Recruiting NCT06312137

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)

Phase III Interventional Non Small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Sacituzumab tirumotecan, Pembrolizumab, Cisplatin, Pemetrexed.
Who it may be relevant to: Registry conditions: Non Small Cell Lung Cancer. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Australia, Austria, Belgium +26
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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).

Interventions

Biological Sacituzumab tirumotecan
Sacituzumab tirumotecan to be administered as 4mg/kg IV infusion q2w for up to 24 weeks
Biological Pembrolizumab
Pembrolizumab to be administered 400mg by IV infusion q6w for up to 42 weeks
Drug Cisplatin
Cisplatin is administered as 75 mg/m\^2 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/m\^2 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/m\^2 or 1250 mg/m\^2 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/m\^2 or 200 mg/m\^2 IV infusion q3w for up to 12 weeks as background treatment.
Drug Rescue medication
Participants are permitted to take rescue medications to prevent hypersensitivity and/or infusion reactions as a premedication to study treatment. Rescue medications include antihistamine, H2 receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent, and granulocyte colony-stimulating factor. A steroid mouthwash (dexamethasone or equivalent) may be given as prophylaxis for stomatitis/oral mucositis.

Primary outcome measures

Disease-free survival (DFS) as assessed by Blinded Independent Central Review (BICR) [Time frame: Up to ~ 93 months]

Secondary outcome measures (12)

Overall Survival (OS) [Time frame: Up to ~ 118 months]
Distant metastasis-free survival (DMFS) as assessed by investigator [Time frame: Up to ~ 118 months]
Disease-Free Survival (DFS) as assessed by investigator [Time frame: Up to ~ 118 months]
Lung Cancer Specific Survival (LCSS) [Time frame: Up to ~ 118 months]
Number of Participants Who Experience an Adverse Event (AE) [Time frame: Up to ~ 118 months]
Number of Participants Who Discontinue Study Intervention Due to AEs [Time frame: Up to ~ 118 months]
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]
Change from Baseline in Physical Functioning Score (QLQ-C30 Items 1 to 5) [Time frame: Baseline and up to ~118 months]
Change from Baseline in Role Functioning Score (QLQ-C30 Items 6 and 7) [Time frame: Baseline and up to ~118 months]
Change from Baseline in Dyspnea scores (QLQ-C30 Item 8) [Time frame: Baseline and up to ~118 months]
Change from Baseline in Coughing scores (QLQ-LC24 Items 31 and 52) [Time frame: Baseline and up to ~118 months]
Change from Baseline in Chest pain scores (QLQ-LC24 Item 40) [Time frame: Baseline and up to ~118 months]

Eligibility 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 either epidermal growth factor receptor (EGFR)-directed or anaplastic lymphoma kinase (ALK)-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
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
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) interstitial lung disease (ILD)/pneumonitis, has current ILD/pneumonitis, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at screening
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 history of allogeneic tissue/solid organ transplant
Has not adequately recovered from major surgery or have ongoing surgical complications
Severe hypersensitivity (≥Grade 3) to study intervention, any of its excipients, and/or to another biologic therapy

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Non-randomized
Model: Parallel assignment
Masking: Single blind
Primary purpose: Treatment