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Monoclonal Antibodies
Acasunlimab + Pembrolizumab for Lung Cancer
Phase 2
Recruiting
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
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
Study Summary
This trial is testing a new drug, GEN1046, to see if it is safe and effective in treating patients with non-small cell lung cancer who have progressed after previous treatment.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
Select...
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.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective response rate (ORR)
Secondary outcome measures
Duration of response (DOR)
Incidence and severity of adverse events (AEs) and laboratory abnormalities
Overall survival (OS)
+2 moreTrial 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
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
3,888 Previous Clinical Trials
5,054,844 Total Patients Enrolled
GenmabLead Sponsor
56 Previous Clinical Trials
12,072 Total Patients Enrolled
BioNTech SEIndustry Sponsor
64 Previous Clinical Trials
107,521 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not used experimental drugs for stage 4 lung cancer.I do not have severe heart failure, unstable chest pain, or irregular heartbeats.I am 18 years old or older.I have stage 4 NSCLC and was treated with an anti-PD-1/PD-L1 drug.I haven't taken high doses of steroids like prednisone before starting the trial.I cannot use pembrolizumab due to health reasons.My organs and bone marrow are functioning well.You are expected to live for at least 3 more months.My blood pressure is very high despite taking medication.I haven't had recent radiotherapy or lung radiation over 30 Gy in the past 6 months, and I've recovered from any side effects.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.I have an autoimmune disease treated with immunosuppressants in the last 6 months.My cancer has specific genetic changes and I may have had targeted therapy for them.I have not received IV anti-infectives in the last 2 weeks.You have a disease that can be measured using specific guidelines.I have had lung inflammation that needed steroids or currently have it.I haven't taken any cancer drugs in the last 28 days.I am fully active and can carry on all pre-disease activities without restriction.You have a severe allergic reaction (Grade 3 or higher) to pembrolizumab or any of its ingredients.My tumor shows PD-L1 expression in at least 1% of cells.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B
- Group 2: Arm C
- Group 3: Arm A
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has GEN1046 received regulatory clearance from the FDA?
"Our assessment of GEN1046's safety was a score of 2, as this is only at the Phase 2 trial stage. While there are some preliminary data points endorsing its security, no assessments have been made regarding efficacy yet."
Answered by AI
Have any previous investigations focused on GEN1046?
"GEN1046 was initially studied in 2010 at City of Hope. There are 251 concluded trials, and 961 clinical trials that presently require participants with many located in Southfield, California."
Answered by AI
In what areas are the research activities of this project taking place?
"This clinical trial is recruiting participants from a total of 6 different medical sites, such as Ascension Providence Hospital in Southfield and Cancer & Hematology Centers of Western Michigan CHCWM P.C. in Grand Rapids, amongst other locations."
Answered by AI
For what indications is GEN1046 typically recommended by physicians?
"Generally, GEN1046 is prescribed to combat the spread of malignant tumors. It can also be beneficial in cases such as advanced melanoma, microsatellite instability high, and following chemotherapy failure."
Answered by AI
Are there currently any opportunities for patients to join the experiment?
"According to information available on clinicaltrials.gov, this investigation is still searching for suitable participants with the most recent update occurring on October 31st 2022. This research project was first opened up for recruitment purposes on October 27th 2021."
Answered by AI
What is the current enrolment size for this experiment?
"160 suitable candidates are needed to partake in this trial, which can be conducted at two different locations: Oncology Clinical Trials Ascension Providence Hospital located in Southfield, California and St. Joseph Heritage Healthcare based in Santa Rosa, Florida."
Answered by AI
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