OncRef

Clinical Trial: NCT06899126

Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer

Status:

RECRUITING

Phase:

Phase 3

Lead Sponsor:Daiichi Sankyo
Information Provided By:Daiichi Sankyo
Last Update Posted:2026-09-15

Study Overview

Brief Summary

This clinical trial is designed to assess the efficacy and safety of trastuzumab deruxtecan (T-DXd; Enhertu®) in combination with pembrolizumab versus platinum-based chemotherapy in combination with pembrolizumab in participants with no prior therapy for locally advanced unresectable or metastatic non-squamous NSCLC, whose tumors have HER2-overexpressing and PD-L1 TPS <50% without known AGA that have locally available therapies targeting their AGAs in first-line advanced/metastatic setting.

Official Title

A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan in Combination With Pembrolizumab Versus Platinum-based Chemotherapy in Combination With Pembrolizumab, as First-line Therapy in Participants With Locally Advanced Unresectable or Metastatic HER2 Overexpressing and PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer (DESTINY-Lung06)

Conditions

Non-small Cell Lung Cancer

Intervention / Treatment

  • Drug: Trastuzumab Deruxtecan
  • Drug: pembrolizumab
  • Drug: Pemetrexed
  • Drug: Platinum Chemotherapy

Other Study ID Numbers

  • DS8201-793
  • 2024-515658-26-00
  • KEYNOTE-G23
  • MK-3475-G23

Start Date (Actual)

2025-10-24

Primary Completion Date (Estimated)

2030-04-24

Study Completion Date (Estimated)

2032-11-24

Enrollment (Estimated)

686

Study Type

Interventional

Phase

Phase 3