Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

Condition(s) studied

Investigational drug(s) / intervention(s)

MRTX849: 21 day cycles

Docetaxel: 21 day cycles

Study summary

This Phase 3 study will evaluate the efficacy of the investigational agent MRTX849 (adagrasib) versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRAS G12C mutation.

Eligibility

Primary outcome measure(s)

• Progression-Free Survival (PFS) as Per Blinded Independent Central Review — From randomization to the date of progression or death due to any cause, whichever occurs first (up to approximately 143 weeks)
  Progression-free survival (PFS) is defined as the time from randomization to the date of progression or death due to any cause, whichever occurs first. 95% CI was obtained using Brookmeyer and Crowley method. Participants who are not observed to have progressed or died are censored at the date of last evaluable tumor assessment. Disease progression assessed as per RECISIST 1.1 was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Trial sites (380)

+ 340 more sites — see the full list on the official registry below.

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