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PD-1 Inhibitor

M1774 + Cemiplimab for Advanced Lung Cancer

Phase 1 & 2
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
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
Must not have
Participant with history of (noninfectious) pneumonitis that required systemic corticosteroids or current pneumonitis/interstitial lung disease
Participants with history of additional malignancy within 3 years before the date of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had pneumonitis treated with steroids or currently have lung disease.
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I have had another type of cancer within the last 3 years.
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My cancer has specific changes in the EGFR or ALK genes.
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My brain metastases are stable.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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
~1470

Find a Location

Who is running the clinical trial?

EMD Serono Research & Development Institute, Inc.Lead Sponsor
83 Previous Clinical Trials
22,430 Total Patients Enrolled
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
443 Previous Clinical Trials
114,509 Total Patients Enrolled
Medical ResponsibleStudy DirectorMerck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
298 Previous Clinical Trials
60,864 Total Patients Enrolled

Media Library

Cemiplimab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05882734 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: Dosing Regimen 2 (Phase 1b): M1774 + Cemiplimab, Dosing Regimen 1 (Phase 1b): M1774 + Cemiplimab, Stratum A (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b, Stratum B (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b, Stratum C (Phase 2a): Either Dosing Regimen 1 or 2 as finalized in Phase 1b
Non-Small Cell Lung Cancer Clinical Trial 2023: Cemiplimab Highlights & Side Effects. Trial Name: NCT05882734 — Phase 1 & 2
Cemiplimab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05882734 — Phase 1 & 2
~29 spots leftby Nov 2025
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