Informations générales (source: ClinicalTrials.gov)
A Randomized, Open-label, Phase 3 Study of MK-2870 vs. Platinum Doublets in Participants With EGFR-mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) Who Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors
Interventional
Phase 3
Merck Sharp & Dohme LLC (Voir sur ClinicalTrials)
juin 2024
juin 2030
29 juillet 2025
The purpose of this study is to evaluate sacituzumab tirumotecan versus pemetrexed in
combination with carboplatin for the treatment of epidermal growth factor receptor
(EGFR)-mutated advanced non-squamous non-small cell lung cancer (NSCLC). Participants in
this study have NSCLC that has continued to progress on prior treatment with EGFR
tyrosine kinase inhibitors (TKIs).
The primary hypotheses of this study are that sacituzumab tirumotecan is better than
platinum-based doublet chemotherapy (pemetrexed and carboplatin) in regard to
progression-free survival (PFS) and overall survival (OS).
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 Cochin | Study Coordinator | Contact (sur clinicalTrials) | |||
| CLCC INSTITUT GUSTAVE ROUSSY | 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 | |||||
| Clinique Clairval ( Site 1306) - 13009 - Marseille - Bouches-du-Rhone - France | Study Coordinator | Contact (sur clinicalTrials) | |||
| Nouvel Hôpital Civil (NHC) ( Site 1302) - 67091 - Strasbourg - Alsace - France | Study Coordinator | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of advanced-stage nonsquamous
non-small cell lung cancer (NSCLC).
- Participants who have adverse events (AEs) due to previous anticancer therapies must
have recovered to Grade ≤1 or baseline.
- 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.
- Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV
viral load is undetectable.
- Human immunodeficiency virus (HIV)-infected participants must have well controlled
HIV on antiretroviral therapy.
- Life expectancy of at least 3 months.
- Histologically or cytologically confirmed diagnosis of advanced-stage nonsquamous
non-small cell lung cancer (NSCLC).
- Participants who have adverse events (AEs) due to previous anticancer therapies must
have recovered to Grade ≤1 or baseline.
- 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.
- Participants with history of Hepatitis C virus (HCV) infection are eligible if HCV
viral load is undetectable.
- Human immunodeficiency virus (HIV)-infected participants must have well controlled
HIV on antiretroviral therapy.
- Life expectancy of at least 3 months.
- Predominantly squamous cell histology NSCLC.
- History of second malignancy, unless potentially curative treatment has been
completed with no evidence of malignancy for 3 years.
- Grade ≥2 peripheral neuropathy.
- History of documented severe dry eye syndrome, severe Meibomian gland disease and/or
blepharitis, or severe corneal disease that prevents/delays corneal healing.
- Active inflammatory bowel disease requiring immunosuppressive medication or previous
history of inflammatory bowel disease.
- Uncontrolled, or significant cardiovascular disease or cerebrovascular disease.
- Received prior radiotherapy within 2 weeks of start of study intervention, or
radiation-related toxicities, requiring corticosteroids.
- Received a live or live-attenuated vaccine within 30 days before the first dose of
study intervention. Administration of killed vaccines is allowed.
- Received radiation therapy to the lung that is >30 Gray within 6 months of the first
dose of study intervention.
- Known active central nervous system metastases and/or carcinomatous meningitis.
- Active infection requiring systemic therapy.
- History of (noninfectious) pneumonitis/interstitial lung disease that required
steroids or has current pneumonitis/interstitial lung disease.
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric
Castleman's Disease.
- Concurrent active HBV and HCV infection.
- History of allogeneic tissue/solid organ transplant.
- Participants who have not adequately recovered from major surgery or have ongoing
surgical complications.