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

NCT04685135 · KRYSTAL-12 Phase 3Active, not recruiting

Lead sponsor
Mirati Therapeutics Inc. (Industry)
Enrollment
453 (actual)
Start date
23 Feb 2021
Primary completion
30 Dec 2023 (actual)
Study completion
30 Oct 2026
Last update posted
11 Aug 2026

Design

Study type
Interventional
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel
Masking
None
Arms
2

Interventions

  • MRTX849 Drug
  • Docetaxel Drug

Conditions and primary outcome

  • Metastatic Non Small Cell Lung Cancer
  • Advanced Non Small Cell Lung Cancer

Primary outcome

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))

Posted results on ClinicalTrials.gov

Source: ClinicalTrials.gov results for NCT04685135 (opens in a new tab)· Licence: public-domain

First posted · Last update posted · Imported from ClinicalTrials.gov download 2026-10-25

Primary outcomes with a statistical analysis

  1. Progression-Free Survival (PFS) as Per Blinded Independent Central Review

    Time frame
    From randomization to the date of progression or death due to any cause, whichever occurs first (up to approximately 143 weeks)
    Measure
    Median
    Unit
    months

    • Adagrasib vs DocetaxelSuperiority

      Estimate
      0.58Hazard Ratio (HR)
      95% CI, two-sided
      0.45 to 0.76
      p-value
      <0.0001
      Method
      Log Rank

Serious adverse events

Time frame: All cause mortality and non serious adverse events were reported from first first dose of treatment (Day 1) till 28 days after last dose (Up to approximately 110 weeks). Serious adverse events were collected from date of signing of informed consent form till 28 days after last dose (Up to approximately 111 weeks).

Participants with serious adverse events per group for KRYSTAL-12, as posted
GroupAffectedAt risk
Adagrasib149298
Docetaxel50140
Crossover Adagrasib2044

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Results from company and journal sources

No editor-confirmed results are on record for this study.

Publications

2 on PubMed

  1. Plain language summary of the KRYSTAL-12 study results: adagrasib for non-small cell lung cancer with KRAS(G12C) mutations.

    Future oncology (London, England) · 2026 Aug

    PubMed 42745627 (opens in a new tab)DOI 10.1080/14796694.2026.2719409 (opens in a new tab)

  2. Adagrasib versus docetaxel in KRAS(G12C)-mutated non-small-cell lung cancer (KRYSTAL-12): a randomised, open-label, phase 3 trial.

    Lancet (London, England) · 2025 Aug 9

    PubMed 40783289 (opens in a new tab)DOI 10.1016/S0140-6736(25)00866-9 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

CT-VCA trial quality

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Data integrity

Compare what the registry, company releases, FDA documents and publications say about this study.

Drugs on HealthTrade

Source

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Listing a study does not mean NLM has evaluated it.

Nothing on this page is medical or investment advice.