Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MK-3475-01E | Other Identifier | MSD Protocol Number | |
| KEYMAKER-U01 | Other Identifier | MSD | |
| 2023-509234-19-00 | Registry Identifier | EU CT | |
| U1111-1299-6753 | Registry Identifier | UTN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pembrolizumab (neoadjuvant) | Biological | Before surgery neoadjuvant Pembrolizumab 200 mg by intravenous (IV) infusion on day 1 of each 21-day cycle for 4 cycles |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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.) | Up to approximately 20 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
The main inclusion and exclusion criteria include but are not limited to the following:
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Toll Free Number | Contact | 1-888-577-8839 | Trialsites@msd.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern Cancer Center (SCC) ( Site 8004) | Recruiting | Daphne | Alabama | 36526 | United States |
Not provided
| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
| Plain Language Summary | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Cisplatin | Drug | Cisplatin 75 mg/m^2 by IV infusion on day 1 of each 21-day cycle for 4 cycles |
|
|
| Gemcitabine | 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 | 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 | 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 | Drug | Administered as rescue medication before Sacituzumab tirumotecan infusion per approved product label |
|
| H2 receptor antagonist | Drug | 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 |
|
| Carboplatin | 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) | Biological | After surgery adjuvant Pembrolizumab 200 mg by IV infusion on day 1 of each 21-day cycle for 13 cycles |
|
|
| Paclitaxel | 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) | Drug | Administered orally as rescue medication 2-5 mL 4 times daily |
|
| 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. | 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. | Up to approximately 5 years |
| Overall Survival (OS) | OS is defined as the time from randomization to death due to any cause. | 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. | 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. | Up to approximately 12 weeks |
| Percentage of Participants Who Experience a Perioperative Complication | Perioperative Complications include both intraoperative and postoperative complications. | Up to approximately 20 weeks |
| Mean Length of Hospital Stay | Hospital Stay is the length of inpatient time spent in hospital. | 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. | Up to approximately 20 weeks |
| Mean Length of Surgery | Length of surgery is the time spent in surgery. | 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. | Up to approximately 20 weeks |
| Sansum Clinic (Ridley Tree) ( Site 8012) | Recruiting | Santa Barbara | California | 93105 | United States |
|
| Rocky Mountain Cancer Centers (RMCC) ( Site 8011) | Recruiting | Lone Tree | Colorado | 80124 | United States |
|
| MedStar Franklin Square Medical Center ( Site 0033) | Recruiting | Baltimore | Maryland | 21237 | United States |
|
| Oncology Associates of Oregon, P.C.(Willamette Valley Cancer Institute) (WVCI) ( Site 8006) | Recruiting | Eugene | Oregon | 97401 | United States |
|
| Texas Oncology - Central/South Texas ( Site 8009) | Recruiting | Austin | Texas | 78705 | United States |
|
| Texas Oncology - Northeast Texas ( Site 8005) | Recruiting | Tyler | Texas | 75702 | United States |
|
| Virginia Cancer Specialists (VCS) ( Site 8002) | Recruiting | Fairfax | Virginia | 22031 | United States |
|
| Centro de Estudios Clínicos SAGA ( Site 0162) | Recruiting | Santiago | Region M. de Santiago | 7500653 | Chile |
|
| FALP ( Site 0161) | Recruiting | Santiago | Region M. de Santiago | 7500921 | Chile |
|
