Trial intelligence / Profile preview

Sotorasib in Advanced KRASG12C-mutated NSCLC Patients With Comorbidities

NCT05311709Phase 2

Key facts

Status: Unknown
Start: May 2022
Primary completion: Oct 2024
Countries: 1
Sponsor: Vestre Viken Hospital Trust
Modality: Small Molecules

Drugs: sotorasib
Conditions: non-small cell lung cancer (NSCLC)

Overview

Phase 2, open-label, single-arm trial of sotorasib in non-small cell lung cancer (NSCLC), sponsored by Vestre Viken Hospital Trust. Primary endpoint: Objective Response Rate up to 2 years. Status: unknown.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Sotorasib
Single arm receiving sotorasib

Who it enrols

Adult patients with KRAS G12C-mutated stage III/IV NSCLC who have progressed on at least one prior systemic therapy (including a checkpoint inhibitor). Patients with ECOG PS 0-2 and stable brain metastases are eligible. Specific comorbidities (autoimmune, COPD, cardiovascular) are allowed within defined severity limits.

Endpoints

Primary

Objective Response Rateup to 2 years

Secondary

Objective Response Rate in Predefined Patient Groupsup to 2 years
Evaluation of Efficacy Measured by Tumour Shrinkage8 months
Overall Survival8 months
Time to Progression8 months
EuroQol 5-Dimension 5-Level12 weeks
EORTC QLQ-LC1312 weeks
EORTC QLQ-C3012 weeks
Incidence of Treatment-Emergent Adverse Eventsuntil 28 days after last dose

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