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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04656652
Registration number
NCT04656652
Ethics application status
Date submitted
19/11/2020
Date registered
7/12/2020
Date last updated
21/05/2024
Titles & IDs
Public title
Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01)
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Scientific title
Phase 3 Randomized Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-LUNG01)
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Secondary ID [1]
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2020-004643-80
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Secondary ID [2]
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DS1062-A-U301
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - DS-1062a
Treatment: Drugs - Docetaxel
Experimental: DS-1062a 6.0 mg/kg - Participants will be randomized to receive 6.0 mg/kg of DS-1062a.
Active Comparator: Docetaxel 75 mg/m^2 - Participants will be randomized to receive 75 mg/m^2 docetaxel.
Treatment: Drugs: DS-1062a
DS-1062a will be administered as an intravenous (IV) infusion on Day 1 of each 3-week cycle
Treatment: Drugs: Docetaxel
Docetaxel will be administered as an IV infusion on Day 1 of each 3-week cycle.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR) Per RECIST v1.1 Following DS-1062a Versus Docetaxel
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Assessment method [1]
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PFS is defined as the time from randomization to the earlier of the dates of the first documentation of radiographic progressive disease or death due to any cause.
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Timepoint [1]
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From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
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Primary outcome [2]
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Overall Survival (OS) Following DS-1062a Versus Docetaxel
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Assessment method [2]
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OS is defined as the time from randomization to the date of death due to any cause.
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Timepoint [2]
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From randomization until date of death due to any cause, up to approximately 43 months
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Secondary outcome [1]
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Progression-free Survival (PFS) As Assessed by Investigator Per RECIST v1.1 Following DS-1062a Versus Docetaxel
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Assessment method [1]
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PFS is defined as the time from randomization to the earlier of the dates of the first documentation of radiographic progressive disease or death due to any cause.
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Timepoint [1]
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From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
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Secondary outcome [2]
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Objective Response Rate (ORR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel
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Assessment method [2]
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ORR is defined as the proportion of participants with a best overall response of complete response (CR) or partial response (PR).
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Timepoint [2]
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From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
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Secondary outcome [3]
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Duration of Response (DOR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel
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Assessment method [3]
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DOR is defined as the time from the date of the first documentation of objective response (confirmed CR or confirmed PR) to the date of the first documentation of radiographic PD or death due to any cause, whichever occurs first.
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Timepoint [3]
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From date of first objective response (CR or PR) to date of first radiographic disease progression or death due to any cause (whichever occurs first), up to approximately 43 months
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Secondary outcome [4]
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Disease Control Rate (DCR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel
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Assessment method [4]
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DCR is defined as the proportion of participants who achieved a best overall response (BOR) of CR, PR, or stable disease (SD).
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Timepoint [4]
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From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
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Secondary outcome [5]
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Time to Response (TTR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel
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Assessment method [5]
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TTR is defined as the time from randomization to the date of the first documentation of objective response (CR or PR) in responding participants.
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Timepoint [5]
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From randomization to date of first objective response (CR or PR), up to approximately 43 months
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Secondary outcome [6]
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Time to Deterioration (TTD) Following DS-1062a Versus Docetaxel
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Assessment method [6]
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TTD is defined as the time from randomization to the first onset of a =10-point increase in cough, chest pain, or dyspnea, confirmed by a second =10-point increase from randomization in the same symptom at the next scheduled assessment, or confirmed by death within 21 days of the first =10-point increase from randomization.
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Timepoint [6]
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Baseline and assessed on Day 15 of each cycle until disease progression or end of treatment (each cycle is 21 days) and then once more at +90 days end of treatment
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Secondary outcome [7]
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Percentage of Participants Who Reported Treatment-emergent Adverse Events Following DS-1062a Versus Docetaxel
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Assessment method [7]
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Reported treatment-emergent adverse events, serious adverse events, adverse events of special interest, and those considered related to the study drug or study procedures, or that are associated with study treatment reduction, interruption, or discontinuation.
