include neutropenia, febrile neutropenia, anemia, thrombocytopenia, nausea, vomiting, and fatigue. Dual targeting therapies, like Acasunlimab, may also lead to enhanced immune activation, potentially increasing the risk of autoimmune reactions and other immune-related toxicities.

What prior FDA approvals exist?

The FDA has approved several immunotherapies for the treatment of Non-Small Cell Lung Cancer (NSCLC), particularly those targeting the PD-1/PD-L1 pathways. Pembrolizumab, an anti-PD-1 antibody, has been approved both as monotherapy and in combination with chemotherapy for advanced NSCLC, showing significant improvements in overall survival and progression-free survival. Nivolumab, another anti-PD-1 antibody, has been approved for use after progression on platinum-based chemotherapy. Additionally, the combination of nivolumab and ipilimumab, an anti-CTLA-4 antibody, has been approved for first-line treatment of metastatic NSCLC. Atezolizumab, an anti-PD-L1 antibody, has also been approved in combination with chemotherapy for both squamous and non-squamous NSCLC. These approvals highlight the effectiveness of targeting immune checkpoints in the treatment of NSCLC.

What other types of research exist?

Promising novel alternatives to Acasunlimab for NSCLC patients include: 1) Pembrolizumab, which has shown long-term efficacy in NSCLC with brain metastases. 2) Nivolumab, effective in both squamous and non-squamous NSCLC, including those with brain metastases. 3) Atezolizumab, particularly in combination with chemotherapy for non-squamous NSCLC. 4) Lorlatinib, for ALK-positive NSCLC with brain metastases. 5) Alectinib, effective against systemic disease and brain metastases in ALK-rearranged NSCLC. 6) Osimertinib, which improves overall survival in EGFR-mutated NSCLC with leptomeningeal metastases.

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Monoclonal Antibodies

Acasunlimab + Pembrolizumab for Lung Cancer

Phase 2

Waitlist Available

Research Sponsored by Genmab

Eligibility Criteria Checklist

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

Must have

Be at least 18 years of age

Have histologically or cytologically confirmed diagnosis of stage 4 NSCLC with at least 1 prior line of systemic therapy containing an anti-PD-1/PD-L1 mAb for metastatic disease

Must not have

Any investigational agent for the treatment of stage 4 NSCLC

Symptomatic congestive heart failure (grade III or IV as classified by the New York Heart Association), unstable angina pectoris, or cardiac arrhythmia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first treatment to date of death (assessed up to 3 years after the last participant's first dose in the trial)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called acasunlimab, alone and with pembrolizumab, in patients with non-small cell lung cancer who did not improve with standard treatments. The drugs aim to help the immune system fight cancer more effectively.

Who is the study for?

Adults with stage 4 non-small cell lung cancer who've had prior treatment including anti-PD-1/PD-L1 antibodies can join this trial. They should be relatively active (ECOG ≤1), have a life expectancy of at least 3 months, and tumors expressing PD-L1 in ≥1% of cells. Excluded are those with recent radiation or immunotherapy side effects, severe heart conditions, uncontrolled hypertension, certain genetic mutations unless previously treated for them, significant autoimmune disease risk, liver disease, organ transplants within the last 3 months or known allergies to trial drugs.

What is being tested?

The trial is testing acasunlimab alone and combined with pembrolizumab in patients whose lung cancer has worsened after standard care. It aims to see how safe these treatments are and how well they work against the cancer.

What are the potential side effects?

Possible side effects include immune-related reactions that could affect organs like lungs or intestines (pneumonitis/colitis), skin issues (rash), hormone gland problems (thyroid disorders), fatigue, infusion reactions from the drug entering the body and potential allergic responses.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have stage 4 NSCLC and was treated with an anti-PD-1/PD-L1 drug.

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I am fully active and can carry on all pre-disease activities without restriction.

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My tumor shows PD-L1 expression in at least 1% of cells.

Exclusion Criteria

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

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I have not used experimental drugs for stage 4 lung cancer.

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I do not have severe heart failure, unstable chest pain, or irregular heartbeats.

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I haven't taken high doses of steroids like prednisone before starting the trial.

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I cannot use pembrolizumab due to health reasons.

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My blood pressure is very high despite taking medication.

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I have had severe side effects from immunotherapy, certain autoimmune diseases, liver disease, an organ or bone marrow transplant recently, or severe allergies to similar treatments.

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I have an autoimmune disease treated with immunosuppressants in the last 6 months.

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I have not received IV anti-infectives in the last 2 weeks.

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I have had lung inflammation that needed steroids or currently have it.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first treatment to date of death (assessed up to 3 years after the last participant's first dose in the trial)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first treatment to date of death (assessed up to 3 years after the last participant's first dose in the trial)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first treatment to date of death (assessed up to 3 years after the last participant's first dose in the trial) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective response rate (ORR)

Secondary study objectives

Duration of response (DOR)

Incidence and severity of adverse events (AEs) and laboratory abnormalities

Overall survival (OS)

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Arm CExperimental Treatment2 Interventions

Treatment with acasunlimab + pembrolizumab once every 42 days

Group II: Arm BExperimental Treatment2 Interventions

Treatment with acasunlimab + pembrolizumab once every 21 days

Group III: Arm AExperimental Treatment1 Intervention

Treatment with acasunlimab once every 21 days for the first 2 cycles and then every 42 days in subsequent cycles

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acasunlimab

2021

Completed Phase 1

~20

Pembrolizumab

2017

Completed Phase 3

~3130

0 / 13Eligibility 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 immunotherapies and targeted therapies. Immunotherapies like pembrolizumab and atezolizumab inhibit the PD-1/PD-L1 pathway, enabling the immune system to recognize and attack cancer cells. Targeted therapies, such as EGFR inhibitors (osimertinib) and ALK inhibitors (crizotinib), focus on specific genetic mutations that drive cancer growth. The investigational drug Acasunlimab targets both PD-L1 and 4-1BB to stimulate a stronger anti-tumor immune response. Understanding these mechanisms is vital for NSCLC patients as it allows for personalized treatment plans that can lead to better outcomes based on the unique characteristics of their tumors.

Emerging therapeutic agents for lung cancer.