Adagrasib Trial Reaches Phase 3 Primary Completion in NSCLC

A Phase 3 study evaluating adagrasib reached primary completion on 19 May 2026, according to ClinicalTrials.gov. The trial enrolled 338 participants with previously treated, KRAS G12C-positive advanced or metastatic non-small cell lung cancer and compared divarasib with locally approved KRAS G12C inhibitors, including adagrasib and sotorasib.

Background

The study addressed advanced or metastatic non-small cell lung cancer in participants whose tumors were KRAS G12C-positive and who had received previous treatment. Its stated purpose was to assess the safety and efficacy of divarasib against locally approved KRAS G12C inhibitors, either sotorasib or adagrasib. The supplied record does not provide additional information about the drugs’ mechanisms, prior approvals, treatment dosing, or the prevalence of KRAS G12C-positive lung cancer.

Trial design

This Phase 3 study, identified as NCT06497556, enrolled 338 participants. The listed conditions were non-small cell lung cancer and KRAS G12C lung cancer. The interventions were divarasib, sotorasib, and adagrasib. The study status was active, not recruiting at the time represented in the supplied record.

The trial evaluated divarasib versus locally approved KRAS G12C inhibitors in participants with previously treated disease. The supplied data do not list primary-outcome measures, key measurements, key analyses, or an adverse-event summary.

What this means

Primary completion marks a major registry milestone for this comparative Phase 3 evaluation, but the supplied record does not report efficacy or safety results. It therefore does not establish whether divarasib performed better than sotorasib or adagrasib, nor does it provide a basis for comparing adverse-event rates. The available information confirms the study population, treatment groups, enrollment, and completion milestone only.

Because no outcome measurements or statistical analyses were supplied, there are no reported response rates, survival values, confidence intervals, or p-values to interpret. The study remained listed as active, not recruiting, despite reaching its primary completion date.

Source

Source: ClinicalTrials.gov, registry record for the Phase 3 study “A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer,” dated 19 May 2026. Available at clinicaltrials.gov/study/NCT06497556.