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Monoclonal Antibodies
Acasunlimab + Pembrolizumab for Lung Cancer
Phase 3
Recruiting
Research Sponsored by Genmab
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 7 days of Cycle 1 Day 1
Participant has histologically or cytologically confirmed metastatic NSCLC (stage IV)
Must not have
Participants with newly identified or known unstable or symptomatic central nervous system (CNS) metastases or history of carcinomatous meningitis
Prior treatment with docetaxel for NSCLC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial will compare the effectiveness and safety of acasunlimab plus pembrolizumab versus docetaxel in patients with a specific type of lung cancer who have previously been treated with
Who is the study for?
This trial is for people with PD-L1-positive metastatic non-small cell lung cancer who have already tried treatments with PD-1/PD-L1 inhibitors and platinum-based chemotherapy. It's not suitable for those who can't take docetaxel or have had certain previous treatments that the study excludes.
What is being tested?
The trial compares a new combination of drugs, Acasunlimab and Pembrolizumab, against the standard treatment, Docetaxel. Participants are randomly assigned to one of these treatments to see if the new combo is more effective.
What are the potential side effects?
Possible side effects include immune-related reactions like inflammation in various organs, infusion-related symptoms such as fever or chills, fatigue, hair loss from Docetaxel, and potential increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My lung cancer is confirmed to be at stage IV.
Select...
My cancer progressed after 1 treatment with PD-1/PD-L1 and platinum, or I've had up to 2 treatments in sequence.
Select...
My tumor shows positive PD-L1 expression.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have new or worsening brain metastases or a history of cancer in my brain's lining.
Select...
I have been treated with docetaxel for lung cancer.
Select...
I have not had treatments like 4-1BB agents, cancer vaccines, cell therapies, or experimental immunotherapies.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Survival (OS)
Secondary study objectives
Change From Baseline in Functional Assessment of Cancer Therapy Item GP5 (FACIT-GP5; Version 4) Score
Confirmed Overall Response Rate (ORR)
Duration of Response (DOR)
+3 moreAwards & 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: Arm AExperimental Treatment2 Interventions
Acasunlimab, 100 mg and pembrolizumab, 400 mg will be administered via intravenous (IV) infusion, once every 6 weeks (Q6W) (Cycle length=42 days).
Group II: Arm BActive Control1 Intervention
Docetaxel, 75 mg/m\^2 will be administered via IV infusion, once every 3 weeks (Q3W) (Cycle length=21 days).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~3130
Acasunlimab
2021
Completed Phase 1
~20
Find a Location
Who is running the clinical trial?
GenmabLead Sponsor
71 Previous Clinical Trials
14,112 Total Patients Enrolled
BioNTech SEIndustry Sponsor
77 Previous Clinical Trials
115,273 Total Patients Enrolled
Study OfficialStudy DirectorGenmab
19 Previous Clinical Trials
5,611 Total Patients Enrolled