Combination Study of RMC-4630 and Sotorasib for NSCLC Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies

Titre officiel

A Phase 2, Open-Label, Multicentre Study of the Combination of RMC-4630 and Sotorasib for Non-Small Cell Lung Cancer Subjects With KRASG12C Mutation After Failure of Prior Standard Therapies

Sommaire:

L’objectif de cette étude est d’évaluer les effets antitumoraux du sotorasib et du RMC-4630 chez des sujets atteints d’un cancer du poumon non à petites cellules (CPNPC) présentant une mutation KRASG12C.

Description de l'essai

Primary Outcome:

• Objective response rate (ORR)

Secondary Outcome:

• Adverse Events
• Serious Adverse Events
• Vital signs
• Clinical laboratory test values
• ECGs Measurements
• Concentration of RMC-4630
• Concentration of sotorasib
• Duration of response (DOR)
• Disease Control Rate (DCR)
• Progression-free survival (PFS)
• Overall survival (OS)

This is a phase 2 multicentre, open-label study evaluating the efficacy, safety, tolerability, and pharmacokinetics (PK) of RMC-4630 in combination with sotorasib in subjects with KRASG12C mutant NSCLC after failure of prior standard therapies.

Voir cet essai sur ClinicalTrials.gov