Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04042701 · ClinicalTrials.gov registry record · Phase 1
DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer
A Phase 1 study of Breast Cancer and Non-Small-Cell Lung Carcinoma, sponsored by Daiichi Sankyo.
- Active
- Registry status
- Phase 1
- Development phase
- 115
- Enrollment target
- 20
- Study locations
NCT04042701: Active Phase 1 study of Breast Cancer and Non-Small-Cell Lung Carcinoma, sponsored by Daiichi Sankyo.
NCT04042701 is a Phase 1 study of Breast Cancer and Non-Small-Cell Lung Carcinoma that is active but no longer recruiting, run by Daiichi Sankyo. The registered enrollment target is 115 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04042701, a Phase 1 study of Breast Cancer and Non-Small-Cell Lung Carcinoma, is active but no longer recruiting, sponsored by Daiichi Sankyo.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 115 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Maximum Tolerated Dose (MTD) or recommended dose expansion (RDE) of DS-8201a (Part1) are based on the occurrence of DLTs.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Trastuzumab deruxtecan (DS-8201a)
Study Locations (20)
Other
- 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
Florida
- Cancer Specialists of North Florida (Cbo) - Jacksonville
- Moffitt Cancer Center - Tampa
- Moffit Cancer Center - Tampa
California
- Univ. of Cali. San Francisco Medical Center - San Francisco
Connecticut
- Yale Cancer Center - New Haven
Maryland
- Center for Cancer & Blood Disorders - Bethesda
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
Missouri
- Siteman Cancer Center-Washington University - St Louis
Pennsylvania
- Fox Chase Cancer Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2020-02-10 |
| Est. Completion | 2027-03-31 |
| Phase | Phase 1 |
What the registry record for NCT04042701 still lists
NCT04042701 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT04042701 names 20 study sites across 9 states, led by Other, Florida, California.
Frequently Asked Questions
What is clinical trial NCT04042701 about?
NCT04042701 is a clinical study titled "DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer". 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.
What is the current status of trial NCT04042701?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 115 participants. The study started on 2020-02-10. Estimated completion is 2027-03-31.
What conditions does trial NCT04042701 study?
This clinical trial studies the following conditions: Breast Cancer, Non-Small-Cell Lung Carcinoma.
What interventions are being tested in trial NCT04042701?
The interventions under investigation include: Pembrolizumab (DRUG), Trastuzumab deruxtecan (DS-8201a) (DRUG).
Who is sponsoring clinical trial NCT04042701?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04042701 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04042701's enrollment target sits among peer trials
115 523rd of 1224 higher than 697 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
VS-6766+Abema+Fulv in Met HR+/HER- BC
RECRUITING · Phase 1
-
KK-LC-1 TCR-T Cell Therapy for Gastric, Breast, Cervical, and Lung Cancer
RECRUITING · Phase 1
-
Focused Ultrasound and Gemcitabine in Breast Cancer
RECRUITING · Phase 1
-
A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies
RECRUITING · Phase 1
-
Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors
RECRUITING · Phase 1
-
A Study of MT-4561 in Patients With Various Advanced Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02346929 · 115 participants · NA
Hematoma Block for Distal Radius Fracture
- NCT03394365 · 115 participants · Phase 3
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
- NCT03907475 · 115 participants · Phase 2
Durvalumab in Combination With Chemotherapy in Treating Patients With Advanced Solid Tumors, DURVA+ Trial
- NCT05086692 · 115 participants · Phase 1
A Beta-only IL-2 ImmunoTherapY Study
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI