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Non-small Cell Lung CancerPhase 2NCT04484142

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

A Phase 2 study testing DS-1062a in people with Non-small Cell Lung Cancer, run by Daiichi Sankyo at 84 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-small Cell Lung Cancer
What is being tested?
DS-1062a
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
137 participants
Where
84 sitesin 10 countries
Study dates
30 Mar 2021to 4 Feb 2026
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants eligible for inclusion in the study must meet all inclusion criteria for this study.
  • 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.
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  • 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).
  • Has been treated with 1 or more lines of non-CPI targeted therapy that is locally approved for the participant's applicable genomic alteration at the time of screening:
  • Those who received a targeted agent for the applicable genomic alterations in the study 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 targeted therapy for the same genomic alterations (which may or may not be same agent used in the adjuvant setting) for relapsed/progressive disease.
  • Participants who have been treated with a prior TKI must receive additional targeted therapy, if clinically appropriate, for the genomic alterations that are considered amenable or the participant will not be allowed in the study.
  • Must undergo a mandatory pre-treatment tumor biopsy procedure or if available, a tumor biopsy that was recently collected (within 3 months of screening) after completion of the most recent anticancer treatment regimen and that has a minimum of 10 × 4 micron sections or a tissue block equivalent of 10 × 4 micron sections may be substituted for the mandatory biopsy collected during screening.
  • Measurable disease based on local imaging assessment using RECIST v1.1.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 - 1 at screening.

Who cannot join

  • Participants meeting any exclusion criteria for this study will be excluded from this study.
  • 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.
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  • 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.
  • Has other primary malignancies, except adequately resected non-melanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for ≥3 years.

Trial locations and contacts

84 sites in 10 countries.

84 sites in 10 countries

United States28 sites

  • Virginia Cancer Specialists

    Athens, Virginia, 30607

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Sarah Cannon Research Institute at Tennessee Oncology - Chattanooga

    Chattanooga, Tennessee, 37404

  • The Office of Dr. Frederick P. Smith MD

    Chevy Chase, Maryland, 20815

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230

  • University of Michigan

    Detroit, Michigan, 48202

  • XCancer / Regional Cancer Care Associate (Astera)

    East Brunswick, New Jersey, 08816

  • Sarah Cannon Research Institute at Florida Cancer Center, North

    Gainesville, Florida, 32605

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

  • University of California San Diego

    La Jolla, California, 92093

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • NYU Langone Medical Center

    New York, New York, 10016

  • Weill Cornell Medical College

    New York, New York, 10065

  • AdventHealth Orlando

    Orlando, Florida, 32804

  • Mayo Clinic

    Phoenix, Arizona, 85259

  • Sarah Cannon Research Institute at Florida Cancer Center, South

    Port Charlotte, Florida, 33980

  • New York Cancer and Blood Specialists

    Port Jefferson, New York, 11776

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • UCLA

    Santa Monica, California, 90404

  • Seattle Cancer Care Alliance

    Seattle, Washington, 33612

  • Avera Cancer Institute Sioux Falls

    Sioux Falls, South Dakota, 57105

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

Japan14 sites

  • Aichi Cancer Center Hospital

    Aichi, 464-8681

  • National Cancer Center Hospital

    Chuo Ku, Tokyo, 104-0045

  • Kansai Medical University Hospital

    Hirakata-shi, Osaka, 573-1191

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577

  • The Cancer Institute Hospital of JFCR

    Koto-Ku, Tokyo, 135-8550

  • Kyoto University Hospital

    Kyoto, Kyoto, 606-8507

  • Shizuoka Cancer Center

    Nagaizumi-chō, Shizuoka, 411-8777

  • Niigata Cancer Center Hospital

    Niigata, Niigata, 961-8566

  • Osaka City General Hospital

    Osaka, Osaka, 534-0021

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567

  • Kindai University Hospital

    Ōsaka-sayama, Osaka, 589-8511

  • Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804

  • Tokushima University Hospital

    Tokushima, Tokushima, 770-8503

  • Fujita Health University Hospital

    Toyoake-shi, Aichi-ken, 470-1192

Other trials in Japan

France9 sites

  • Centre Leon Berard

    Lyon, Rhone, 69008

  • CHU Louis Pradel

    Lyon, 69003

  • APHM - Hopital Nord

    Marseille, Bouches-Du-Rhône, 13015

  • University Hospital of Nantes

    Nantes, Loire-Atlantique, 44000

  • Institut Curie

    Paris, 75005

  • Hopitaux Universitaire de Strasbourg- Nouvel Hopital Civil

    Strasbourg, 67091

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

    Toulon, 83000

  • CHU Toulouse Hopital Larrey

    Toulouse, Occitanie, 31059

  • Gustav Roussy Cancer Campus Grand Paris

    Villejuif, Île-de-France Region, 94805

Other trials in France

Italy8 sites

  • Azienda Ospedaliero-Universitaria S. Orsola Malpighi

    Bologna, 40138

  • Azienda Ospedaliera Universitaria Policlinico-OVE

    Catania, CT, 95030

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • Istituto Europeo di Oncologia

