| Title |
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 |
| Protocole ID |
MK-2870-009 |
| ClinicalTrials.gov ID |
NCT06305754 |
| Cancer Type(s) |
Non Small Cells - Lung |
| Phase |
Phase III |
| Stage |
|
| Study Type |
Clinical |
| Drug |
Sacituzumab tirumotecan versus pemetrexed et carboplatine |
| Institution |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
 SITE GLEN
1001 boul. Décarie , Montréal, QC, H4A 3J1
|
| City |
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| Principal Investigator |
Dr. Benjamin Shieh
|
| Coordinator |
|
| Status |
Recruiting |
| Activation Date |
09-09-2024 |
| Eligibility 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.
|
| Exclusion Criteria |
- 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 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.
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Groupe d'étude en oncologie du Québec