Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05)

NCT04484142 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: DS1062-A-U2022020-002774-272024-511449-21-00
• Study Type: interventional
• Target: 137
• Locations: 10 countries
• Sites: 84

Brief Summary

This is a study of the efficacy, pharmacokinetics, and safety of DS-1062a in participants with advanced or metastatic non-small cell lung cancer (NSCLC) with known actionable genomic alterations.

Conditions

Non-small Cell Lung Cancer

Keywords

Metastatic Non-small Cell Lung Cancer; Advanced Metastatic Non-small Cell Lung Cancer; Non-small Cell Lung Cancer; DS-1062a; Datopotamab Deruxtecan

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR)

  ORR is defined as the proportion of participants with a best overall response of confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

  From baseline until disease progression, death, or other protocol defined reason, up to approximately 24 months.

Secondary Outcomes (7)

• Duration of Response (DOR)

  From baseline up to approximately 24 months

• Progression-free Survival (PFS)

  From baseline up to approximately 24 months

• Overall Survival (OS)

  From baseline up to approximately 24 months

• Pharmacokinetic Parameter Maximum Concentration (Cmax)

  From baseline up to approximately 24 months

• Pharmacokinetic Parameter Time to Maximum Concentration (Tmax)

  From baseline up to approximately 24 months

Study Arms (1)

DS-1062a 6.0 mg/kg

EXPERIMENTAL

Participants will receive 6.0 mg/kg of DS-1062a

Drug: DS-1062a

Interventions

DS-1062a DRUG

DS-1062a will be administered as an intravenous (IV) infusion once every 3 weeks

Also known as: Datopotamab Deruxtecan

DS-1062a 6.0 mg/kg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sign and date the inform consent form (ICF) prior to the start of any study- specific qualification procedures.
• Adults ≥18 years (if the legal age of consent is \>18 years old, then follow local regulatory requirements)
• Has pathologically documented NSCLC that:
• Has stage IIIB, IIIC, or stage IV NSCLC disease at the time of enrollment (based on the American Joint Committee on Cancer, Eighth Edition).
• Has one or more of the following documented activating genomic alterations: EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, or RET.
• KRAS mutations in the absence of any of the genomic alterations specified above will be excluded.
• Overexpression of EGFR, in the absence of activating mutations, is NOT sufficient for enrollment.
• Participants who have not received osimertinib should be evaluated for the presence of EGFR T790M mutation after relapse/progression on/after the most recent EGFR tyrosine kinase inhibitor (TKI), unless the participant is already known to be positive with document results for this mutation or unless osimertinib is not locally approved.
• Has documentation of radiographic disease progression while on or after receiving the most recent treatment regimen for advanced or metastatic NSCLC.
• Participant must meet the following for advanced or metastatic NSCLC:
• Has been treated with at least one but no more than two cytotoxic agent-containing therapy in the metastatic setting:
• One platinum-containing regimen (either as monotherapy or combination therapy).
• May have received up to one additional line of cytotoxic agent-containing therapy.
• Those who received a platinum-containing regimen as adjuvant therapy for early stage disease must have relapsed or progressed while on the treatment or within 6 months of the last dose OR received at least one additional course of platinum-containing therapy (which may or may not be same as in the adjuvant setting) for relapsed/progressive disease.
• May have received up to one checkpoint inhibitor (CPI)-containing regimen (may be in combination with a cytotoxic agent as part of a regimen described above or as an additional CPI regimen without a cytotoxic agent).

You may not qualify if:

• Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Participants with clinically inactive brain metastases may be included in the study.
• Has leptomeningeal carcinomatosis.
• Has prior treatment with:
• Any chemotherapeutic agent targeting topoisomerase I, including antibody drug conjugate (ADC) containing such agent.
• TROP2-targeted therapy.
• Uncontrolled or significant cardiovascular disease:
• History of myocardial infarction within 6 months prior to Cycle 1 Day 1.
• History of uncontrolled angina pectoris within 6 months prior to Cycle 1 Day 1.
• Symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV) at screening. Participants with a history of Class II to IV CHF prior to screening must have returned to Class I CHF and have LVEF ≥50% (by either an ECHO or MUGA scan within 28 days of Cycle 1 Day 1) in order to be eligible.
• History of serious cardiac arrhythmia requiring treatment.
• LVEF \<50% or institutional lower limit of normal by ECHO or MUGA scan.
• Uncontrolled hypertension (resting systolic blood pressure \>180 mmHg or diastolic blood pressure \>110 mmHg).
• Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
• Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
• Clinically significant corneal disease.

Sponsors & Collaborators

• Daiichi Sankyo: lead
• AstraZeneca: collaborator

Study Sites (84)

Mayo Clinic

Phoenix, Arizona, 85259, United States

Location

University of California San Diego

La Jolla, California, 92093, United States

Location

UCLA

Santa Monica, California, 90404, United States

Location

Boca Raton Regional Hospital

Boca Raton, Florida, 33486, United States

Location

Sarah Cannon Research Institute at Florida Cancer Center, North

Gainesville, Florida, 32605, United States

Location

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

AdventHealth Orlando

Orlando, Florida, 32804, United States

Location

Sarah Cannon Research Institute at Florida Cancer Center, South

Port Charlotte, Florida, 33980, United States

Location

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

The Office of Dr. Frederick P. Smith MD

Chevy Chase, Maryland, 20815, United States

Location

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02114, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Michigan

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

XCancer / Regional Cancer Care Associate (Astera)

East Brunswick, New Jersey, 08816, United States

Location

NYU Langone Medical Center

New York, New York, 10016, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

New York Cancer and Blood Specialists

Port Jefferson, New York, 11776, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Avera Cancer Institute Sioux Falls

