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Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E/KEYMAKER-U01)

NCT ID: NCT06788912

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-20

Study Completion Date

2032-02-06

Brief Summary

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The main goals are after treatment given before surgery, to measure the number of people who have no signs of cancer cells in tumors and lymph nodes removed during surgery; and to learn about whether the cancer gets smaller or goes away by measuring the number of people with a certain number of living cancer cells in the tumor removed during surgery.

Related Clinical Trials

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KEYMAKER-U01 Substudy 2: Efficacy and Safety Study of Pembrolizumab (MK-3475) When Used With Investigational Agents in Treatment-naïve Participants With Anti-programmed Cell Death Receptor Ligand 1 (PD-L1) Positive Advanced Non-small Cell Lung Cancer (NSCLC) (MK-3475-01B/KEYMAKER-U01B)

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COMPLETED PHASE2

KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)

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COMPLETED PHASE2

Study of Pembrolizumab (MK-3475) in Participants With Advanced Non-small Cell Lung Cancer (MK-3475-025/KEYNOTE-025)

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Non-small Cell Lung Cancer
COMPLETED PHASE1

Detailed Description

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Conditions

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Lung Neoplasm Malignant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pembrolizumab + Platinum

Neoadjuvant: Prior to surgery pembrolizumab 200 mg every three weeks (Q3W) for 4 cycles (each cycle is 21 days); Cisplatin 75 mg/m\^2 Q3W with gemcitabine 1000 mg/m\^2 on Day 1 and Day 8 Q3W (squamous tumors), pemetrexed 500 mg/m\^2 Q3W (nonsquamous tumors), or paclitaxel 175 mg/m\^2 or 200 mg/m\^2 q3w (any histology) OR Carboplatin AUC 5 mg/mL• min or AUC 6 mg/mL• min with paclitaxel 175 mg/m\^2 or 200 mg/m\^2 Q3W (any histology), pemetrexed 500 mg/m\^2 Q3W (nonsquamous tumors), or gemcitabine 1000 mg/m\^2 on Day 1 and Day 8 Q3W (squamous tumors); followed by surgery.

Adjuvant: After surgery pembrolizumab 200 mg Q3W for 13 cycles (each cycle is 21 days).

Group Type ACTIVE_COMPARATOR

Pembrolizumab (neoadjuvant)

Intervention Type BIOLOGICAL

Before surgery neoadjuvant Pembrolizumab 200 mg by intravenous (IV) infusion on day 1 of each 21-day cycle for 4 cycles

Cisplatin

Intervention Type DRUG

Cisplatin 75 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles

Gemcitabine

Intervention Type DRUG

In squamous tumors Gemcitabine 1000 mg/m\^2 by IV infusion on day 1 and day 8 of each 21-day cycle for 4 cycles.

Pemetrexed

Intervention Type DRUG

In nonsquamous tumors Pemetrexed 500 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles

Carboplatin

Intervention Type DRUG

AUC 5 mg/mL min or AUC 6 mg/mL min by IV infusion on day 1 of each 21-day cycle for 4 cycles

Pembrolizumab (adjuvant)

Intervention Type BIOLOGICAL

After surgery adjuvant Pembrolizumab 200 mg by IV infusion on day 1 of each 21-day cycle for 13 cycles

Paclitaxel

Intervention Type DRUG

Paclitaxel 175 or 200 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles.

Pembrolizumab + Sacituzumab tirumotecan

Neoadjuvant: Prior to surgery pembrolizumab 200 mg Q3W for 4 cycles (each cycle is 21 days); sacituzumab tirumotecan 4 mg/kg Q2W for 6 cycles (each cycle is 14 days), followed by surgery.

Adjuvant: After surgery pembrolizumab 200 mg Q3W for 13 cycles (each cycle is 21 days). Optional adjuvant platinum-based doublet chemotherapy up to 4 cycles may be given at the investigator's discretion.

Group Type EXPERIMENTAL

Pembrolizumab (neoadjuvant)

Intervention Type BIOLOGICAL

Before surgery neoadjuvant Pembrolizumab 200 mg by intravenous (IV) infusion on day 1 of each 21-day cycle for 4 cycles

Cisplatin

Intervention Type DRUG

Cisplatin 75 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles

Gemcitabine

Intervention Type DRUG

In squamous tumors Gemcitabine 1000 mg/m\^2 by IV infusion on day 1 and day 8 of each 21-day cycle for 4 cycles.

Pemetrexed

Intervention Type DRUG

In nonsquamous tumors Pemetrexed 500 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles

Sacituzumab tirumotecan

Intervention Type DRUG

Sacituzumab tirumotecan 4 mg/kg by IV infusion on day 1 of each 14-day cycle for up to 6 cycles

H1 receptor antagonist

Intervention Type DRUG

Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label

H2 receptor antagonist

Intervention Type DRUG

Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label

Acetaminophen (or equivalent)

Intervention Type DRUG

Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label

Dexamethasone (or equivalent)

Intervention Type DRUG

Administered as rescue medication 8 -10 mg before Sacituzumab tirumotecan infusion per approved product label

Carboplatin

Intervention Type DRUG

AUC 5 mg/mL min or AUC 6 mg/mL min by IV infusion on day 1 of each 21-day cycle for 4 cycles

Pembrolizumab (adjuvant)

Intervention Type BIOLOGICAL

After surgery adjuvant Pembrolizumab 200 mg by IV infusion on day 1 of each 21-day cycle for 13 cycles

Paclitaxel

Intervention Type DRUG

Paclitaxel 175 or 200 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles.

Steroid mouthwash (dexamethasone or equivalent)

Intervention Type DRUG

Administered orally as rescue medication 2-5 mL 4 times daily

Interventions

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Pembrolizumab (neoadjuvant)

Before surgery neoadjuvant Pembrolizumab 200 mg by intravenous (IV) infusion on day 1 of each 21-day cycle for 4 cycles

Intervention Type BIOLOGICAL

Cisplatin

Cisplatin 75 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles

Intervention Type DRUG

Gemcitabine

In squamous tumors Gemcitabine 1000 mg/m\^2 by IV infusion on day 1 and day 8 of each 21-day cycle for 4 cycles.

Intervention Type DRUG

Pemetrexed

In nonsquamous tumors Pemetrexed 500 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles

Intervention Type DRUG

Sacituzumab tirumotecan

Sacituzumab tirumotecan 4 mg/kg by IV infusion on day 1 of each 14-day cycle for up to 6 cycles

Intervention Type DRUG

H1 receptor antagonist

Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label

Intervention Type DRUG

H2 receptor antagonist

Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label

Intervention Type DRUG

Acetaminophen (or equivalent)

Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label

Intervention Type DRUG

Dexamethasone (or equivalent)

Administered as rescue medication 8 -10 mg before Sacituzumab tirumotecan infusion per approved product label

Intervention Type DRUG

Carboplatin

AUC 5 mg/mL min or AUC 6 mg/mL min by IV infusion on day 1 of each 21-day cycle for 4 cycles

Intervention Type DRUG

Pembrolizumab (adjuvant)

After surgery adjuvant Pembrolizumab 200 mg by IV infusion on day 1 of each 21-day cycle for 13 cycles

Intervention Type BIOLOGICAL

Paclitaxel

Paclitaxel 175 or 200 mg/m\^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles.

Intervention Type DRUG

Steroid mouthwash (dexamethasone or equivalent)

Administered orally as rescue medication 2-5 mL 4 times daily

Intervention Type DRUG

Other Intervention Names

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KEYTRUDA® MK-3475 PLATINOL® GEMZAR® Alimta® MK-2870 SKB264 PARAPLATIN® KEYTRUDA® MK-3475

Eligibility Criteria

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Inclusion Criteria

* Has previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC)
* Able to undergo protocol therapy, including necessary surgery
* Confirmation that epidermal growth factor receptor (EGFR) -directed therapy is not indicated as primary therapy
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 as assessed within 10 days before initiation of study intervention.
* Is able to provide archival or newly obtained core/excisional biopsy of the primary lung tumor or lymph node metastasis.

Exclusion Criteria

* Has one of the following tumor locations/types: NSCLC involving the superior sulcus, large-cell neuro-endocrine cancer, mixed tumors containing small cell and non-small cell elements, or sarcomatoid tumor.
* Has Grade ≥2 peripheral neuropathy.
* Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing.
* Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).
* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.
* Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention
* Received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids.
* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.
* Known additional malignancy that is progressing or has required active treatment within the past 5 years.
* Severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
* Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid) is allowed.
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
* Active infection requiring systemic therapy.
* Hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or Hepatitis C virus (defined as detectable hepatitis C virus (HCV) ribonucleic acid (RNA) \[qualitative\]) infection.
* Known history of human immunodeficiency virus (HIV) infection.
* History of allogeneic tissue/solid organ transplant.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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MedStar Franklin Square Medical Center ( Site 0033)

Baltimore, Maryland, United States

Site Status RECRUITING

Centro de Estudios Clínicos SAGA ( Site 0162)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

FALP ( Site 0161)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

Bradfordhill ( Site 0160)

Santiago, Region M. de Santiago, Chile

Site Status RECRUITING

Alexandra General Hospital of Athens Oncology-Hematology Unit ( Site 0203)

Athens, Attica, Greece

Site Status RECRUITING

ATTIKON GENERAL UNIVERSITY HOSPITAL-Oncology ( Site 0202)

Athens, Attica, Greece

Site Status RECRUITING

Metropolitan Hospital-4th Oncology Dept ( Site 0201)

Athens, Attica, Greece

Site Status RECRUITING

University General Hospital of Heraklion ( Site 0200)

Heraklion, Irakleio, Greece

Site Status RECRUITING

Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 0062)

Győr, Győr-Moson-Sopron, Hungary

Site Status RECRUITING

Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 0061)

Szolnok, Jász-Nagykun-Szolnok, Hungary

Site Status RECRUITING

Országos Korányi Pulmonológiai Intézet ( Site 0060)

Budapest, , Hungary

Site Status RECRUITING

Azienda Ospedaliera Universitaria Careggi ( Site 0173)

Florence, Tuscany, Italy

Site Status RECRUITING

Ospedale San Raffaele. ( Site 0171)

Milan, , Italy

Site Status RECRUITING

Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175)

Milan, , Italy

Site Status RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0174)

Roma, , Italy

Site Status RECRUITING

Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 0153)

Poznan, Greater Poland Voivodeship, Poland

Site Status RECRUITING

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151)

Warsaw, Masovian Voivodeship, Poland

Site Status RECRUITING

Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)

Gdansk, Pomeranian Voivodeship, Poland

Site Status RECRUITING

Hospital Clínic de Barcelona ( Site 0092)

Barcelona, , Spain

Site Status RECRUITING

Hacettepe Universite Hastaneleri-oncology hospital ( Site 0700)

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

CNE CC of Oncology Hematol ( Site 0130)

Cherkasy, Cherkasy Oblast, Ukraine

Site Status RECRUITING

Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 0139)

Chernivtsi, Chernivetska Oblast, Ukraine

Site Status RECRUITING

CNCE Precarpathian Clinical Oncologic Center ( Site 0131)

Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine

Site Status RECRUITING

MNPE LTMU Multidisc. Clin. Hosp. of Emerg. and Intens. Care ( Site 0132)

Lviv, Lviv Oblast, Ukraine

Site Status RECRUITING

ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0460)

Rivne, Rivne Oblast, Ukraine

Site Status RECRUITING

Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 0135)

Vinnytsia, Vinnytsia Oblast, Ukraine

Site Status RECRUITING

Shalimov Institute of Surgery and Transplantation ( Site 0138)

Kyiv, , Ukraine

Site Status RECRUITING

Countries

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United States Chile Greece Hungary Italy Poland Spain Turkey (Türkiye) Ukraine

Central Contacts

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Toll Free Number

Role: CONTACT

[email protected]
1-888-577-8839

Facility Contacts

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Study Coordinator

Role: primary

888-577-8839

Study Coordinator

Role: primary

+56991612199

Study Coordinator

Role: primary

+56224205098

Study Coordinator

Role: primary

+56229490970

Study Coordinator

Role: primary

0030 2132142545

Study Coordinator

Role: primary

0030 2313301848

Study Coordinator

Role: primary

0030 2104807106

Study Coordinator

Role: primary

0030 2810392091

Study Coordinator

Role: primary

+3696507900

Study Coordinator

Role: primary

+3656503603

Study Coordinator

Role: primary

+3613913200

Study Coordinator

Role: primary

+393209225506

Study Coordinator

Role: primary

390223903829

Study Coordinator

Role: primary

390223902190

Study Coordinator

Role: primary

+390630154844

Study Coordinator

Role: primary

+48616654242

Study Coordinator

Role: primary

48225463066

Study Coordinator

Role: primary

+48 58 584 44 66

Study Coordinator

Role: primary

34 932275402

Study Coordinator

Role: primary

+903123052941

Study Coordinator

Role: primary

+38(0472)31-94-18

Study Coordinator

Role: primary

+380955077568

Study Coordinator

Role: primary

+380978411455

Study Coordinator

Role: primary

380977453295

Study Coordinator

Role: primary

380503802915

Study Coordinator

Role: primary

0988936318

Study Coordinator

Role: primary

093 33 33 911

Related Links

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https://www.merckclinicaltrials.com/

Merck Clinical Trials Information

Other Identifiers

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MK-3475-01E

Identifier Type: OTHER

Identifier Source: secondary_id

KEYMAKER-U01

Identifier Type: OTHER

Identifier Source: secondary_id

2023-509234-19-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1299-6753

Identifier Type: REGISTRY

Identifier Source: secondary_id

3475-01E

Identifier Type: -

Identifier Source: org_study_id

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