Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 3
Merck Sharp & Dohme LLC (Voir sur ClinicalTrials)
avril 2024
octobre 2034
28 décembre 2024
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).
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Tenon | Study Coordinator | Contact (sur clinicalTrials) | |||
| GH PARIS SITE SAINT JOSEPH | Study Coordinator | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren ( Site 1805) - 87042 - Limoges - Haute-Vienne - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne-ONCOLOGY ( Site 1810) - 63003 - Clermont-Ferrand - Puy-de-Dome - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| CHRU de Brest ( Site 1804) - 29609 - Brest - Finistere - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| CHU de Toulouse - Hopital Larrey-service de pneumologie ( Site 1801) - 31400 - Toulouse - Haute-Garonne - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| Clinique Teissier Groupe ( Site 1811) - 59304 - Valenciennes - Nord - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| HIA Sainte Anne ( Site 1800) - 83800 Cedex 9 - Toulon - Var - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| Hospices Civils de Lyon - Hopital Louis Pradel ( Site 1809) - 69677 - Bron - Rhone - France | Study Coordinator | Contact (sur clinicalTrials) | |||
Critères
Tous
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.
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.