    Milan, 20141

  • University of Turin San Luigi Hospital

    Orbassano, Torino, 10043

  • Azienda Ospedaliero Universitaria di Parma

    Parma, 43126

  • Azienda Ospedaliera Arcispedale Santa Maria

    Reggio Emilia, 42123

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, RM, 00168

Other trials in Italy

Germany6 sites

  • Universitaet zu Koeln - Uniklinik Koeln

    Cologne, North Rhine-Westphal, 50937

  • IKF Krankenhaus Nordwest

    Frankfurt am Main, Hesse, 60488

  • Asklepios Fachklinik Muenchen-Gauting

    Gauting, Bavaria, 82131

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Thoraxklinik Heidelberg

    Heidelberg, Baden-Wurttemberg, 69126

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg, 69126

Other trials in Germany

Spain6 sites

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital Universitario Vall dHebron

    Barcelona, 08035

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Regional Universitario Malaga

    Málaga, Malaga, 29010

Other trials in Spain

South Korea5 sites

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 110744

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 6273

Other trials in South Korea

Taiwan4 sites

  • National Cheng Kung University Hospital

    Tainan, 70403

  • National Taiwan University Hospital NTUH

    Taipei, 100

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 112

Other trials in Taiwan

Hungary2 sites

  • National Koranyi Institute for TB and Pulmonology

    Budapest, H-1121

  • Pulmonology Hospital Törökbálint

    Törökbálint, H-2045

Other trials in Hungary

Netherlands2 sites

  • The Netherlands Cancer Institute

    Amsterdam, North Holland, 1066 CX

  • Erasmus MC

    Rotterdam, South Holland, 3015 CD

Other trials in Netherlands

About this study

Official title: Phase 2, Single-arm, Open-label Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations and Progressed On or After Applicable Targeted Therapy and Platinum Based Chemotherapy (TROPION-Lung05)

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.

Read the detailed description

This study will evaluate DS-1062a 6.0 mg/kg in participants with advanced or metastatic NSCLC with actionable genomic alterations and who have been previously been treated with 1 platinum-containing therapy and 1 or more lines of targeted therapy. The study will be divided into 3 periods: Screening Period, Treatment Period, and Follow-up Period. The primary analysis of Objective Response Rate (ORR) by blinded Independent Central Review (BICR) will be conducted after all participants either have been followed for at least 9 months after the start of study treatment or have discontinued from the study, whichever occurs first.

Being tested
DS-1062a
Keywords
Metastatic Non-small Cell Lung Cancer, Advanced Metastatic Non-small Cell Lung Cancer, Non-small Cell Lung Cancer, DS-1062a, Datopotamab Deruxtecan
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DS-1062aDrug

    Also called Datopotamab Deruxtecan

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

Study groups in NCT04484142
Study groupRoleWhat they receive
DS-1062a 6.0 mg/kgExperimentalParticipants will receive 6.0 mg/kg of DS-1062a
Receives: Drug: DS-1062a

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (7)

  1. Duration of Response (DOR)

    Measured: From baseline up to approximately 24 months

  2. Progression-free Survival (PFS)

    Measured: From baseline up to approximately 24 months

  3. Overall Survival (OS)

    Measured: From baseline up to approximately 24 months

  4. Pharmacokinetic Parameter Maximum Concentration (Cmax)

    Measured: From baseline up to approximately 24 months

  5. Pharmacokinetic Parameter Time to Maximum Concentration (Tmax)

    Measured: From baseline up to approximately 24 months

  6. Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC)

    Measured: From baseline up to approximately 24 months

  7. Percentage of Participants Who Reported Treatment-emergent Adverse Events (TEAE)

    Measured: From baseline up to approximately 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2020
  2. Study start30 Mar 2021
  3. Primary completion10 Mar 2023
  4. Study completion4 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
137 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04484142
Sponsor's protocol ID
DS1062-A-U202
Other IDs
2020-002774-27, 2024-511449-21-00
Status last verified
Mar 2026
First submitted
20 Jul 2020
Last updated
24 Mar 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/

Publications

  • Ahn MJ, Lisberg A, Goto Y, Sands J, Hong MH, Paz-Ares L, Pons-Tostivint E, Perol M, Felip E, Sugawara S, Hayashi H, Cho BC, Blumenschein G Jr, Shum E, Lee JS, Heist RS, Cornelissen R, Chang WC, Kowalski D, Zebger-Gong H, Chargualaf M, Gu W, Lan L, Howarth P, Joseph R, Okamoto I. A Pooled Analysis of Datopotamab Deruxtecan in Patients With EGFR-Mutated NSCLC. J Thorac Oncol. 2025 Nov;20(11):1669-1682. doi: 10.1016/j.jtho.2025.06.002. Epub 2025 Jun 12.

    PubMed 40516821

  • 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.

    PubMed 39761483

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DS-1062a in people with Non-small Cell Lung Cancer, run by Daiichi Sankyo at 84 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in United States, Japan, France, Italy, Germany and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Objective Response Rate (ORR) Based on Blinded Independent Central Review (BICR) (time frame: From baseline until disease progression, death, or other protocol defined reason, up to approximately 24 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04484142, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.

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