The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    2023-508012-35
Previous Study | Return to List | Next Study

A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06312137
Recruitment Status : Recruiting
First Posted : March 15, 2024
Last Update Posted : May 30, 2024
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme LLC

Brief Summary:
This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Biological: Sacituzumab tirumotecan Biological: Pembrolizumab Drug: Cisplatin Drug: Pemetrexed Drug: Gemcitabine Drug: Carboplatin Drug: Paclitaxel Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 780 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a multi site study
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3 Randomized Open-Label Study of Adjuvant Pembrolizumab With or Without MK-2870 in Participants With Resectable Stage II to IIIB (N2) NSCLC Not Achieving pCR After Receiving Neoadjuvant Pembrolizumab With Platinum-based Doublet Chemotherapy Followed by Surgery
Actual Study Start Date : April 3, 2024
Estimated Primary Completion Date : February 21, 2034
Estimated Study Completion Date : October 23, 2034

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: Pembrolizumab + Sacituzumab tirumotecan
Participants will receive pembrolizumab 200 mg intravenous (IV) infusion every 3 weeks (Q3W) for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by sacituzumab tirumotecan 4 mg/kg IV infusion every 2 weeks (Q2W) for up to 20 doses (~40 weeks) with pembrolizumab monotherapy 200 mg IV infusion every 6 weeks (Q6W) for up to 7 cycles (~42 weeks).
Biological: Sacituzumab tirumotecan
Sacituzumab tirumotecan to be administered as 4mg/kg IV infusion q2w for up to 40 weeks
Other Name: MK-2870

Biological: Pembrolizumab
Pembrolizumab to be administered 400mg by IV infusion q6w for up to 42 weeks
Other Name: MK-3475

Active Comparator: Pembrolizumab
Participants will receive pembrolizumab 200 mg intravenous (IV) infusion Q3W for up to 12 weeks + double-platinum chemotherapy per neoplasm histology classification at the investigator's discretion as neoadjuvant therapy prior to surgery; followed by pembrolizumab monotherapy 200 mg IV infusion Q6W for up to 7 cycles (~42 weeks).
Biological: Pembrolizumab
Pembrolizumab to be administered 400mg by IV infusion q6w for up to 42 weeks
Other Name: MK-3475

Drug: Cisplatin
Cisplatin is administered as 75 mg/m2 IV infusion q3w for up to 12 weeks as background treatment in neoadjuvant phase

Drug: Pemetrexed
Pemetrexed will be administered in the neoadjuvant phase as 500 mg/m2 IV infusion q3w for up to 12 weeks as background treatment in participants with nonsquamous NSCLC.

Drug: Gemcitabine
Gemcitabine will be administered in the neoadjuvant phase as 1000 mg/m2 or 1250 mg/m2 IV infusion on day 1 and day 8 q3w for up to 24 weeks as background treatment in participants with squamous NSCLC.

Drug: Carboplatin
Carboplatin will be administered in the neoadjuvant phase as AUC 5 mg/mL/min or AUC 6 mg/mL/min IV infusion q3w for up to 12 weeks as background treatment.

Drug: Paclitaxel
Paclitaxel will be administered in the neoadjuvant phase as 175 mg/m2 or 200 mg/m2 IV infusion q3w for up to 12 weeks as background treatment.




Primary Outcome Measures :
  1. Disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to ~ 93 months ]
    DFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, or death due to any cause, whichever occurs first.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to ~ 118 months ]
    OS is defined as the time from randomization to death due to any cause.

  2. Distant metastasis-free survival (DMFS) as assessed by investigator [ Time Frame: Up to ~ 118 months ]
    DMFS is defined as the time from randomization to the first documented distant metastasis or death due to any cause, whichever occurs first. Distant metastasis refers to cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes.

  3. Disease-Free Survival (DFS) as assessed by investigator [ Time Frame: Up to ~ 118 months ]
    DFS is defined as the time from randomization to any recurrence (local, locoregional, regional or distant), occurrence of new primary NSCLC, or death due to any cause, whichever occurs first.

  4. Lung Cancer Specific Survival (LCSS) [ Time Frame: Up to ~ 118 months ]
    LCSS is defined as the time from randomization to the date of death due to lung cancer.

  5. Number of Participants Who Experience at least One Adverse Event (AE) [ Time Frame: Up to ~ 118 months ]
    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.

  6. Number of Participants Who Discontinue Study Intervention Due to AEs [ Time Frame: Up to ~ 118 months ]
    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. The percentage of participants who discontinue study treatment due to an AE will be presented.

