Resumen

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).

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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

Criterios de exclusión

Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
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 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 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

Intervenciones

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/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.

drug

Rescue medication

Participants are allowed to take rescue medication to prevent hypersensitivity and/or infusion reactions as a premedication to study treatment. At the discretion of the investigator, participants are provided with a prescription for rescue medications. Recommended rescue medications are antihistamine, H2 receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent. A steroid mouthwash (dexamethasone or equivalent) may be given as prophylaxis for stomatitis/oral mucositis.

Ubicaciones

Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0213)

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Study Coordinator · +541149590200

RECRUITING

Hospital Británico de Buenos Aires-Oncology ( Site 0207)

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Study Coordinator · +541143096400

RECRUITING

Sanatorio Británico-Clinical Oncology Department ( Site 0206)

Rosario, Santa Fe Province, Argentina

Study Coordinator · 5493416575134

RECRUITING

Sanatorio Parque ( Site 0205)

Rosario, Santa Fe Province, Argentina

Study Coordinator · 5493416955611

RECRUITING

Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 0217)

San Miguel de Tucumán, Tucumán Province, Argentina

Study Coordinator · 543814752113

RECRUITING

Hospital Aleman-Oncology ( Site 0202)

Buenos Aires, Argentina

Study Coordinator · +541148277000

RECRUITING

Hospital Privado Universitario de Córdoba-Hematology and Oncology ( Site 0204)

Córdoba, Argentina

Study Coordinator · +543514688200

RECRUITING

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

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Sacituzumab tirumotecan

Pembrolizumab

Cisplatin

Pemetrexed

Gemcitabine

Carboplatin

Paclitaxel

Rescue medication

Ubicaciones

Hospital Italiano de Buenos Aires-Clinical Oncology ( Site 0213)

Hospital Británico de Buenos Aires-Oncology ( Site 0207)

Sanatorio Británico-Clinical Oncology Department ( Site 0206)

Sanatorio Parque ( Site 0205)

Clínica Mayo de Urgencias Médicas Cruz Blanca S.R.L ( Site 0217)

Hospital Aleman-Oncology ( Site 0202)

Hospital Privado Universitario de Córdoba-Hematology and Oncology ( Site 0204)

Patrocinadores

Contactos

Toll Free Number