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Pembrolizumab infusion

Phase 2

Stage IIIB(N2) Non-small Cell Lung Cancer | Monoclonal antibody | Oncology |Merck & Company, Inc.|Last Updated: Jul 23, 2025

Target and mechanism

Molecular targetPDCD1
Target classInhibitor
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment70

FDA Designations

PRIORITY_REVIEW

Clinical trial landscape

Pembrolizumab infusion · 1 trial · 4 indications

Phase 2 1
NCT05894889Pembrolizumab and Chemotherapy Neoadjuvant/Adjuvant of NSCLCStage IIIB(N2) Non-small Cell Lung Cancer
ACTIVE NOT_RECRUITING70 Analytics
PHASE2ACTIVE NOT_RECRUITING
Pembrolizumab and Chemotherapy Neoadjuvant/Adjuvant of NSCLC
Stage IIIB(N2) Non-small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

pCR rate
Up to approximately 16 months

pCR in eligible stage IIA-IIIB (N2) NSCLC participants (AJCC Version 8, no known sensitizing EGFR or ALK alterations) following neoadjuvant pembrolizumab plus chemotherapy

Post-treatment proportion of CXCL13+PD1+ CD8 T cells in all CD8 T cells
Up to approximately 16 months

Post-treatment proportion of CXCL13+PD1+ CD8 T cells in all CD8 T cells in single cell RNA-seq data

Secondary Endpoints

MPR in eligible stage IIA-IIIB (N2) NSCLC participants (AJCC Version 8, no known sensitizing EGFR or ALK alterations) following neoadjuvant pembrolizumab plus chemotherapy
Up to approximately 16 months
Event-free survival (EFS)
Up to approximately 46 months
Number of Participants with One or More Adverse Events
Up to approximately 46 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Pembrolizumab + ChemotherapyEXPERIMENTALNon-squamous NSCLC: pembrolizumab 200mg as at least 30-minute IV infusion on Day 1, followed by pemetrexed at a dose of 500mg/m2 IV over 30 minutes or per institutional standard with Carboplatin at a dose of AUC 5 over 120 minutes or per institutional standard, of a 3-week treatment cycle, for up to 4 cycles. Squamous NSCLC: pembrolizumab 200mg as at least 30-minute IV infusion on Day 1, followed by nab-paclitaxel at a dose of 135mg/m2 IV over 30 minutes or per institutional standard with Carboplatin at a dose of AUC 5 over 120 minutes or per institutional standard, of a 3-week treatment cycle, for up to 4 cycles. Nab-paclitaxel will also be administered at the dose of 135mg/m2 for over 30 minutes IV infusion or per institutional standard on day 8 of each 3-week treatment cycle.

Interventions

NameTypeDescription
Pembrolizumab 200 mg IV infusionBIOLOGICALBiological: Pembrolizumab 200 mg IV infusion Drug: nab-paclitaxel IV infusion Drug: Carboplatin IV infusion Drug: Pemetrexed IV infusion
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: 1. Male/female participants who are at least 18 years of age on the day of signing informed consent with histologically confirmed diagnosis of \[Stage II, IIIA or IIIB(N2) NSCLC (AJCC Version 8)\] will be enrolled in this study. Note: mixed cellularity tumors are allowed. tu...

Countries:China
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Frequently asked questions about Pembrolizumab infusion

What is Pembrolizumab infusion used for in Stage IIIB(N2) Non-small Cell Lung Cancer?

Pembrolizumab infusion is used for the treatment of Stage IIIB(N2) Non-small Cell Lung Cancer. It is being studied in combination with chemotherapy as neoadjuvant and adjuvant therapy for this condition. The drug is a monoclonal antibody being developed by Merck & Company, Inc. for this oncology indication.

What does Pembrolizumab infusion target?

Pembrolizumab infusion is a monoclonal antibody that belongs to the -mab (antibody) target class. As an antibody-based therapy, it is designed to interact with specific molecular targets involved in cancer progression. The drug is being evaluated in a biomarker-selected patient population for Non-small Cell Lung Cancer.

Who makes Pembrolizumab infusion?

Pembrolizumab infusion is developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical research on this monoclonal antibody for the treatment of Stage IIIB(N2) Non-small Cell Lung Cancer and other related stages of the disease.

What phase is Pembrolizumab infusion in?

Pembrolizumab infusion is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug has received a Priority Review designation from the FDA, indicating it is being evaluated for expedited review, but it remains in active clinical testing.

What clinical trials is Pembrolizumab infusion in?

Pembrolizumab infusion is being studied in clinical trial NCT05894889, titled 'Pembrolizumab and Chemotherapy Neoadjuvant/Adjuvant of NSCLC'. This Phase 2 trial is active but not recruiting, with an enrollment of 70 participants. The trial is being conducted in China and includes patients with Stage IIIB(N2), Stage IIA, Stage IIB, and Stage IIIA Non-small Cell Lung Cancer.

Is Pembrolizumab infusion the same as Pembrolizumab 200 mg IV infusion?

Yes, Pembrolizumab infusion is also known as Pembrolizumab 200 mg IV infusion. Both names refer to the same drug product, which is administered as an intravenous infusion at a 200 mg dose. This naming is used in clinical and prescribing contexts for the monoclonal antibody therapy.