RecruitingNCT06312137ClinicalTrials.gov record

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)

Non Small Cell Lung Cancer

Ask WCR about this study Official registry record ↗

THE QUICK READ

What this study involves

The registry says this study is recruiting. Individual locations may have different availability.

Study type: Interventional
Phase: Phase 3
Age range: 18 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 780 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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).

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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

Understand screening

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment: Not randomized
Masking: Single masked

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 12 doses (\~24 weeks) with pembrolizumab monotherapy 200 mg IV infusion every 6 weeks (Q6W) for up to 7 cycles (\~42 weeks).

Biological: Sacituzumab tirumotecan · Biological: Pembrolizumab · Drug: Rescue medication

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 · Drug: Cisplatin · Drug: Pemetrexed · Drug: Gemcitabine · Drug: Carboplatin · Drug: Paclitaxel

Sacituzumab tirumotecan BIOLOGICAL

Sacituzumab tirumotecan to be administered as 4mg/kg IV infusion q2w for up to 24 weeks

Pembrolizumab BIOLOGICAL

Pembrolizumab to be administered 400mg by IV infusion q6w for up to 42 weeks

Cisplatin DRUG

Cisplatin is administered as 75 mg/m\^2 IV infusion q3w for up to 12 weeks as background treatment in neoadjuvant phase

Pemetrexed DRUG

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.

Gemcitabine DRUG

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.

Carboplatin DRUG

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.

Paclitaxel DRUG

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.

Rescue medication DRUG

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.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

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.