Sacituzumab tirumotecan for lung cancer (TroFuse-004)

Resolution Criteria Trial: NCT06074588 Selected endpoint key: 61de4c2ddb62dc8b2207bf945ad5c04a5f36bc612cf68924383504bc85d25f21 Selected endpoint: Overall Survival (OS) of Participants with NSCLC with Epidermal Growth Factor Receptor (EGFR) Mutations Endpoint type: OS Protocol outcome group: primary Endpoint description: OS is defined as the time from randomization to death due to any cause. Endpoint timeframe: Up to approximately 41 months ClinicalTrials.gov population: Participants with previously treated advanced or metastatic nonsquamous NSCLC with EGFR mutations Market population: Participants with previously treated advanced or metastatic nonsquamous NSCLC with EGFR mutations Analysis set: EGFR-mutated NSCLC population; the public outcome record does not further specify the analysis set Comparison: Sacituzumab tirumotecan versus chemotherapy with docetaxel or pemetrexed Success direction: higher Success rule: Overall survival, defined as time from randomization to death due to any cause, must be longer with sacituzumab tirumotecan than with docetaxel or pemetrexed in participants with EGFR-mutated NSCLC at the specified time frame of up to approximately 41 months, and the prespecified statistical success criterion for this OS comparison must be met. ClinicalTrials.gov source: https://clinicaltrials.gov/study/NCT06074588?tab=researcher#outcome-measures:~:text=Overall%20Survival%20(OS)%20of%20Participants%20with%20NSCLC%20with%20Epidermal%20Growth%20Factor%20Receptor%20(EGFR)%20Mutations YES 1. The exact selected endpoint (Overall Survival (OS) of Participants with NSCLC with Epidermal Growth Factor Receptor (EGFR) Mutations) satisfies the approved success rule in the specified population, analysis set, comparison, and timepoint. 2. The result is supported by a qualifying source in the approved evidence hierarchy. NO 1. The exact selected endpoint (Overall Survival (OS) of Participants with NSCLC with Epidermal Growth Factor Receptor (EGFR) Mutations) misses its approved success rule. 2. No qualifying disclosure of the selected endpoint is available by 2027-05-31 at 23:59:59 UTC. NO DECISION / ADMIN REVIEW 1. Available evidence is contradictory, incomplete, pooled, interim, subgroup-only, or does not match the approved population, analysis set, comparison, and timepoint. Resolution deadline: 2027-05-31T23:59:59Z Deadline evidence: AI bounded approximation (confidence 78/100): official source supports 2027-05-01 through 2027-05-31; market deadline 2027-05-31 is the conservative end of that window. Merck's official TroFuse clinical-trial explainer identifies TroFuse-004/NCT06074588, lists PFS and OS as efficacy endpoints, and gives May 2027 as the estimated primary-completion window. Because the official source provides only a month rather than an exact disclosure day, the conservative deadline is normalized to the last calendar day of May 2027; it is not treated as an exact source date. Deadline evidence source: https://www.merck.com/wp-content/uploads/sites/124/2026/05/TroFuse_Clinical_Trial_Explainer.pdf Evidence precedence 1. ClinicalTrials.gov posted results 2. Sponsor regulatory filing or official release 3. Peer-reviewed publication or official conference abstract Only the selected endpoint in the specified population, analysis set, comparison, and timeframe can resolve YES. Overall positive messaging, another endpoint, interim results, pooled analyses, or an unmatched subgroup cannot resolve YES.