Sacituzumab tirumotecan / H1 Receptor Antagonist / Carboplatin · Phase 3 Trial
ClinicalTrials.gov · September 11, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a Phase 3 randomized controlled trial registration comparing sacituzumab tirumotecan to pemetrexed-carboplatin in EGFR-mutated advanced nonsquamous NSCLC after TKI progression. No results have been posted to the registry as of this record; the study is actively recruiting with an estimated 550 participants and overall survival as the primary endpoint measured over approximately 51 months.
Phase 3, Interventional, Randomized, Parallel, Single masking, Treatment purpose. Non-small Cell Lung Cancer (NSCLC); age from 18 Years. Intervention: Sacituzumab tirumotecan. Compared with: Pemetrexed Plus Carboplatin — Active Comparator. n = 550. 156 sites across 19 countries.
This is a Phase 3 randomized controlled trial registration comparing sacituzumab tirumotecan to pemetrexed-carboplatin in EGFR-mutated advanced nonsquamous NSCLC after TKI progression. No results have been posted to the registry as of this record; the study is actively recruiting with an estimated 550 participants and overall survival as the primary endpoint measured over approximately 51 months.
No efficacy, safety, or efficacy data are reported in this registry record.
Results from this trial are not yet available. Once posted, efficacy and safety data comparing sacituzumab tirumotecan to standard chemotherapy in this post-TKI population will inform treatment sequencing in EGFR-mutated NSCLC.
This is a Phase 3 registry record with no posted results; the study is actively enrolling and design facts only can be assessed.
As stated by the source record.
Quoted from the source exactly as published.
Results from this trial are not yet available. Once posted, efficacy and safety data comparing sacituzumab tirumotecan to standard chemotherapy in this post-TKI population will inform treatment sequencing in EGFR-mutated NSCLC.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06305754). This is a study registration, not published results. Lead sponsor: Merck Sharp & Dohme LLC. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 550 participants (ESTIMATED). Conditions: Non-small Cell Lung Cancer (NSCLC). Interventions: BIOLOGICAL: Sacituzumab tirumotecan; DRUG: Pemetrexed; DRUG: Carboplatin; DRUG: H1 Receptor Antagonist; DRUG: H2 Receptor Antagonist; DRUG: Acetaminophen (or equivalent); DRUG: Dexamethasone (or equivalent); DRUG: Steroid Mouthwash (dexamethasone or equivalent). Primary outcome measures: Overall Survival (OS) , Up to approximately 51 months. Brief 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).
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.