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Clinical Trials in Turkey / NCT05853575
Active, not recruiting Phase 2

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

NCT05853575 · tracked via the Priya Life Science Turkey tracker
Phase
Phase 2
Started
2024-02-01
Last updated
2026-08-14

Condition(s) studied

Advanced CancerMetastatic CancerMalignant Neoplasm of Lung

Investigational drug(s) / intervention(s)

Adagrasib →

Adagrasib: KRAS G12C inhibitor

Study summary

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (98)

FacilityCityRegionStatus
Local Institution - 101 Santa Rosa California
Local Institution - 105 Kansas City Missouri
Local Institution - 100 Durham North Carolina
Local Institution - 106 Dallas Texas
Local Institution - 181 Salvador Estado de Bahia
Local Institution - 177 Porto Alegre Rio Grande do Sul
Local Institution - 182 Itajaí Santa Catarina
Local Institution - 178 Belo Horizonte São Paulo
Local Institution - 102 São Paulo Brazil
Local Institution - 175 São Paulo Brazil
Local Institution - 527 Zagreb City of Zagreb
Local Institution - 529 Rijeka Primorje-Gorski Kotar County
Local Institution - 559 Grenoble Auvergne-Rhône-Alpes
Local Institution - 556 Pessac Gironde
Local Institution - 553 Saint-Herblain Loire-Atlantique
Local Institution - 554 Angers Maine-et-Loire
Local Institution - 552 Lorient Morbihan
Local Institution - 555 Nantes Pays de la Loire Region
Local Institution - 557 Poitiers Poitou-Charentes
Local Institution - 561 Nice Provence-Alpes-Côte d'Azur Region
Local Institution - 551 Marseille Rhône
Local Institution - 560 Villefranche-sur-Saône Rhône
Local Institution - 562 Paris France
Local Institution - 558 Quimper France
Local Institution - 550 Saint-Mandé France
Local Institution - 577 Pátrai Achaïa
Local Institution - 575 Athens Attica
Local Institution - 580 Thessaloniki North Aegean
Local Institution - 579 Haidari - Athens Pella
Local Institution - 576 Thessaloniki Greece
Local Institution - 581 Thessaloniki Greece
Local Institution - 625 Jerusalem Jerusalem
Local Institution - 629 Haifa Tel Aviv
Local Institution - 628 Tel Aviv Tel Aviv
Local Institution - 627 Haifa Israel
Local Institution - 626 Tel Aviv Israel
Local Institution - 778 Pesaro Pesaro E Urbino
Local Institution - 777 Novara Piedmont
Local Institution - 780 Candiolo Torino
Local Institution - 779 Milan Italy

+ 58 more sites — see the full list on the official registry below.

More Mirati Therapeutics Inc. trials in Turkey

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05853575 on ClinicalTrials.gov ↗ ← All trials in Turkey