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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 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
~3150

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.

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor
4,027 Previous Clinical Trials
5,188,678 Total Patients Enrolled
GenmabLead Sponsor
71 Previous Clinical Trials
14,796 Total Patients Enrolled
BioNTech SEIndustry Sponsor
77 Previous Clinical Trials
115,740 Total Patients Enrolled

Media Library

GEN1046 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05117242 — Phase 2
Lung Cancer Research Study Groups: Arm B, Arm C, Arm A
Lung Cancer Clinical Trial 2023: GEN1046 Highlights & Side Effects. Trial Name: NCT05117242 — Phase 2
GEN1046 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05117242 — Phase 2
~31 spots leftby Dec 2025