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Pembrolizumab

Phase 2

Lung Cancer, Non-Small Cell | Small molecule | Oncology |GSK plc|Last Updated: Jun 15, 2026

Target and mechanism

Molecular targetPDCD1
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment351

FDA Designations

No designations recorded

Clinical trial landscape

Pembrolizumab · 1 trial · 1 indication

Phase 2 1
NCT05565378A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung CancerLung Cancer, Non-Small Cell
ACTIVE NOT_RECRUITING351 Analytics
PHASE2ACTIVE NOT_RECRUITING
A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer
Lung Cancer, Non-Small CellUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Up to 228 weeks
Number of Participants with TEAEs or SAEs leading to dose modifications or treatment discontinuation
Up to 228 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Pembrolizumab MonotherapyACTIVE_COMPARATORParticipants will be administered with pembrolizumab as monotherapy in a fixed dose.
Dostarlimab MonotherapyEXPERIMENTALParticipants will be administered with dostarlimab as monotherapy in a fixed dose.
Substudy 1AEXPERIMENTALParticipants will be administered with dostarlimab in a fixed dose followed by belrestotug in a fixed dose (Dose A).
Substudy 1BEXPERIMENTALParticipants will be administered with dostarlimab in a fixed dose followed by belrestotug in a fixed dose (Dose B).
Substudy 1CEXPERIMENTALParticipants will be administered with dostarlimab in a fixed dose followed by belrestotug in a fixed dose (Dose C).
Substudy 2AEXPERIMENTALParticipants will be administered with dostarlimab, fixed dose belrestotug, and fixed dose nelistotug

Interventions

NameTypeDescription
PembrolizumabDRUGPembrolizumab will be administered.
DostarlimabDRUGDostarlimab will be administered
BelrestotugDRUGBelrestotug will be administered.
NelistotugDRUGNelistotug will be administered.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites99

Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of locally advanced unresectable NSCLC not eligible for curative surgery and/or definitive radiotherapy with or without chemotherapy or metastatic NSCLC (squamous or non squamous) * No prior systemic therapy for their locally...

Countries:United StatesArgentinaBelgiumBrazilFinlandFranceGermanyGreeceHungaryItalyJapanMexicoNetherlandsPolandPortugalSouth AfricaSouth KoreaSpainThailandTurkey (Türkiye)United Arab EmiratesUnited Kingdom
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Recent Changes (Last 90 Days)

MEDIUMJun 16, 2026NCT05565378primaryCompletionDate: changed
MEDIUMJun 16, 2026NCT05565378primaryCompletionDate: changed
MEDIUMJun 16, 2026NCT05565378primaryCompletionDate: changed
MEDIUMJun 16, 2026NCT05565378primaryCompletionDate: changed

Frequently asked questions about Pembrolizumab

What is Pembrolizumab used for in Non-Small Cell Lung Cancer?

Pembrolizumab is an investigational small molecule being studied for the treatment of Non-Small Cell Lung Cancer. It is currently in Phase 2 clinical development, with an active trial evaluating it in previously untreated, advanced or metastatic Non-Small Cell Lung Cancer. Pembrolizumab is not yet approved for this indication.

What does Pembrolizumab target?

Pembrolizumab targets PDCD1, also known as programmed cell death protein 1, and acts as an inhibitor of this target. By inhibiting PDCD1, Pembrolizumab is designed to modulate the immune response in the context of Non-Small Cell Lung Cancer. This mechanism is being investigated in ongoing clinical trials.

Who is developing Pembrolizumab?

Pembrolizumab is being developed by GSK plc, a biopharmaceutical company listed on the stock exchange under the ticker symbol GSK. GSK is conducting clinical trials to evaluate Pembrolizumab for the treatment of Non-Small Cell Lung Cancer, with the drug currently in Phase 2 development.

What phase is Pembrolizumab in?

Pembrolizumab is currently in Phase 2 clinical development for Non-Small Cell Lung Cancer. It is an investigational drug and has not received FDA approval. The most advanced trial is a Phase 2 platform study, while another early-stage trial has been terminated.

What clinical trials is Pembrolizumab in?

Pembrolizumab is being studied in two clinical trials. The primary trial, NCT05565378, is a Phase 2 platform study of novel immunotherapy combinations in previously untreated, advanced or metastatic Non-Small Cell Lung Cancer, with 351 participants enrolled. A second trial, NCT06405230, was a Phase 1 study that has been terminated.

Is Pembrolizumab the same as Keytruda?

No, Pembrolizumab is not the same as Keytruda. Pembrolizumab is a small molecule inhibitor of PDCD1 being developed by GSK plc, while Keytruda is a different drug. Pembrolizumab is currently in Phase 2 clinical trials for Non-Small Cell Lung Cancer and is not FDA approved.