A Study Evaluating Sotorasib Platinum Doublet Combination Versus

Resolution Criteria Trial: NCT05920356 Selected endpoint key: 735e3a1fc2f54e5293f36b0e2275334cb2783e2120af5a86a0ada5e06a7f7a43 Selected endpoint: Progression-free Survival (PFS) Endpoint type: PFS Protocol outcome group: primary Endpoint description: PFS is defined as the time from randomization until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first. Progression will be based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, per Blinded Independent Central Review (BICR). Endpoint timeframe: Approximately 2.5 years ClinicalTrials.gov population: Randomized participants with Stage IV or advanced Stage IIIB/C nonsquamous non-small cell lung cancer that is KRAS p.G12C-positive and PD-L1-negative. Market population: Randomized participants with Stage IV or advanced Stage IIIB/C nonsquamous non-small cell lung cancer that is KRAS p.G12C-positive and PD-L1-negative. Analysis set: Prespecified primary progression-free-survival analysis set; further analysis-set details are not stated in the ClinicalTrials.gov outcome description. Comparison: Sotorasib plus platinum doublet chemotherapy versus pembrolizumab plus platinum doublet chemotherapy. Success direction: superiority Success rule: Progression-free survival must be statistically superior with sotorasib plus platinum doublet chemotherapy versus pembrolizumab plus platinum doublet chemotherapy in the prespecified primary analysis set. PFS is time from randomization to the first documented radiologic disease progression or death from any cause, whichever occurs first, with progression assessed under RECIST v1.1 by blinded independent central review, over approximately 2.5 years. Because no numerical threshold or alpha rule is disclosed in the registry outcome, the prespecified statistical success criterion must be met. ClinicalTrials.gov source: https://clinicaltrials.gov/study/NCT05920356?tab=researcher#outcome-measures:~:text=Progression-free%20Survival%20(PFS) YES 1. The exact selected endpoint (Progression-free Survival (PFS)) 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 (Progression-free Survival (PFS)) misses its approved success rule. 2. No qualifying disclosure of the selected endpoint is available by 2028-02-29 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: 2028-02-29T23:59:59Z Deadline evidence: AI bounded approximation (confidence 70/100): official source supports 2028-02-01 through 2028-02-29; market deadline 2028-02-29 is the conservative end of that window. Amgen officially stated that FDA issued a new postmarketing requirement for an additional confirmatory study supporting full approval of LUMAKRAS, to be completed no later than February 2028. The same official pipeline update identifies the enrolling Phase 3 first-line study of LUMAKRAS plus chemotherapy versus pembrolizumab plus chemotherapy. Because Amgen supplied only a month and year rather than an exact day, the conservative normalized deadline is the last calendar day of February 2028. The source does not explicitly identify the additional confirmatory study by the CodeBreaK 202 name, which reduces confidence. Deadline evidence source: https://www-ext.amgen.com/newsroom/press-releases/2024/02/amgen-reports-fourth-quarter-and-full-year-2023-financial-results 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.