Krystal-7 - A Phase 2 Trial of MRTX849 Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

Studio Clinico

Patologia: Neoplasie del polmone

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: Sì

Fase di studio: II Randomizzato

Linee di trattamento: Prima linea

Criteri di inclusione: 

- Histologically confirmed diagnosis of NSCLC (squamous or nonsquamous) with KRAS G12C mutation and known PD-L1 Tumor Proportion Score (TPS) score.
- Unresectable or metastatic disease.

Criteri di esclusione: 

- Prior systemic treatment for locally advanced or metastatic NSCLC including chemotherapy, immune checkpoint inhibitor therapy, or a therapy targeting KRAS G12C mutation (e.g., AMG 510).
- Active brain metastases.

Schema di trattamento: 

MRTX849 Inhibitor will be administered orally twice daily in a continuous regimen. Pembrolizumab is administered as an intravenous infusion once every 3 weeks (Cohort 1a).

MRTX849 Inhibitor will be administered orally twice daily in a continuous regimen (Cohort 1b).

MRTX849 Inhibitor will be administered orally twice daily in a continuous regimen. Pembrolizumab is administered as an intravenous infusion once every 3 weeks (Cohort 2).

Trattamento sperimentale: 

MRTX849 Monotherapy
MRTX849 in Combination with Pembrolizumab

Trattamento di controllo: 

-

Obiettivi primari dello studio: 

This Phase 2 study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment.

Centri partecipanti

Nord Italia

Centro Italia

Sud Italia e isole

Informazioni Generali

Protocollo

Numero di iscrizione a registro: NCT04613596 - 2020-03101-58

Data di inserimento: 04.08.2022

Promotore

Mirati Therapeutics Inc.

Principal Investigator ITALIA

Istituto Europeo di Oncologia, Milano

Riferimento: Prof. Filippo De Marinis

Telefono: 0257489440

Email: filippo.demarinis@ieo.it

Localita: Milano