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PD-1 Inhibitor
M1774 + Cemiplimab for Advanced Lung Cancer
Phase 1 & 2
Recruiting
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
Prior best overall response of stable disease or better with anti-PD-(L)1 therapy
Participants with Radiologically confirmed/documented disease progression during or after specific systemic therapies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time from randomization to final assessment at end of safety follow-up visit approximately up to 3 years and 2 months
Awards & highlights
Study Summary
This trial tests a new drug to treat advanced NSCLC after other treatments have failed. It will measure effectiveness, safety, and how the body absorbs the drug.
Who is the study for?
This trial is for adults with non-squamous Non-Small Cell Lung Cancer (nsqNSCLC) that worsened after anti-PD-(L)1 and platinum-based treatments. They must have shown some positive response to previous therapies, have measurable disease, be in good physical condition (ECOG PS 0 or 1), and have proper organ function. People with certain lung conditions, other cancers within the last three years, brain metastases, or specific genetic mutations are not eligible.Check my eligibility
What is being tested?
The study tests M1774 combined with Cemiplimab on patients whose nsqNSCLC has progressed despite prior treatments. It's an open-label trial meaning everyone knows what treatment they're getting. The goal is to see how well this combo works in terms of safety and effectiveness while also studying how the body processes these drugs.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system activation such as inflammation in various organs, skin issues, fatigue, changes in blood counts leading to increased infection risk or bleeding problems. Specific side effects from ATR inhibition could occur but are not detailed here.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My previous treatment with anti-PD-(L)1 therapy showed stable disease or improvement.
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My cancer has worsened despite treatment.
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My lung cancer is non-squamous and confirmed by lab tests.
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I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time from randomization to final assessment at end of safety follow-up visit approximately up to 3 years and 2 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time from randomization to final assessment at end of safety follow-up visit approximately up to 3 years and 2 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Phase 1b/Phase 2a: Confirmed Overall response (OR) According to Response Evaluation Criteria in Solid Tumor (RECIST) 1.1 As assessed by Investigator
Phase 1b: Number of Participants With Adverse Events (AEs) and Treatment-related AEs
Secondary outcome measures
Phase 1b/Phase 2a: Duration of Response (DoR) According to RECIST 1.1 as Assessed by the Investigator
Phase 1b/Phase 2a: Overall survival (OS)
Phase 1b/Phase 2a: Progression Free Survival (PFS) According to RECIST 1.1 as Assessed by the Investigator
+1 moreTrial Design
5Treatment groups
Experimental Treatment
Group I: Stratum C (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1bExperimental Treatment2 Interventions
Group II: Stratum B (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1bExperimental Treatment2 Interventions
Group III: Stratum A (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1bExperimental Treatment2 Interventions
Group IV: Dosing Regimen 2 (Phase 1b): M1774 + CemiplimabExperimental Treatment2 Interventions
Group V: Dosing Regimen 1 (Phase 1b): M1774 + CemiplimabExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cemiplimab
2015
Completed Phase 3
~1340
Find a Location
Who is running the clinical trial?
EMD Serono Research & Development Institute, Inc.Lead Sponsor
76 Previous Clinical Trials
30,680 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
436 Previous Clinical Trials
114,476 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
288 Previous Clinical Trials
68,795 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My tumor's genetic changes were analyzed using a certified liquid biopsy test.My previous treatment with anti-PD-(L)1 therapy showed stable disease or improvement.You have a disease that can be measured using specific medical guidelines.I have had pneumonitis treated with steroids or currently have lung disease.I have had another type of cancer within the last 3 years.My cancer has specific changes in the EGFR or ALK genes.My brain metastases are stable.My cancer has worsened despite treatment.My lung cancer is non-squamous and confirmed by lab tests.I am fully active or restricted in physically strenuous activity but can do light work.My blood, liver, and kidney functions meet the required levels.
Research Study Groups:
This trial has the following groups:- Group 1: Dosing Regimen 2 (Phase 1b): M1774 + Cemiplimab
- Group 2: Dosing Regimen 1 (Phase 1b): M1774 + Cemiplimab
- Group 3: Stratum A (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b
- Group 4: Stratum B (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b
- Group 5: Stratum C (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b
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.
Are there any opportunities for new participants in this experiment at present?
"The information on clinicaltrials.gov elucidates that this particular medical trial is not currently enrolling patients. It was initially posted on July 11th, 2023 and the most recent update occurred on May 22nd, 2023. Notwithstanding this news, there are an abundance of other trials recruiting now with a total of 2,090 opportunities available to those interested in participating in research studies."
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