  7. Change from Baseline in Global Health Status/Quality of Life (QoL) score (Quality of Life Questionnaire (QLQ)-C30 Items 29 and 30) [ Time Frame: Baseline and up to ~118 months ]
    The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) is a psychometrically and clinically validated instrument appropriate for assessing the health-related quality of life (HRQoL) of cancer patients in oncology studies. Each scale or item is scored between 0 and 100, for the global health status or QoL a higher value indicates a better level of function.

  8. Change from Baseline in Physical Functioning Score (QLQ-C30 Items 1 to 5) [ Time Frame: Baseline and up to ~118 months ]
    The EORTC-QLQ is a psychometrically and clinically validated instrument appropriate for assessing the HRQoL of cancer patients in oncology studies. Each scale or item is scored between 0 and 100, for all physical functional scales, a higher value indicates a better level of function.

  9. Change from Baseline in Role Functioning Score (QLQ-C30 Items 6 and 7) [ Time Frame: Baseline and up to ~118 months ]
    The EORTC-QLQ is a psychometrically and clinically validated instrument appropriate for assessing the HRQoL of cancer patients in oncology studies. Each scale or item is scored between 0 and 100, for all role functional scales, a higher value indicates a better level of function.

  10. Change from Baseline in Dyspnea scores (QLQ-C30 Item 8) [ Time Frame: Baseline and up to ~118 months ]
    The EORTC-QLQ is a psychometrically and clinically validated instrument appropriate for assessing the HRQoL of cancer patients in oncology studies. Each scale or item is scored between 0 and 100, for symptom scales such as dyspnea, a higher value indicates increased severity of symptoms.

  11. Change from Baseline in Coughing scores (QLQ-LC24 Items 31 and 52) [ Time Frame: Baseline and up to ~118 months ]
    The lung cancer module of the EORTC, QLQ-LC24 is a revised and updated version of the Lung Cancer Module QLQ-LC13 and is a supplementary lung cancer specific module to be used along with EORTC QLQ C30. The QLQ-LC24 incorporates 4 multi-item scales to assess coughing, shortness of breath, hair problems, and fear of progression, for symptom scales as for cough, a higher value indicates increased severity of symptoms.

  12. Change from Baseline in Chest pain scores (QLQ-LC24 Item 40) [ Time Frame: Baseline and up to ~118 months ]
    The lung cancer module of the EORTC, QLQ-LC24 is a revised and updated version of the Lung Cancer Module QLQ-LC13 and is a supplementary lung cancer specific module to be used along with EORTC QLQ C30. The QLQ-LC24 incorporates 4 multi-item scales to assess coughing, shortness of breath, hair problems, and fear of progression, for symptom scales as for chest pain, a higher value indicates increased severity of symptoms.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

The key inclusion and exclusion criteria include but are not limited to the following:

Inclusion Criteria:

  • Has histological or cytological confirmation of squamous or nonsquamous non-small cell lung cancer (NSCLC), resectable clinical Stage II, IIIA or IIIB (with nodal involvement [N2]) per AJCC eighth edition guidelines.
  • Has confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy.
  • Is able to undergo surgery based on opinion of investigator after consultation with surgeon.
  • Is able to receive neoadjuvant pembrolizumab and platinum-based doublet chemotherapy.
  • Applies to screening for the adjuvant period only, before randomization: Has not achieved pathological complete response (pCR) at surgery by local review of pathology.
  • Applies to screening for the adjuvant period only, before randomization: Tumor tissue sample from surgical resection has been provided for determination of programmed cell death ligand 1 (PD-L1) and trophoblast cell surface antigen 2 (TROP2) status by central vendor before randomization into the adjuvant period.
  • Applies to screening for the adjuvant period only, before randomization: Confirmed to be disease-free based on re-baseline radiological assessment as documented by contrast enhanced chest/abdomen/pelvis computed tomography (CT) (or magnetic resonance imaging (MRI)) within 28 days before randomization.
  • Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible.
  • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART).
  • Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load at screening.
  • Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at least 4 weeks before the start of study intervention.

