Lung Neoplasm MalignantPhase 2NCT06788912
Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E/KEYMAKER-U01)
A Phase 2 study testing Pembrolizumab (neoadjuvant), Cisplatin and Gemcitabine in people with Lung Neoplasm Malignant, run by Merck Sharp & Dohme LLC at 39 sites in 9 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasm Malignant
- What is being tested?
- Pembrolizumab (neoadjuvant), Cisplatin and Gemcitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 39 sitesin 9 countries
- Study dates
- 20 Mar 2025to 6 Feb 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
39 sites in 9 countries.
39 sites in 9 countries
United States9 sites
Texas Oncology - Central/South Texas ( Site 8009)
Austin, Texas, 78705
Greenebaum Comprehensive Cancer Center ( Site 0402)
Baltimore, Maryland, 21201
MedStar Franklin Square Medical Center ( Site 0033)
Baltimore, Maryland, 21237
Southern Cancer Center (SCC) ( Site 8004)
Daphne, Alabama, 36526
Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8006)
Eugene, Oregon, 97401
Virginia Cancer Specialists (VCS) ( Site 8002)
Fairfax, Virginia, 22031
Rocky Mountain Cancer Centers (RMCC) ( Site 8011)
Lone Tree, Colorado, 80124
Sansum Clinic (Ridley Tree) ( Site 8012)
Santa Barbara, California, 93105
Texas Oncology - Northeast Texas ( Site 8005)
Tyler, Texas, 75702
Ukraine7 sites
CNE CC of Oncology Hematol ( Site 0130)
Cherkasy, Cherkasy Oblast, 18009
Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 0139)
Chernivtsi, Chernivetska Oblast, 58013
CNCE Precarpathian Clinical Oncologic Center ( Site 0131)
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018
Shalimov Institute of Surgery and Transplantation ( Site 0138)
Kyiv, 03126
MNPE LTMU Multidisc. Clin. Hosp. of Emerg. and Intens. Care ( Site 0132)
Lviv, Lviv Oblast, 79059
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0460)
Rivne, Rivne Oblast, 33010
Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 0135)
Vinnytsia, Vinnytsia Oblast, 21029
Turkey (Türkiye)5 sites
Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 0702)
Adana, 01250
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0700)
Ankara, 06230
Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 0704)
Antalya, 07059
İzmir Suat Seren Chest Disease Training & Research Hospital ( Site 0701)
Izmir, 35110
Ondokuz Mayıs Universitesi-Oncology department ( Site 0706)
Samsun, 55139
Greece4 sites
Alexandra General Hospital of Athens Oncology-Hematology Unit ( Site 0203)
Athens, Attica, 115 28
ATTIKON GENERAL UNIVERSITY HOSPITAL-Oncology ( Site 0202)
Athens, Attica, 12462
Metropolitan Hospital-4th Oncology Dept ( Site 0201)
Athens, Attica, 185 47
University General Hospital of Heraklion ( Site 0200)
Heraklion, Irakleio, 71110
Italy4 sites
Azienda Ospedaliera Universitaria Careggi ( Site 0173)
Florence, Tuscany, 50134
Ospedale San Raffaele. ( Site 0171)
Milan, 20132
Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175)
Milan, 20133
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0174)
Roma, 00168
Chile3 sites
Centro de Estudios Clínicos SAGA ( Site 0162)
Santiago, Region M. de Santiago, 7500653
FALP ( Site 0161)
Santiago, Region M. de Santiago, 7500921
Bradfordhill ( Site 0160)
Santiago, Region M. de Santiago, 8420383
Hungary3 sites
Országos Korányi Pulmonológiai Intézet ( Site 0060)
Budapest, 1121
Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 0062)
Győr, Győr-Moson-Sopron, 9024
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 0061)
Szolnok, Jász-Nagykun-Szolnok, 5000
Poland3 sites
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)
Gdansk, Pomeranian Voivodeship, 80-952
Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 0153)
Poznan, Greater Poland Voivodeship, 60-569
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151)
Warsaw, Masovian Voivodeship, 02-781
About this study
Official title: KEYMAKER-U01 Substudy 01E: A Phase 2 Umbrella Study With Rolling Arms of Investigational Agents With or Without Chemotherapy in Combination With Pembrolizumab in Treatment of Participants With Newly Diagnosed Resectable Stages II-IIIB (N2) Non-small Cell Lung Cancer (NSCLC)
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.
- Conditions
- Lung Neoplasm Malignant
- Being tested
- Pembrolizumab (neoadjuvant), Cisplatin, Gemcitabine, Pemetrexed, Sacituzumab tirumotecan
- Keywords
- Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1(PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
- Medical subject headings
- Lung Neoplasms, Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pembrolizumab (neoadjuvant)Biological
Also called KEYTRUDA®, MK-3475
Before surgery neoadjuvant Pembrolizumab 200 mg by intravenous (IV) infusion on day 1 of each 21-day cycle for 4 cycles
CisplatinDrug
Also called PLATINOL®
Cisplatin 75 mg/m^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles
GemcitabineDrug
Also called GEMZAR®
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.
PemetrexedDrug
Also called Alimta®
In nonsquamous tumors Pemetrexed 500 mg/m^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles
Sacituzumab tirumotecanDrug
Also called MK-2870, SKB264
Sacituzumab tirumotecan 4 mg/kg by IV infusion on day 1 of each 14-day cycle for up to 6 cycles
H1 receptor antagonistDrug
Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label
H2 receptor antagonistDrug
Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label
Acetaminophen (or equivalent)Drug
Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label
Dexamethasone (or equivalent)Drug
Administered as rescue medication 8 -10 mg before Sacituzumab tirumotecan infusion per approved product label
CarboplatinDrug
Also called PARAPLATIN®
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)Biological
Also called KEYTRUDA®, MK-3475
After surgery adjuvant Pembrolizumab 200 mg by IV infusion on day 1 of each 21-day cycle for 13 cycles
PaclitaxelDrug
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)Drug
Administered orally as rescue medication 2-5 mL 4 times daily
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab + Platinum | Active comparator | 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). Receives: Biological: Pembrolizumab (neoadjuvant); Drug: Cisplatin; Drug: Gemcitabine; Drug: Pemetrexed; Drug: Carboplatin; Biological: Pembrolizumab (adjuvant); Drug: Paclitaxel |
| Pembrolizumab + Sacituzumab tirumotecan | Experimental | 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. Receives: Biological: Pembrolizumab (neoadjuvant); Drug: Cisplatin; Drug: Gemcitabine; Drug: Pemetrexed; Drug: Sacituzumab tirumotecan; Drug: H1 receptor antagonist; Drug: H2 receptor antagonist; Drug: Acetaminophen (or equivalent); Drug: Dexamethasone (or equivalent); Drug: Carboplatin; Biological: Pembrolizumab (adjuvant); Drug: Paclitaxel; Drug: Steroid mouthwash (dexamethasone or equivalent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response (pCR)
pCR is defined as absence of residual viable invasive cancer on hematoxylin- and eosin-stained slides of the resected lung specimen and lymph nodes.
Measured: Up to approximately 20 weeks
Percent Residual Viable Tumor (%RVT)
%RVT is defined as the percentage of residual tumor estimated by comparing the estimated cross-sectional area of viable tumor with estimated cross-sectional areas of remainder of tumor bed. The tumor bed is defined as the area of tissue occupied by viable tumor or tumoral regression (includes areas of necrosis, foamy macrophages, giant cell reaction, cholesterol cleft granuloma, and inflammation.)
Measured: Up to approximately 20 weeks
Secondary outcomes (11)
Percentage of Participants Who Report at Least 1 Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Measured: Up to approximately 5 years
Percentage of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
Measured: Up to approximately 1 year
Event-free Survival (EFS)
EFS is defined as the time from randomization to any of the following events: radiographic disease progression per Response Evaluation Criteria In Solid Tumors 1.1 (RECIST 1.1) (for participants who have not had or will not have surgery, or participants who have gross residual disease after an incomplete resection [R2 resection]); local progression (primary tumor or regional lymph nodes) or distant metastasis precluding planned surgery; tumor determined to be unresectable in the operating room; local or distant recurrence (for participants who are disease free after surgery or participants with microscopic positive margins [R1 resection]); occurrence of new primary NCSLC; death due to any cause.
Measured: Up to approximately 5 years
Overall Survival (OS)
OS is defined as the time from randomization to death due to any cause.
Measured: Up to approximately 5 years
Distant Metastasis-Free Survival (DMFS)
DMFS is defined as the time from randomization to the date of diagnosis of distant metastasis or death, whichever occurs first.
Measured: Up to approximately 5 years
Objective Response Rate (ORR)
OR is defined as a complete response or partial response with or without confirmation per RECIST 1.1 as assessed by the investigator during the Neoadjuvant Phase.
Measured: Up to approximately 12 weeks
Percentage of Participants Who Experience a Perioperative Complication
Perioperative Complications include both intraoperative and postoperative complications.
Measured: Up to approximately 20 weeks
Mean Length of Hospital Stay
Hospital Stay is the length of inpatient time spent in hospital.
Measured: Up to approximately 20 weeks
Percentage of Participants Who Require Hospital Readmission after Discharge
In participants previously discharged from hospital, the percentage requiring readmission to hospital.
Measured: Up to approximately 20 weeks
Mean Length of Surgery
Length of surgery is the time spent in surgery.
Measured: Up to approximately 20 weeks
Percentage of Participants Who Require a Blood Transfusion
Blood transfusion is the transfer of donated blood into the vein of a recipient.
Measured: Up to approximately 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start20 Mar 2025
- Primary completion6 Feb 2032 (estimated)
- Study completion6 Feb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Neoplasm MalignantStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06788912
- Sponsor's protocol ID
- 3475-01E
- Other IDs
- MK-3475-01E, KEYMAKER-U01, 2023-509234-19-00, U1111-1299-6753, 2023
- Status last verified
- Oct 2026
- First submitted
- 17 Jan 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KEYMAKER-U01 Substudy 01E: A Phase 2 Umbrella Study With Rolling Arms of Investigational Agents With or Without Chemotherapy in Combination With Pembrolizumab in Treatment of Participants With Newly Diagnosed Resectable Stages II-IIIB (N2) Non-small Cell Lung Cancer (NSCLC)
- ClinicalTrials.gov ID
- NCT06788912
- Acronym / sponsor ID
- 3475-01E
- Conditions
- Lung Neoplasm Malignant
- Keywords
- Programmed Cell Death-1 (PD1, PD-1), Programmed Cell Death 1 Ligand 1(PDL1, PD-L1), Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2025 (actual)
- Primary completion
- 6 Feb 2032 (estimated)
- Study completion
- 6 Feb 2032 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab + Platinum | Active comparator | Biological: Pembrolizumab (neoadjuvant), Drug: Cisplatin, Drug: Gemcitabine, Drug: Pemetrexed, Drug: Carboplatin, Biological: Pembrolizumab (adjuvant), Drug: PaclitaxelNeoadjuvant: 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). |
| Pembrolizumab + Sacituzumab tirumotecan | Experimental | Biological: Pembrolizumab (neoadjuvant), Drug: Cisplatin, Drug: Gemcitabine, Drug: Pemetrexed, Drug: Sacituzumab tirumotecan, Drug: H1 receptor antagonist, Drug: H2 receptor antagonist, Drug: Acetaminophen (or equivalent), Drug: Dexamethasone (or equivalent), Drug: Carboplatin, Biological: Pembrolizumab (adjuvant), Drug: Paclitaxel, Drug: Steroid mouthwash (dexamethasone or equivalent)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pembrolizumab (neoadjuvant)Also: KEYTRUDA®, MK-3475Before surgery neoadjuvant Pembrolizumab 200 mg by intravenous (IV) infusion on day 1 of each 21-day cycle for 4 cycles | Biological | Pembrolizumab + Platinum, Pembrolizumab + Sacituzumab tirumotecan |
| CisplatinAlso: PLATINOL®Cisplatin 75 mg/m^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles | Drug | Pembrolizumab + Platinum, Pembrolizumab + Sacituzumab tirumotecan |
| GemcitabineAlso: GEMZAR®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. | Drug | Pembrolizumab + Platinum, Pembrolizumab + Sacituzumab tirumotecan |
| PemetrexedAlso: Alimta®In nonsquamous tumors Pemetrexed 500 mg/m^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles | Drug | Pembrolizumab + Platinum, Pembrolizumab + Sacituzumab tirumotecan |
| Sacituzumab tirumotecanAlso: MK-2870, SKB264Sacituzumab tirumotecan 4 mg/kg by IV infusion on day 1 of each 14-day cycle for up to 6 cycles | Drug | Pembrolizumab + Sacituzumab tirumotecan |
| H1 receptor antagonistAdministered as rescue medication before Sacituzumab tirumotecan infusion per approved product label | Drug | Pembrolizumab + Sacituzumab tirumotecan |
| H2 receptor antagonistAdministered as rescue medication before Sacituzumab tirumotecan infusion per approved product label | Drug | Pembrolizumab + Sacituzumab tirumotecan |
| Acetaminophen (or equivalent)Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label | Drug | Pembrolizumab + Sacituzumab tirumotecan |
| Dexamethasone (or equivalent)Administered as rescue medication 8 -10 mg before Sacituzumab tirumotecan infusion per approved product label | Drug | Pembrolizumab + Sacituzumab tirumotecan |
| CarboplatinAlso: PARAPLATIN®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 | Drug | Pembrolizumab + Platinum, Pembrolizumab + Sacituzumab tirumotecan |
| Pembrolizumab (adjuvant)Also: KEYTRUDA®, MK-3475After surgery adjuvant Pembrolizumab 200 mg by IV infusion on day 1 of each 21-day cycle for 13 cycles | Biological | Pembrolizumab + Platinum, Pembrolizumab + Sacituzumab tirumotecan |
| PaclitaxelPaclitaxel 175 or 200 mg/m^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles. | Drug | Pembrolizumab + Platinum, Pembrolizumab + Sacituzumab tirumotecan |
| Steroid mouthwash (dexamethasone or equivalent)Administered orally as rescue medication 2-5 mL 4 times daily | Drug | Pembrolizumab + Sacituzumab tirumotecan |
Primary outcome
Pathological Complete Response (pCR)
Time frame: Up to approximately 20 weeks
pCR is defined as absence of residual viable invasive cancer on hematoxylin- and eosin-stained slides of the resected lung specimen and lymph nodes.
Percent Residual Viable Tumor (%RVT)
Time frame: Up to approximately 20 weeks
%RVT is defined as the percentage of residual tumor estimated by comparing the estimated cross-sectional area of viable tumor with estimated cross-sectional areas of remainder of tumor bed. The tumor bed is defined as the area of tissue occupied by viable tumor or tumoral regression (includes areas of necrosis, foamy macrophages, giant cell reaction, cholesterol cleft granuloma, and inflammation.)
11 secondary outcomes
Percentage of Participants Who Report at Least 1 Adverse Event (AE)
Time frame: Up to approximately 5 years
Percentage of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 1 year
Event-free Survival (EFS)
Time frame: Up to approximately 5 years
Overall Survival (OS)
Time frame: Up to approximately 5 years
Distant Metastasis-Free Survival (DMFS)
Time frame: Up to approximately 5 years
Objective Response Rate (ORR)
Time frame: Up to approximately 12 weeks
Percentage of Participants Who Experience a Perioperative Complication
Time frame: Up to approximately 20 weeks
Mean Length of Hospital Stay
Time frame: Up to approximately 20 weeks
Percentage of Participants Who Require Hospital Readmission after Discharge
Time frame: Up to approximately 20 weeks
Mean Length of Surgery
Time frame: Up to approximately 20 weeks
Percentage of Participants Who Require a Blood Transfusion
Time frame: Up to approximately 20 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Plain Language SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Metastatic Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
39 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab (neoadjuvant), Cisplatin and Gemcitabine in people with Lung Neoplasm Malignant, run by Merck Sharp & Dohme LLC at 39 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Ukraine, Turkey (Türkiye), Greece, Italy and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (pCR) (time frame: Up to approximately 20 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.