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New hope for tough lung cancers: DS-1062a shows promise in early trial

NCT ID NCT04484142

Disease control Sponsor: Daiichi Sankyo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tested the drug DS-1062a in 137 adults with advanced or metastatic non-small cell lung cancer that has specific genetic changes and has worsened after targeted therapy and chemotherapy. The main goal was to see how many patients' tumors shrank or disappeared. The study also looked at how long the response lasted, survival, and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DS-1062a (Datopotamab Deruxtecan)
What this could lead to
If successful, this could provide a new treatment option for people with advanced lung cancer who have not responded to other therapies.
What could go wrong
This is a small, early-phase trial without a comparison group, so results may not confirm effectiveness. Side effects from the drug could also limit its use.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

137 people

The number who actually took part.

Started

Mar 2021

Finished

Feb 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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: 1. Has stage IIIB, IIIC, or stage IV NSCLC disease at the time of enrollment (based on the American Joint Committee on Cancer, Eighth Edition). 2. 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: 1. 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. 2. 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). 3. 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. Exclusion Criteria: 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: 1. Any chemotherapeutic agent targeting topoisomerase I, including antibody drug conjugate (ADC) containing such agent. 2. TROP2-targeted therapy. * Uncontrolled or significant cardiovascular disease: 1. History of myocardial infarction within 6 months prior to Cycle 1 Day 1. 2. History of uncontrolled angina pectoris within 6 months prior to Cycle 1 Day 1. 3. 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. 4. History of serious cardiac arrhythmia requiring treatment. 5. LVEF \<50% or institutional lower limit of normal by ECHO or MUGA scan. 6. 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.

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Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-small cell lung cancer

Contacts and locations

Locations

  • APHM - Hopital Nord

    Marseille, Bouches-Du-Rhône, 13015, France

  • AdventHealth Orlando

    Orlando, Florida, 32804, United States

  • Aichi Cancer Center Hospital

    Aichi, 464-8681, Japan

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Asklepios Fachklinik Muenchen-Gauting

    Gauting, Bavaria, 82131, Germany

  • Avera Cancer Institute Sioux Falls

    Sioux Falls, South Dakota, 57105, United States

  • Azienda Ospedaliera Arcispedale Santa Maria

    Reggio Emilia, 42123, Italy

  • Azienda Ospedaliera Universitaria Policlinico-OVE

    Catania, CT, 95030, Italy

  • Azienda Ospedaliero Universitaria di Parma

    Parma, 43126, Italy

  • Azienda Ospedaliero-Universitaria S. Orsola Malpighi

    Bologna, 40138, Italy

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486, United States

  • CHU Louis Pradel

    Lyon, 69003, France

  • CHU Toulouse Hopital Larrey

    Toulouse, Occitanie, 31059, France

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

    Toulon, 83000, France

  • Centre Leon Berard

    Lyon, Rhone, 69008, France

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Erasmus MC

    Rotterdam, South Holland, 3015 CD, Netherlands

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, RM, 00168, Italy

  • Fujita Health University Hospital

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

  • Gustav Roussy Cancer Campus Grand Paris

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

  • Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804, Japan

  • Hopitaux Universitaire de Strasbourg- Nouvel Hopital Civil

    Strasbourg, 67091, France

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036, Spain

  • Hospital General Universitario de Alicante

    Alicante, 03010, Spain

  • Hospital Regional Universitario Malaga

    Málaga, Malaga, 29010, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Puerta de Hierro de Majadahonda

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Vall dHebron

    Barcelona, 08035, Spain

  • IKF Krankenhaus Nordwest

    Frankfurt am Main, Hesse, 60488, Germany

  • Institut Curie

    Paris, 75005, France

  • Istituto Europeo di Oncologia

    Milan, 20141, Italy

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336, United States

  • Kansai Medical University Hospital

    Hirakata-shi, Osaka, 573-1191, Japan

  • Kindai University Hospital

    Ōsaka-sayama, Osaka, 589-8511, Japan

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 112, Taiwan

  • Kyoto University Hospital

    Kyoto, Kyoto, 606-8507, Japan

  • Mary Crowley Cancer Research

    Dallas, Texas, 75230, United States

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    Phoenix, Arizona, 85259, United States

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • NYU Langone Medical Center

    New York, New York, 10016, United States

  • National Cancer Center Hospital

    Chuo Ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Cheng Kung University Hospital

    Tainan, 70403, Taiwan

  • National Koranyi Institute for TB and Pulmonology

    Budapest, H-1121, Hungary

  • National Taiwan University Hospital NTUH

    Taipei, 100, Taiwan

  • New York Cancer and Blood Specialists

    Port Jefferson, New York, 11776, United States

  • Niigata Cancer Center Hospital

    Niigata, Niigata, 961-8566, Japan

  • Osaka City General Hospital

    Osaka, Osaka, 534-0021, Japan

  • Osaka International Cancer Institute

    Osaka, Osaka, 541-8567, Japan

  • Pulmonology Hospital Törökbálint

    Törökbálint, H-2045, Hungary

  • Samsung Medical Center

    Seoul, 6273, South Korea

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Sarah Cannon Research Institute at Florida Cancer Center, North

    Gainesville, Florida, 32605, United States

  • Sarah Cannon Research Institute at Florida Cancer Center, South

    Port Charlotte, Florida, 33980, United States

  • Sarah Cannon Research Institute at Tennessee Oncology - Chattanooga

    Chattanooga, Tennessee, 37404, United States

  • Seattle Cancer Care Alliance

    Seattle, Washington, 33612, United States

  • Seoul National University Bundang Hospital

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

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital

    Seoul, 03722, South Korea

  • Shizuoka Cancer Center

    Nagaizumi-chō, Shizuoka, 411-8777, Japan

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • The Cancer Institute Hospital of JFCR

    Koto-Ku, Tokyo, 135-8550, Japan

  • The Netherlands Cancer Institute

    Amsterdam, North Holland, 1066 CX, Netherlands

  • The Office of Dr. Frederick P. Smith MD

    Chevy Chase, Maryland, 20815, United States

  • Thoraxklinik Heidelberg

    Heidelberg, Baden-Wurttemberg, 69126, Germany

  • Thoraxklinik Heidelberg gGmbH

    Heidelberg, 69126, Germany

  • Tokushima University Hospital

    Tokushima, Tokushima, 770-8503, Japan

  • UCLA

    Santa Monica, California, 90404, United States

  • Universitaet zu Koeln - Uniklinik Koeln

    Cologne, North Rhine-Westphal, 50937, Germany

  • University Hospital of Nantes

    Nantes, Loire-Atlantique, 44000, France

  • University Hospitals Case Medical Center

    Cleveland, Ohio, 44106, United States

  • University of California San Diego

    La Jolla, California, 92093, United States

  • University of Michigan

    Detroit, Michigan, 48202, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • University of Turin San Luigi Hospital

    Orbassano, Torino, 10043, Italy

  • Virginia Cancer Specialists

    Athens, Virginia, 30607, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Weill Cornell Medical College

    New York, New York, 10065, United States

  • XCancer / Regional Cancer Care Associate (Astera)

    East Brunswick, New Jersey, 08816, United States

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Other studies related to the condition(s) this trial covers.