Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in South Korea / NCT05687266
Active, not recruiting Phase 3

Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations

NCT05687266 · tracked via the Priya Life Science South Korea tracker
Sponsor
AstraZeneca
Phase
Phase 3
Started
2022-12-29
Last updated
2026-10-09

Condition(s) studied

NSCLC

Investigational drug(s) / intervention(s)

Datopotamab deruxtecan →Durvalumab →Carboplatin →Pembrolizumab →Cisplatin →Pemetrexed →Paclitaxel →

Datopotamab deruxtecan: Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.

Durvalumab: Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.

Carboplatin: Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.

Pembrolizumab: Intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle for a maximum of 35 cycles or 2 years (whichever occurs first).

Cisplatin: Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.

Pemetrexed: Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.

Paclitaxel: Intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.

Study summary

This is a Phase III, randomized, open-label, multicenter, global study to compare the efficacy and safety of Datopotamab Deruxtecan (Dato-DXd) in combination with durvalumab and carboplatin compared with pembrolizumab in combination with histology-specific platinum-based chemotherapy as first-line treatment of adults with stage IIIB, IIIC, or IV NSCLC without actionable genomic alterations (including sensitizing EGFR mutations, and ALK and ROS1 rearrangements).

Eligibility

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
Inclusion: * Participants ≥ 18 years at screening * Histologically or cytologically documented NSCLC that at the time of randomisation is Stage IIIB or IIIC disease not amenable to surgical resection or definitive chemoradiation or Stage IV metastatic disease * Lacks sensitising EGFR tumour tissue mutation and ALK and ROS1 rearrangements and has no documented tumour genomic alterations in NTRK, BRAF, RET, MET or other actionable driver oncogenes with approved and available therapies (actionable genomic alterations). Testing is not required for tumors with squamous histology, with exceptions. * ECOG PS of 0 or 1 * Archival tumour tissue * Has adequate bone marrow reserve and organ function within 7 days before randomization Exclusion: * Mixed small-cell lung cancer and NSCLC histology; sarcomatoid variant of NSCLC * History of another primary malignancy with exceptions * Persistent toxicities caused by previous anti-cancer therapy not yet improved to Grade ≤ 1 or baseline, with exceptions. * Spinal cord compression or clinically or radiologically active brain metastases * History of leptomeningeal carcinomatosis. * Known active or uncontrolled hepatitis B or C virus infection. * Uncontrolled or suspected infection requiring IV antibiotics, antivirals, or antifungals. * Clinically significant corneal disease * History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.

Primary outcome measure(s)

  • Progression-Free Survival (PFS) by blinded independent central review (BICR) in the non-squamous TROP2 biomarker positive population — Approximately 3 years
    PFS is defined as time from randomisation until progression per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) as assessed by BICR, or death due to any cause.
  • Overall Survival (OS) in the non-squamous TROP2 biomarker positive population — Approximately 5 years
    OS is defined as the time from randomisation until the date of death due to any cause.
  • PFS by BICR in the non-squamous population — Approximately 3 years
    PFS is defined as time from randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause.
  • OS in the non-squamous population — Approximately 5 years
    OS is defined as the time from randomisation until the date of death due to any cause.

Trial sites (254)

FacilityCityRegionStatus
Research Site Phoenix Arizona
Research Site Tucson Arizona
Research Site Hot Springs Arkansas
Research Site Little Rock Arkansas
Research Site Springdale Arkansas
Research Site Fountain Valley California
Research Site Los Angeles California
Research Site Orange California
Research Site Boulder Colorado
Research Site Fort Myers Florida
Research Site Jacksonville Florida
Research Site St. Petersburg Florida
Research Site West Palm Beach Florida
Research Site Hinsdale Illinois
Research Site Fort Wayne Indiana
Research Site Bettendorf Iowa
Research Site Iowa City Iowa
Research Site Waukee Iowa
Research Site Baton Rouge Louisiana
Research Site Covington Louisiana
Research Site Duluth Minnesota
Research Site Rochester Minnesota
Research Site Hannibal Missouri
Research Site Lincoln Nebraska
Research Site Lincoln Nebraska
Research Site Clifton Park New York
Research Site Asheville North Carolina
Research Site Canton Ohio
Research Site Columbus Ohio
Research Site Maumee Ohio
Research Site Tulsa Oklahoma
Research Site Portland Oregon
Research Site Salem Oregon
Research Site Philadelphia Pennsylvania
Research Site Philadelphia Pennsylvania
Research Site Philadelphia Pennsylvania
Research Site York Pennsylvania
Research Site Watertown South Dakota
Research Site Memphis Tennessee
Research Site Dallas Texas

+ 214 more sites — see the full list on the official registry below.

On this site

📄 Imfinzi (durvalumab) drug profile → 📄 Keytruda (pembrolizumab) drug profile →

More AstraZeneca trials in South Korea

Savolitinib vs. Sunitinib in MET-driven PRCC. Active, not recruiting
A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus Recruiting
A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations Active, not recruiting
Study of MEDI4736 (Durvalumab) With or Without Tremelimumab Versus Standard of Care Chemotherapy in Urothelial Cancer Active, not recruiting
Study of AZD0120 in Newly Diagnosed Multiple Myeloma Ineligible for ASCT Recruiting

Other trials for the same condition

First-In-Human Study of STX-721/PFL-721 in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Harboring EGFR or HER2 Exon 20 Insertion Mutations Recruiting
Safety, Tolerability, and Preliminary Efficacy of CJRB-101 With Pembrolizumab in Subjects With Selected Types of Advanced or Metastatic Cancer Recruiting
Lazertinib for NSCLC Harboring Activating EGFR Mutations in TKI naïve Patients Active, not recruiting
A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung Cancer Active, not recruiting
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of Enzelkitug as a Single Agent and in Combination With Checkpoint Inhibitor in Participants With Locally Advanced or Metastatic Solid Tumors Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05687266 on ClinicalTrials.gov ↗ ← All trials in South Korea