Exclusion Criteria:

  • Has one of the following tumor locations/types:

    • NSCLC involving the superior sulcus
    • Large cell neuro-endocrine cancer (LCNEC)
    • Sarcomatoid tumor
    • Diagnosis of SCLC or, for mixed tumors, presence of small cell elements
    • Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements
  • Has Grade ≥2 peripheral neuropathy.
  • Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.
  • Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease.
  • Has uncontrolled, significant cardiovascular disease or cerebrovascular disease, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QT corrected for heart rate by Fridericia's cube root formula (QTcF) interval to >480 ms, and/or other serious cardiovascular and cerebrovascular diseases within the 6 months preceding study intervention.
  • Has received prior neoadjuvant therapy for their current NSCLC diagnosis.
  • Has received prior systemic anticancer therapy including investigational agents within 4 weeks before the first dose of study intervention.
  • Has received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.
  • Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
  • Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
  • Has a 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 the first dose of study medication.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 5 years.
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years.
  • Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Has an active infection requiring systemic therapy.
  • Is an HIV-infected participant with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
  • Has a concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection.
  • Has a severe hypersensitivity (Grade ≥3) to sacituzumab tirumotecan, any of its excipients and/or to another biologic therapy.
  • Has a history of allogeneic tissue/solid organ transplant.
  • Has not adequately recovered from major surgery or have ongoing surgical complications.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06312137


Contacts
Layout table for location contacts
Contact: Toll Free Number 1-888-577-8839 Trialsites@merck.com

Locations
Layout table for location information
United States, Florida
Mid Florida Hematology and Oncology Center ( Site 0018) Recruiting
Orange City, Florida, United States, 32763
Contact: Study Coordinator    407-353-1915      
United States, Minnesota
Allina Health Cancer Institute - Abbott Northwestern Hospital ( Site 0027) Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Study Coordinator    651-241-7025      
United States, Nevada
Renown Regional Medical Center-Renown Health Medical Oncology ( Site 0037) Recruiting
Reno, Nevada, United States, 89502
Contact: Study Coordinator    775-985-4000      
Hong Kong
Queen Mary Hospital ( Site 3400) Recruiting
Hksar, Hong Kong
Contact: Study Coordinator    +852 39103299      
Israel
Rambam Health Care Campus-Oncology Division ( Site 2203) Recruiting
Haifa, Israel, 3109601
Contact: Study Coordinator    04-777-6700      
Shaare Zedek Medical Center ( Site 2206) Recruiting
Jerusalem, Israel, 9103102
Contact: Study Coordinator    +972587040620      
Rabin Medical Center ( Site 2204) Recruiting
Petah Tikva, Israel, 4941 492
Contact: Study Coordinator    + 9729378101      
Sheba Medical Center ( Site 2200) Recruiting
Ramat Gan, Israel, 5265601
Contact: Study Coordinator    +972-54-9269938      
Korea, Republic of
Chungbuk National University Hospital-Internal medicine ( Site 1000) Recruiting
Cheongju-si, Chungbuk, Korea, Republic of, 28644
Contact: Study Coordinator    82432696015      
National Cancer Center-Lung Cancer Center ( Site 1002) Recruiting
Goyang-si, Kyonggi-do, Korea, Republic of, 10408
Contact: Study Coordinator    82319201694      
Keimyung University Dongsan Hospital CRC room 1 ( Site 1006) Recruiting
Daegu, Taegu-Kwangyokshi, Korea, Republic of, 42601
Contact: Study Coordinator    82532586671      
Samsung Medical Center-Division of Hematology/Oncology ( Site 1004) Recruiting
Seoul, Korea, Republic of, 06351
Contact: Study Coordinator    82-2-3410-3453      
Switzerland
Kantonsspital Graubünden-Medizin ( Site 3006) Recruiting
Chur, Grisons, Switzerland, 7000
Contact: Study Coordinator    0041 81 256 66 46      
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 1103) Recruiting
Kaohsiung, Taiwan, 807
Contact: Study Coordinator    +888-7-3121101-5651      
Taichung Veterans General Hospital-Chest ( Site 1101) Recruiting
Taichung, Taiwan, 40705
Contact: Study Coordinator    8864235925253218      
National Cheng Kung University Hospital-Clinical Trial Center ( Site 1102) Recruiting
Tainan, Taiwan, 704
Contact: Study Coordinator    886-912777918      
Sponsors and Collaborators
Merck Sharp & Dohme LLC
Investigators
Layout table for investigator information
Study Director: Medical Director Merck Sharp & Dohme LLC
Additional Information:
Layout table for additonal information
Responsible Party: Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier: NCT06312137    
Other Study ID Numbers: 2870-019
2023-508012-35 ( Registry Identifier: EU CT )
MK-2870-019 ( Other Identifier: Merck Id )
First Posted: March 15, 2024    Key Record Dates
Last Update Posted: May 30, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merck Sharp & Dohme LLC:
Carcinoma, Lung cancer, non small cell lung cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Carboplatin
Gemcitabine
Pembrolizumab
Pemetrexed
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antineoplastic Agents, Immunological
Immune Checkpoint Inhibitors
Enzyme Inhibitors
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors