Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation
Phase 3 – large-scale trial before approval
Conditions:
Metastatic Non Small Cell Lung Cancer
Advanced Non Small Cell Lung Cancer
Sponsor: Mirati Therapeutics Inc.
trial.available_in:
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Overview
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.
Who can participate
Inclusion Criteria:
* Histologically or cytologically confirmed diagnosis of NSCLC with KRAS G12C mutation.
* Candidacy to receive treatment with docetaxel.
Crossover Inclusion Criteria:
* Evidence of RECIST 1.1 defined disease progression on docetaxel per BICR
* ECOG performance status 0-2
Exclusion Criteria:
* Prior treatment with an agent targeting KRAS G12C (e.g., AMG 510, Sotorasib).
* Active brain metastases.
Crossover Exclusion Criteria:
* Receipt of any other systemic anti-cancer therapy after last administration of docetaxel on the study.
Locations
21
Australia (1)
Local Institution - 012-016
Mackay , Queensland
Belgium (1)
Universitair Ziekenhuis Brussel
Brussels
Czech Republic (1)
Local Institution - 012-164
Hořovice
France (1)
Local Institution - 012-191-A
Pierre-Bénite , Auvergne-Rhône-Alpes
Germany (1)
Local Institution - 012-219
Bad Berka
Greece (1)
Henry Dunant Hospital Center
Athens , Attica
Hong Kong (1)
Humanity & Health Clinical Trial Centre
Central
Hungary (1)
Local Institution - 012-242
Budapest
Ireland (1)
The Meath Foundation
Tallaght , Dublin
Italy (1)
Local Institution - 012-276
Alessandria
Netherlands (1)
Local Institution - 012-306
Amsterdam
Poland (1)
Instytut MSF
Lodz
Puerto Rico (1)
Puerto Rico Medical Research Center
San Juan
Romania (1)
Spitalul Jude�ean de Urgen�a dr. Constantin Opri� Baia Mare
Baia Mare
Russia (1)
Evimed Oncology Clinic
Chelyabinsk
Singapore (1)
Local Institution - 012-093
Singapore
South Korea (1)
Local Institution - 012-111
Busan
Spain (1)
Clinica Universidad de Navarra - Pamplona
Pamplona , Navarre
Switzerland (1)
Universitatsspital Basel
Basel
United Kingdom (1)
University Hospitals Birmingham NHS Foundation Trust
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