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
Merck Sharp & Dohme LLC
Summary
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 is that sacituzumab tirumotecan is better than platinum-based doublet chemotherapy (pemetrexed and carboplatin) in regard to overall survival (OS).
Description
Participants will be randomized 1:1 into two arms: * Sacituzumab tirumotecan * Pemetrexed plus Carboplatin Participants will receive treatment until any of the criteria for discontinuation of study intervention are met.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 immunod…
Interventions
- BiologicalSacituzumab tirumotecan
4 mg/kg via IV infusion
- DrugPemetrexed
500 mg/m\^2 via IV infusion
- DrugCarboplatin
AUC 5 mg/mL\*min via IV infusion
- DrugH1 Receptor Antagonist
Administered as rescue medication per approved product label
- DrugH2 Receptor Antagonist
Administered as rescue medication per approved product label
- DrugAcetaminophen (or equivalent)
Administered as rescue medication per approved product label
- DrugDexamethasone (or equivalent)
Locations (156)
- Kaiser Permanente - Oakland ( Site 0054)Oakland, California
- Kaiser Permanente - Roseville ( Site 0055)Roseville, California
- Kaiser Permanente - San Francisco ( Site 0056)San Francisco, California
- Kaiser Permanente - Santa Clara ( Site 0057)Santa Clara, California
- Kaiser Permanente-Kaiser Permanente ( Site 0036)Vallejo, California
- Kaiser Permanente - Walnut Creek ( Site 0058)Walnut Creek, California