🏛️ Verified NIH Record • Updated 2025-11-17

DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer (NCT04042701)

A Phase 1b, Multicenter, Two-Part, Open-Label Study of Trastuzumab Deruxtecan (DS-8201a), An Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), In Combination With Pembrolizumab, An Anti-PD-1 Antibody, For Subjects With Locally Advanced/Metastatic Breast Or Non-Small Cell Lung Cancer (NSCLC)

🔵 Active, Not Recruiting Phase1 💊 Investigational Drug / Biologic Sponsor: Daiichi Sankyo

🩺 Plain-English Summary (8th-Grade Level)

This two-part study will include a dose escalation part to determine the recommended dose for expansion of DS8201a and pembrolizumab and a dose expansion part to evaluate efficacy, safety, and tolerability of the combination.

Who can join: Review the eligibility criteria below.

Location: Univ. of Cali. San Francisco Medical Center — San Francisco, California

Age range: 18 Years

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (30 Sites)

Showing the first 25 of 30 sites.

  • Univ. of Cali. San Francisco Medical Center — San Francisco, California
  • Yale Cancer Center — New Haven, Connecticut
  • Cancer Specialists of North Florida (Cbo) — Jacksonville, Florida
  • Moffitt Cancer Center — Tampa, Florida
  • Moffit Cancer Center — Tampa, Florida
  • Center for Cancer & Blood Disorders — Bethesda, Maryland
  • Massachusetts General Hospital Cancer Center — Boston, Massachusetts
  • Siteman Cancer Center-Washington University — St Louis, Missouri
  • Fox Chase Cancer Center — Philadelphia, Pennsylvania
  • Hope Cancer Center of East Texas — Tyler, Texas
  • Institut Bergonie — Bordeaux,
  • Centre Hospitalier Intercommunal de Créteil — Créteil,
  • CHUTimone — Marseille,
  • Institut PAOLI-CALMETTES — Marsielle,
  • CHU de Poitiers — Poitiers,
  • Univ. du Cancer de Toulouse — Toulouse,
  • Institut Gustave Roussy — Villejuif,
  • Hospital Teresa Herrera (C.H.U.A.C) — A Coruña,
  • Inst. Oncologico Baselga Hospital Quiron — Barcelona,
  • Hospital de la Santa Creu i de Sant Pau — Barcelona,
  • Hopital Universitario Insular de Gran Canaria — Las Palmas de Gran Canaria,
  • Hospital General Univ. Gregorio Marañon — Madrid,
  • MD Anderson Cancer Center — Madrid,
  • Hospital Universitario 12 de Octubre — Madrid,
  • Hospital Universitario Virgen Macarena — Seville,

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Breast Cancer clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