Sioux Falls, South Dakota, 57105, United States

Location

Sarah Cannon Research Institute at Tennessee Oncology - Chattanooga

Chattanooga, Tennessee, 37404, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Virginia Cancer Specialists

Athens, Virginia, 30607, United States

Location

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, 99336, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 33612, United States

Location

APHM - Hopital Nord

Marseille, Bouches-Du-Rhône, 13015, France

Location

University Hospital of Nantes

Nantes, Loire-Atlantique, 44000, France

Location

CHU Toulouse Hopital Larrey

Toulouse, Occitanie, 31059, France

Location

Centre Leon Berard

Lyon, Rhone, 69008, France

Location

CHU Louis Pradel

Lyon, 69003, France

Location

Institut Curie

Paris, 75005, France

Location

Hopitaux Universitaire de Strasbourg- Nouvel Hopital Civil

Strasbourg, 67091, France

Location

Centre Hospitalier Intercommunal Toulon La Seyne sur mer Hopital Sainte-Musse

Toulon, 83000, France

Location

Gustav Roussy Cancer Campus Grand Paris

Villejuif, Île-de-France Region, 94805, France

Location

Thoraxklinik Heidelberg

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

Asklepios Fachklinik Muenchen-Gauting

Gauting, Bavaria, 82131, Germany

Location

IKF Krankenhaus Nordwest

Frankfurt am Main, Hesse, 60488, Germany

Location

Universitaet zu Koeln - Uniklinik Koeln

Cologne, North Rhine-Westphal, 50937, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Thoraxklinik Heidelberg gGmbH

Heidelberg, 69126, Germany

Location

National Koranyi Institute for TB and Pulmonology

Budapest, H-1121, Hungary

Location

Pulmonology Hospital Törökbálint

Törökbálint, H-2045, Hungary

Location

Azienda Ospedaliera Universitaria Policlinico-OVE

Catania, CT, 95030, Italy

Location

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, RM, 00168, Italy

Location

University of Turin San Luigi Hospital

Orbassano, Torino, 10043, Italy

Location

Azienda Ospedaliero-Universitaria S. Orsola Malpighi

Bologna, 40138, Italy

Location

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

Milan, 20122, Italy

Location

Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

Azienda Ospedaliero Universitaria di Parma

Parma, 43126, Italy

Location

Azienda Ospedaliera Arcispedale Santa Maria

Reggio Emilia, 42123, Italy

Location

Fujita Health University Hospital

Toyoake-shi, Aichi-ken, 470-1192, Japan

Location

National Cancer Center Hospital East

Kashiwa-shi, Chiba, 277-8577, Japan

Location

Hokkaido Cancer Center

Sapporo, Hokkaido, 003-0804, Japan

Location

Kyoto University Hospital

Kyoto, Kyoto, 606-8507, Japan

Location

Niigata Cancer Center Hospital

Niigata, Niigata, 961-8566, Japan

Location

Kansai Medical University Hospital

Hirakata-shi, Osaka, 573-1191, Japan

Location

Osaka City General Hospital

Osaka, Osaka, 534-0021, Japan

Location

Osaka International Cancer Institute

Osaka, Osaka, 541-8567, Japan

Location

Kindai University Hospital

Ōsaka-sayama, Osaka, 589-8511, Japan

Location

Shizuoka Cancer Center

Nagaizumi-chō, Shizuoka, 411-8777, Japan

Location

Tokushima University Hospital

Tokushima, Tokushima, 770-8503, Japan

Location

National Cancer Center Hospital

Chuo Ku, Tokyo, 104-0045, Japan

Location

The Cancer Institute Hospital of JFCR

Koto-Ku, Tokyo, 135-8550, Japan

Location

Aichi Cancer Center Hospital

Aichi, 464-8681, Japan

Location

The Netherlands Cancer Institute

Amsterdam, North Holland, 1066 CX, Netherlands

Location

Erasmus MC

Rotterdam, South Holland, 3015 CD, Netherlands

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 110744, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 6273, South Korea

Location

Hospital Universitario Puerta de Hierro de Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Hospital Regional Universitario Malaga

Málaga, Malaga, 29010, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital Universitario Vall dHebron

Barcelona, 08035, Spain

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

National Cheng Kung University Hospital

Tainan, 70403, Taiwan

Location

National Taiwan University Hospital NTUH

Taipei, 100, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

Location

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, 112, Taiwan

Location

Related Publications (1)

• Sands J, Ahn MJ, Lisberg A, Cho BC, Blumenschein G Jr, Shum E, Pons Tostivint E, Goto Y, Yoh K, Heist R, Shimizu J, Lee JS, Baas P, Planchard D, Perol M, Felip E, Su WC, Zebger-Gong H, Lan L, Liu C, Howarth P, Chiaverelli R, Paz-Ares L. Datopotamab Deruxtecan in Advanced or Metastatic Non-Small Cell Lung Cancer With Actionable Genomic Alterations: Results From the Phase II TROPION-Lung05 Study. J Clin Oncol. 2025 Apr;43(10):1254-1265. doi: 10.1200/JCO-24-01349. Epub 2025 Jan 6.

  PMID: 39761483 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Contact for Clinical Trial Information
• Organization: Daiichi Sanyko, Inc

CTRinfo@dsi.com

908-992-6400

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: July 23, 2020
• Study Start: March 30, 2021
• Primary Completion: March 10, 2023
• Study Completion: February 4, 2026
• Last Updated: March 24, 2026
• Results First Posted: April 3, 2024

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication
• Access Criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.

Locations

DE (6); KR (5); IT (8); US (28); HU (2); NL (2); JP (14); FR (9); ES (6); TW (4)