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Monoclonal Antibodies
Avelumab for Non-Small Cell Lung Cancer
Phase 3
Waitlist Available
Research Sponsored by EMD Serono Research & Development Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female subjects aged greater than or equal to (>=) 18 years
With Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from date of randomization up to data cutoff (assessed up to 71.5 months)
Awards & highlights
Study Summary
This trial will compare the effectiveness of avelumab versus a platinum-based chemotherapy in treating patients with NSCLC.
Who is the study for?
This trial is for adults (18+) with Stage IV non-small cell lung cancer that hasn't been treated systemically. They need a recent tissue sample for PD-L1 testing, at least one measurable tumor lesion, and an ECOG Performance Status of 0-1. Exclusions include prior T-cell therapy, severe allergies to monoclonal antibodies, uncontrolled asthma, EGFR mutations or ALK rearrangement in their cancer, and certain brain metastases conditions.Check my eligibility
What is being tested?
The study tests the effectiveness of Avelumab against standard platinum-based chemotherapy drugs like Carboplatin and Cisplatin in improving survival rates without cancer progression in patients whose tumors express PD-L1. Patients are randomly assigned to receive either Avelumab or one of the chemotherapy options.See study design
What are the potential side effects?
Avelumab may cause immune-related side effects such as skin reactions, thyroid issues, inflammation of organs like lungs or intestines; infusion reactions; fatigue; nausea; and potential increased risk of infections. Chemotherapy can lead to hair loss, nerve damage, blood disorders and more.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You are 18 years old or older.
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You are in good enough health to perform everyday activities without much difficulty.
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You have at least one tumor that can be measured.
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You have been diagnosed with advanced or recurring non-small cell lung cancer.
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You have not received any treatment for lung cancer that has spread in the body, and your doctor thinks you will live for at least 12 more weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from date of randomization up to data cutoff (assessed up to 71.5 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from date of randomization up to data cutoff (assessed up to 71.5 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS)
Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS)
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS)
+1 moreSecondary outcome measures
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ HRQoL Analysis Set
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life (EORTC QLQ-C30) Global Health Status at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ Modified HRQoL Analysis Set
Change From Baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13) at End of Treatment (EOT) in High Programmed Death Ligand 1 (PD-L1)+ HRQoL Analysis Set
+25 moreSide effects data
From 2020 Phase 2 trial • 19 Patients • NCT0300684817%
Musculoskeletal and connective tissue disorders
11%
Injury, poisoning and procedural complications
6%
Immune system disorders
6%
General disorders and administration site conditions
6%
Nervous system disorders
6%
Investigations
6%
Infections and infestations
6%
Cardiac disorders
6%
Gastrointestinal disorders
6%
Metabolism and nutrition disorders
6%
Endocrine disorders
6%
Blood and lymphatic system disorders
6%
Neoplasms benign, malignant and unspecified
6%
Respiratory, thoracic and mediastinal disorders
6%
Renal and urinary disorders
6%
Skin and subcutaneous tissue disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Avelumab
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Avelumab WeeklyExperimental Treatment2 Interventions
Group II: Avelumab BiweeklyExperimental Treatment1 Intervention
Group III: ChemotherapyActive Control4 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Avelumab Weekly
2015
Completed Phase 3
~1220
Avelumab
2018
Completed Phase 2
~2450
Find a Location
Who is running the clinical trial?
EMD Serono Research & Development Institute, Inc.Lead Sponsor
76 Previous Clinical Trials
29,646 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
436 Previous Clinical Trials
113,442 Total Patients Enrolled
Medical ResponsibleStudy DirectorEMD Serono Inc., an affiliate of Merck KGaA, Darmstadt, Germany
288 Previous Clinical Trials
67,761 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to have a recent tissue sample or tumor slides available for testing PD-L1 expression.You have received treatment with drugs that target T cell proteins, are currently undergoing cancer treatment, or are taking medications that weaken the immune system.You have been diagnosed with advanced or recurring non-small cell lung cancer.You are 18 years old or older.You have not received any treatment for lung cancer that has spread in the body, and your doctor thinks you will live for at least 12 more weeks.You have had very serious allergic reactions to similar types of drugs in the past or have uncontrolled asthma.You cannot participate if your disease has specific changes in the EGFR or ALK genes.You have brain metastases, but they have been treated and are stable for at least 2 weeks before the study. You must not be taking high doses of steroids and should not have ongoing symptoms related to the brain metastases.You have at least one tumor that can be measured.You are in good enough health to perform everyday activities without much difficulty.
Research Study Groups:
This trial has the following groups:- Group 1: Avelumab Biweekly
- Group 2: Avelumab Weekly
- Group 3: Chemotherapy
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
What are some of the possible risks associated with Avelumab?
"Avelumab is safe according to our 3-point scale at Power because it has received support in multiple rounds of Phase 3 trials."
Answered by AI
Is there still room for new participants in this research project?
"Unfortunately, this clinical trial is not currently seeking new participants. Although, it's worth noting that the study was first posted on October 29th, 2015 and edited as recently as May 25th, 2022. For individuals interested in other studies, there are 1,391 trials for first line non-small cell lung cancer and 1,869 Avelumab studies looking for patients right now."
Answered by AI
What prior research has there been with Avelumab?
"Avelumab was first studied in the year 1997 at City of Hope Comprehensive Cancer Center and, since then, there have been a total of 2911 completed trials. Out of these 1869 are actively recruiting clinical trials with many being conducted out of Shreveport, Louisiana."
Answered by AI
How many people are included in the research project?
"Unfortunately, this particular trial is not currently looking for new participants. Although, it's worth mentioning that there are 1391 trials for first line non-small cell lung cancer and 1869 studies involving Avelumab that are actively recruiting patients."
Answered by AI
For what purpose is Avelumab most often prescribed?
"Avelumab is an immunotherapy medication that can be used to treat metastatic ureter urothelial carcinoma, lymphoma, non-hodgkin, and locally advanced non-small cell lung cancer."
Answered by AI
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