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M7824

Phase 3

Non-small Cell Lung Cancer | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Apr 8, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment304

FDA Designations

No designations recorded

Clinical trial landscape

M7824 · 1 trial · 1 indication

Phase 3 1
NCT03631706M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC)Non-small Cell Lung Cancer
COMPLETED304 Analytics
PHASE3COMPLETED
M7824 Versus Pembrolizumab as a First-line (1L) Treatment in Participants With Programmed Death-ligand 1 (PD-L1) Expressing Advanced Non-small Cell Lung Cancer (NSCLC)
Non-small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.1) Assessed by Independent Review Committee (IRC)
Time from randomization of study drug until the first documentation of PD or death, assessed approximately up to 746 days

Progression free survival was defined as the time from randomization of study intervention until the first documentation of disease progression (PD) or death due to any cause, whichever occurred first. PD: At least a 20 percent (%) increase in the sum of the longest diameter (SLD) taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Overall Survival (OS)
Time from randomization of study drug assessed approximately up to 843 days

Overall Survival was defined as the time from randomization of study intervention to the date of death due to any cause. The overall survival was analyzed by using the Kaplan-Meier method.

Secondary Endpoints

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related TEAEs According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0
Time from first treatment assessed up to approximately 843 days
Percentage of Participants With Unconfirmed Best Overall Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)
Time from randomization of study drug until the first documentation of PD or death, assessed approximately up to 746 days
Duration of Response (DOR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Independent Review Committee (IRC)
From first documented objective response to PD or death due to any cause, assessed approximately up to 746 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
M7824EXPERIMENTAL -
PembrolizumabACTIVE_COMPARATOR -

Interventions

NameTypeDescription
M7824DRUGParticipants received intravenous infusion of M7824 at a dose of 1200 milligrams (mg) once every 2 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
PembrolizumabDRUGPembrolizumab: Participants received intravenous infusion of Pembrolizumab at a dose of 200 milligrams (mg) once every 3 weeks until confirmed progression of disease, death, unacceptable toxicity, or study withdrawal.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites119

Inclusion Criteria: * Histologically confirmed diagnosis of advanced NSCLC * Have not received prior systemic therapy treatment for their advanced/Stage four NSCLC. Completion of treatment with cytotoxic chemotherapy, biological therapy, and/or radiation as part of neoadjuvant/adjuvant therapy is a...

Countries:United StatesArgentinaBelgiumBrazilCanadaChinaFranceGermanyGreeceHong KongItalyJapanNetherlandsSouth KoreaSpainTaiwanTurkey (Türkiye)Ukraine
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Competitive Landscape -Non-Small Cell Lung Cancer 389 trials

Frequently asked questions about M7824

What is M7824 used for in Non-small Cell Lung Cancer?

M7824 is an investigational small molecule being studied for the first-line treatment of advanced Non-small Cell Lung Cancer (NSCLC) in patients whose tumors express PD-L1. It is being compared against pembrolizumab in a Phase 3 clinical trial. M7824 is not yet approved and remains in clinical development.

What does M7824 target?

M7824 targets the PD-L1 pathway in the treatment of Non-small Cell Lung Cancer. The Phase 3 trial specifically enrolls participants with PD-L1 expressing advanced NSCLC, indicating that the drug's mechanism is directed at this biomarker. The drug is designed to interfere with PD-L1 signaling in tumor cells.

Who makes M7824?

M7824 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the stock exchange under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced Non-small Cell Lung Cancer.

What phase is M7824 in?

M7824 is in Phase 3 clinical development. It is being studied in a completed Phase 3 trial for the first-line treatment of advanced Non-small Cell Lung Cancer with PD-L1 expression. The drug is investigational and has not received FDA approval for any indication.

What clinical trials is M7824 in?

M7824 has one completed Phase 3 clinical trial registered under NCT03631706. This trial compared M7824 versus pembrolizumab as a first-line treatment in 304 participants with PD-L1 expressing advanced Non-small Cell Lung Cancer. The study was conducted across multiple countries including the United States, China, Japan, and several European nations.

Is M7824 the same as pembrolizumab?

No, M7824 is not the same as pembrolizumab. M7824 is an investigational small molecule being developed by Merck & Company, while pembrolizumab is an approved PD-1 inhibitor. In the Phase 3 trial NCT03631706, M7824 was directly compared against pembrolizumab as an active control in patients with advanced Non-small Cell Lung Cancer.