Trial intelligence / Profile preview

Trametinib + Anlotinib + Tislelizumab in KRAS-mutant NSCLC

NCT06456138Phase 2

Key facts

Status: Not yet recruiting
Start: Jul 2024
Primary completion: Jun 2026
Countries: 1
Sponsor: Shanghai Chest Hospital
Modality: Small Molecules, Monoclonal Antibodies

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

Overview

Phase 2, open-label, single-arm trial of trametinib, anlotinib and tislelizumab in non-small cell lung cancer (NSCLC), sponsored by Shanghai Chest Hospital. Primary endpoints: Recommended Phase 2 Dose up to 12 months and Progression-Free Survival up to 18 months. Planned start Jul 2024; status: not yet recruiting.

Design

1 arm

Study design: Non-randomizedOpen-label

Trametinib + Anlotinib + Tislelizumab
Combination therapy with oral Trametinib (daily), oral Anlotinib (D1-14 q3w), and IV Tislelizumab (200mg q3w).

Who it enrols

Patients with locally advanced or metastatic KRAS-mutant NSCLC who have progressed on at least one prior line of standard therapy, with no active brain metastases or other driver mutations.

Endpoints

Primary

Recommended Phase 2 Doseup to 12 months
Progression-Free Survivalup to 18 months

Secondary

Objective Response Rateup to 12 months
Overall Survivalup to 24 months
Duration of Responseup to 18 months
Adverse Eventsup to 24 months

Beyond the preview

Go deeper on NCT06456138.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT06456138.