| Bradfordhill ( Site 0160) | Recruiting | Santiago | Region M. de Santiago | 8420383 | Chile |
|
| Alexandra General Hospital of Athens Oncology-Hematology Unit ( Site 0203) | Recruiting | Athens | Attica | 115 28 | Greece |
|
| ATTIKON GENERAL UNIVERSITY HOSPITAL-Oncology ( Site 0202) | Recruiting | Athens | Attica | 12462 | Greece |
|
| Metropolitan Hospital-4th Oncology Dept ( Site 0201) | Recruiting | Athens | Attica | 185 47 | Greece |
|
| University General Hospital of Heraklion ( Site 0200) | Recruiting | Heraklion | Irakleio | 71110 | Greece |
|
| Petz Aladar Egyetemi Oktato Korhaz-Pulmonológia (Dr. Szalai Zsuzsanna) ( Site 0062) | Recruiting | Győr | Győr-Moson-Sopron | 9024 | Hungary |
|
| Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház-Onkologiai Kozpont ( Site 0061) | Recruiting | Szolnok | Jász-Nagykun-Szolnok | 5000 | Hungary |
|
| Országos Korányi Pulmonológiai Intézet ( Site 0060) | Recruiting | Budapest | 1121 | Hungary |
|
| Azienda Ospedaliera Universitaria Careggi ( Site 0173) | Recruiting | Florence | Tuscany | 50134 | Italy |
|
| Ospedale San Raffaele. ( Site 0171) | Recruiting | Milan | 20132 | Italy |
|
| Fondazione IRCCS Istituto Nazionale dei Tumori ( Site 0175) | Recruiting | Milan | 20133 | Italy |
|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 0174) | Recruiting | Roma | 00168 | Italy |
|
| Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz ( Site 0153) | Recruiting | Poznan | Greater Poland Voivodeship | 60-569 | Poland |
|
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151) | Recruiting | Warsaw | Masovian Voivodeship | 02-781 | Poland |
|
| Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150) | Recruiting | Gdansk | Pomeranian Voivodeship | 80-952 | Poland |
|
| Hospital Clinic de Barcelona ( Site 0092) | Recruiting | Barcelona | 08008 | Spain |
|
| Baskent University Dr. Turgut Noyan Research and Training Center-ONCOLOGY ( Site 0702) | Recruiting | Adana | 01250 | Turkey (Türkiye) |
|
| Hacettepe Universite Hastaneleri-oncology hospital ( Site 0700) | Recruiting | Ankara | 06230 | Turkey (Türkiye) |
|
| Akdeniz Universitesi Hastanesi-Medical Oncology ( Site 0704) | Recruiting | Antalya | 07059 | Turkey (Türkiye) |
|
| İzmir Suat Seren Chest Disease Training & Research Hospital ( Site 0701) | Recruiting | Izmir | 35110 | Turkey (Türkiye) |
|
| Ondokuz Mayıs Universitesi-Oncology department ( Site 0706) | Recruiting | Samsun | 55139 | Turkey (Türkiye) |
|
| CNE CC of Oncology Hematol ( Site 0130) | Recruiting | Cherkasy | Cherkasy Oblast | 18009 | Ukraine |
|
| Municipal Enterprise "Bukovinian сlinical oncology сenter" ( Site 0139) | Recruiting | Chernivtsi | Chernivetska Oblast | 58013 | Ukraine |
|
| CNCE Precarpathian Clinical Oncologic Center ( Site 0131) | Recruiting | Ivano-Frankivsk | Ivano-Frankivsk Oblast | 76018 | Ukraine |
|
| MNPE LTMU Multidisc. Clin. Hosp. of Emerg. and Intens. Care ( Site 0132) | Recruiting | Lviv | Lviv Oblast | 79059 | Ukraine |
|
| ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0460) | Recruiting | Rivne | Rivne Oblast | 33010 | Ukraine |
|
| Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council" ( Site 0135) | Recruiting | Vinnytsia | Vinnytsia Oblast | 21029 | Ukraine |
|
| Shalimov Institute of Surgery and Transplantation ( Site 0138) | Recruiting | Kyiv | 03126 | Ukraine |
|
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D020360 | Neoadjuvant Therapy |
| D002945 | Cisplatin |
| D000093542 | Gemcitabine |
| D000068437 | Pemetrexed |
| D006633 | Histamine Antagonists |
| D006635 | Histamine H2 Antagonists |
| D000082 | Acetaminophen |
| D003907 | Dexamethasone |
| D016190 | Carboplatin |
| D000277 | Adjuvants, Pharmaceutic |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D018494 | Histamine Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D056831 | Coordination Complexes |
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D020313 | Specialty Uses of Chemicals |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided