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

March 20, 2026 updated by: Daiichi Sankyo

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
137

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69003
        • CHU Louis Pradel
      • Paris, France, 75005
        • Institut Curie
      • Strasbourg, France, 67091
        • Hopitaux Universitaire de Strasbourg- Nouvel Hopital Civil
      • Toulon, France, 83000
        • Centre Hospitalier Intercommunal Toulon La Seyne sur mer Hopital Sainte-Musse
    • Bouches-Du-Rhône
      • Marseille, Bouches-Du-Rhône, France, 13015
        • APHM - Hopital Nord
    • Loire-Atlantique
      • Nantes, Loire-Atlantique, France, 44000
        • University Hospital of Nantes
    • Occitanie
      • Toulouse, Occitanie, France, 31059
        • CHU Toulouse Hopital Larrey
    • Rhone
      • Lyon, Rhone, France, 69008
        • Centre Leon Berard
    • Île-de-France Region
      • Villejuif, Île-de-France Region, France, 94805
        • Gustav Roussy Cancer Campus Grand Paris
  • Germany
      • Hanover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Heidelberg, Germany, 69126
        • Thoraxklinik Heidelberg gGmbH
    • Baden-Wurttemberg
      • Heidelberg, Baden-Wurttemberg, Germany, 69126
        • Thoraxklinik Heidelberg
    • Bavaria
      • Gauting, Bavaria, Germany, 82131
        • Asklepios Fachklinik Muenchen-Gauting
    • Hesse
      • Frankfurt am Main, Hesse, Germany, 60488
        • IKF Krankenhaus Nordwest
    • North Rhine-Westphal
      • Cologne, North Rhine-Westphal, Germany, 50937
        • Universitaet zu Koeln - Uniklinik Koeln
  • Hungary
      • Budapest, Hungary, H-1121
        • National Koranyi Institute for TB and Pulmonology
      • Törökbálint, Hungary, H-2045
        • Pulmonology Hospital Torokbalint
  • Italy
      • Bologna, Italy, 40138
        • Azienda Ospedaliero-Universitaria S. Orsola Malpighi
      • Milan, Italy, 20141
        • Istituto Europeo Di Oncologia
      • Milan, Italy, 20122
        • Fondazione IRCCS CA Granda Ospedale Maggiore Policlinico
      • Parma, Italy, 43126
        • Azienda Ospedaliero Universitaria di Parma
      • Reggio Emilia, Italy, 42123
        • Azienda Ospedaliera Arcispedale Santa Maria
    • CT
      • Catania, CT, Italy, 95030
        • Azienda Ospedaliera Universitaria Policlinico-OVE
    • RM
      • Rome, RM, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    • Torino
      • Orbassano, Torino, Italy, 10043
        • University of Turin San Luigi Hospital
  • Japan
      • Aichi, Japan, 464-8681
        • Aichi Cancer Center Hospital
    • Aichi-ken
      • Toyoake-shi, Aichi-ken, Japan, 470-1192
        • Fujita Health University Hospital
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 277-8577
        • National Cancer Center Hospital East
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 003-0804
        • Hokkaido Cancer Center
    • Kyoto
      • Kyoto, Kyoto, Japan, 606-8507
        • Kyoto University Hospital
    • Niigata
      • Niigata, Niigata, Japan, 961-8566
        • Niigata Cancer Center Hospital
    • Osaka
      • Hirakata-shi, Osaka, Japan, 573-1191
        • Kansai Medical University Hospital
      • Osaka, Osaka, Japan, 541-8567
        • Osaka International Cancer Institute
      • Osaka, Osaka, Japan, 534-0021
        • Osaka City General Hospital
      • Ōsaka-sayama, Osaka, Japan, 589-8511
        • Kindai University Hospital
    • Shizuoka
      • Nagaizumi-chō, Shizuoka, Japan, 411-8777
        • Shizuoka Cancer Center
    • Tokushima
      • Tokushima, Tokushima, Japan, 770-8503
        • Tokushima University Hospital
    • Tokyo
      • Chuo Ku, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital
      • Koto-Ku, Tokyo, Japan, 135-8550
        • The Cancer Institute Hospital Of JFCR
  • Netherlands
    • North Holland
      • Amsterdam, North Holland, Netherlands, 1066 CX
        • the Netherlands Cancer Institute
    • South Holland
      • Rotterdam, South Holland, Netherlands, 3015 CD
        • Erasmus MC
  • South Korea
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 05505
        • Asan Medical Center
      • Seoul, South Korea, 03722
        • Severance Hospital
      • Seoul, South Korea, 6273
        • Samsung Medical Center
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 110744
        • Seoul National University Bundang Hospital
  • Spain
      • Alicante, Spain, 03010
        • Hospital General Universitario de Alicante
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial de Barcelona
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall Dhebron
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro de Majadahonda
    • Malaga
      • Málaga, Malaga, Spain, 29010
        • Hospital Regional Universitario Malaga
  • Taiwan
      • Tainan, Taiwan, 70403
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 112
        • Koo Foundation Sun Yat-Sen Cancer Center
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital NTUH
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85259
        • Mayo Clinic
    • California
      • La Jolla, California, United States, 92093
        • University of California San Diego
      • Santa Monica, California, United States, 90404
        • UCLA
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Boca Raton Regional Hospital
      • Gainesville, Florida, United States, 32605
        • Sarah Cannon Research Institute at Florida Cancer Center, North
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
      • Orlando, Florida, United States, 32804
        • AdventHealth Orlando
      • Port Charlotte, Florida, United States, 33980
        • Sarah Cannon Research Institute at Florida Cancer Center, South
      • Tampa, Florida, United States, 33612
        • Moffitt Cancer Center
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • The Office of Dr. Frederick P. Smith MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital Cancer Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • University of Michigan
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Jersey
      • East Brunswick, New Jersey, United States, 08816
        • XCancer / Regional Cancer Care Associate (Astera)
    • New York
      • New York, New York, United States, 10065
        • Weill Cornell Medical College
      • New York, New York, United States, 10016
        • NYU Langone Medical Center
      • Port Jefferson, New York, United States, 11776
        • New York Cancer and Blood Specialists
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Cancer Institute Sioux Falls
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Sarah Cannon Research Institute at Tennessee Oncology - Chattanooga
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Dallas, Texas, United States, 75230
        • Mary Crowley Cancer Research
      • Houston, Texas, United States, 77030
        • University of Texas MD Anderson Cancer Center
    • Virginia
      • Athens, Virginia, United States, 30607
        • Virginia Cancer Specialists
    • Washington
      • Kennewick, Washington, United States, 99336
        • Kadlec Clinic Hematology and Oncology
      • Seattle, Washington, United States, 33612
        • Seattle Cancer Care Alliance

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: DS-1062a 6.0 mg/kg
Participants will receive 6.0 mg/kg of DS-1062a
Drug: DS-1062a
DS-1062a will be administered as an intravenous (IV) infusion once every 3 weeks
Other Names:
  • Datopotamab Deruxtecan

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Duration of Response (DOR)
Time Frame: From baseline up to approximately 24 months
From baseline up to approximately 24 months
Progression-free Survival (PFS)
Time Frame: From baseline up to approximately 24 months
From baseline up to approximately 24 months
Overall Survival (OS)
Time Frame: From baseline up to approximately 24 months
From baseline up to approximately 24 months
Pharmacokinetic Parameter Maximum Concentration (Cmax)
Time Frame: From baseline up to approximately 24 months
From baseline up to approximately 24 months
Pharmacokinetic Parameter Time to Maximum Concentration (Tmax)
Time Frame: From baseline up to approximately 24 months
From baseline up to approximately 24 months
Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC)
Time Frame: From baseline up to approximately 24 months
From baseline up to approximately 24 months
Percentage of Participants Who Reported Treatment-emergent Adverse Events (TEAE)
Time Frame: From baseline up to approximately 24 months
From baseline up to approximately 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daiichi Sankyo

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Global Clinical Leader, Daiichi Sankyo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 10, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 4, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 20, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 23, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DS1062-A-U202
  • 2020-002774-27 (EudraCT Number)
  • 2024-511449-21-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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/

IPD Sharing 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

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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