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Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)
Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)

NCT05853575

Active Not RecruitingPhase 2

Sponsor: Mirati Therapeutics Inc.

Conditions: Advanced Cancer, Metastatic Cancer, Malignant Neoplasm of Lung

Interventions: Adagrasib

Countries: United States, Brazil, Croatia, France, Greece, Israel, Italy, Japan

This study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID versus 400 mg BID) in patients with NSCLC with KRAS G12C mutation.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Key Inclusion Criteria:

* Are at least 18 years old (or old enough to legally make their own treatment decisions, according to local laws).
* Have advanced NSCLC or metastatic NSCLC (NSCLC that started in the lungs and then spread to other parts of the body) with the KRAS G12C mutation.
* Have had previous treatment with 1) chemotherapy that included a drug called cisplatin or a drug called carboplatin and 2) a type of drug called an immune checkpoint inhibitor.
* Have recovered from their prior treatment and blood tests are within a safe range.

Key Exclusion Criteria:

* Have had previous treatment with a drug that targets KRAS G12C.
* Have cancer that can potentially be removed with surgery.
* Patients with brain lesions are not eligible if 1) any untreated brain lesions are \> 2.0 cm in size 2) any brainstem lesions are present 3) ongoing steroid dosing \>10 mg daily prednisone (or equivalent) and 4) poorly controlled (\> 1/week) generalized or complex partial seizures or neurologic progression/instability due to brain lesions.
* Have certain medical conditions or need to take certain medications that, in the opinion of a trial doctor, could make it unsafe for them to participate or difficult to complete the trial assessments, or are pregnant.
Locations (98)
  • Santa Rosa, California, United States
  • Kansas City, Missouri, United States
  • Durham, North Carolina, United States
  • Dallas, Texas, United States
  • Salvador, Estado de Bahia, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • Itajaí, Santa Catarina, Brazil
  • Belo Horizonte, São Paulo, Brazil
  • São Paulo, Brazil
  • São Paulo, Brazil
  • Zagreb, City of Zagreb, Croatia
  • Rijeka, Primorje-Gorski Kotar County, Croatia
  • Grenoble, Auvergne-Rhône-Alpes, France
  • Pessac, Gironde, France
  • Saint-Herblain, Loire-Atlantique, France
  • Angers, Maine-et-Loire, France
  • Lorient, Morbihan, France
  • Nantes, Pays de la Loire Region, France
  • Poitiers, Poitou-Charentes, France
  • Nice, Provence-Alpes-Côte d'Azur Region, France
  • Marseille, Rhône, France
  • Villefranche-sur-Saône, Rhône, France
  • Paris, France
  • Quimper, France
  • Saint-Mandé, France
  • Pátrai, Achaïa, Greece
  • Athens, Attica, Greece
  • Thessaloniki, North Aegean, Greece
  • Haidari - Athens, Pella, Greece
  • Thessaloniki, Greece
  • + 68 more on CT.gov