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Timepoint [7]
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Baseline up to 35 days after last study dose, up to approximately 43 months
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Secondary outcome [8]
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Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of DS-1062a, Total Anti-Trophoblast cell surface protein 2 (Anti-TROP2) Antibody, and Active Metabolite MAAA-1181a
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Assessment method [8]
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Timepoint [8]
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Cycle 1, Day 1: predose and 30 minutes, 3 hours, 5 hours, and 7 hours postdose and Days 2, 4, 8, and 15; Cycles 2, 3, 4, 6, and 8, Day 1: predose and 1 hour postdose (each cycle is 21 days)
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Secondary outcome [9]
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Pharmacokinetic Parameter Time to Maximum Plasma Concentration (Tmax) of DS-1062a, Total Anti-TROP2 Antibody, and Active Metabolite MAAA-1181a
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Assessment method [9]
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Timepoint [9]
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Cycle 1, Day 1: predose and 30 minutes, 3 hours, 5 hours, and 7 hours postdose and Days 2, 4, 8, and 15; Cycles 2, 3, 4, 6, and 8, Day 1: predose and 1 hour postdose (each cycle is 21 days)
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Secondary outcome [10]
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Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve (AUC) of DS-1062a, Total Anti-TROP2 Antibody, and Active Metabolite MAAA-1181a
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Assessment method [10]
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Area under the plasma concentration-time curve up to last quantifiable time (AUClast) and area under the plasma concentration-time curve during dosing interval (AUCtau) will be assessed.
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Timepoint [10]
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Cycle 1, Day 1: predose and 30 minutes, 3 hours, 5 hours, and 7 hours postdose and Days 2, 4, 8, and 15; Cycles 2, 3, 4, 6, and 8, Day 1: predose and 1 hour postdose (each cycle is 21 days)
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Secondary outcome [11]
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Proportion of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Proportion of Participants Who Have Treatment-emergent ADA
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Assessment method [11]
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Timepoint [11]
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Cycle 1, Day 1 predose; Cycle 1, Day 8; Cycles 2, 4, and subsequent cycles, Day 1 predose; end of treatment; 28-day safety follow up; and long-term survival follow up every 3 months, up to approximately 43 months (each cycle is 21 days)
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Eligibility
Key inclusion criteria
Participants eligible for inclusion in the study must meet all inclusion criteria within 28
days of randomization into the 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)
- Life expectancy =3 months
- Has pathologically documented Stage IIIB, IIIC, or stage IV NSCLC disease with or
without actionable genomic alterations (AGA) at the time of randomization (based on
the American Joint Committee on Cancer, Eighth Edition) and meets following criteria
for NSCLC:
- Participants without AGA:
1. Must have documented negative test results for epidermal growth factor receptor
(EGFR) and anaplastic lymphoma kinase (ALK).
2. Must have no known genomic alterations in ROS proto-oncogene 1 (ROS1),
neurotrophic tyrosine receptor kinase (NTRK), proto oncogene B-raf (BRAF),
mesenchymal-epithelial transition (MET) exon 14 skipping, or rearranged during
transfection (RET).
- Participants with AGA must have one or more documented actionable genomic
alteration(s): EGFR, ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, or RET.
- Has documentation of radiographic disease progression while on or after receiving the
most recent treatment regimen for advanced or metastatic NSCLC.
- Participant without AGA must meet 1 of the following prior therapy requirements for
advanced or metastatic NSCLC:
1. Received platinum-based chemotherapy in combination with a-PD-1/a-PD-L1
monoclonal antibody as the only prior line of therapy.
- Includes participants who received prior platinum-based/chemotherapy with or
without radiotherapy with maintenance a-PD-1/a-PD-L1 monoclonal antibody for
Stage III disease and relapsed/progressed within 6 months from the last dose
of platinum-based chemotherapy.
- Includes participants who received prior platinum-based/chemotherapy with or
without radiotherapy (with or without maintenance a-PD-1/a-PD-L1 monoclonal
antibody) for Stage III disease and subsequently received a-PD-1/a-PD-L1
monoclonal antibody therapy (with or without platinum-based chemotherapy)
for recurrent disease.
2. Received platinum-based chemotherapy and a-PD-1/a-PD-L1 monoclonal antibody (in
either order) sequentially as the only 2 prior lines of therapy.
- Participants with AGA must meet the following for advanced or metastatic NSCLC:
1. Participants who have been treated with 1 or 2 prior lines of applicable targeted
therapy that is locally approved for the participant's genomic alteration at the
time of screening;
- Participants who have tumors with EGFR L858R or exon 19 deletion mutations
must have received prior Osimertinib.
- Those who received a targeted agent 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 alteration (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
approved targeted therapy, if locally available and clinically appropriate,
for the applicable genomic alteration, or the participant will not be
allowed in the study.
2. Participants who have received platinum-based chemotherapy as the only prior line
of cytotoxic therapy:
- One platinum-containing regimen for advanced disease
- 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.
3. May have received up to one a-PD-1/a-PD-L1 monoclonal antibody alone or in
combination with a cytotoxic agent.
- Must undergo a pre-treatment tumor biopsy procedure or if available, tumor tissue
previously retrieved from a biopsy procedure performed within 2 years prior to the
participant signing informed consent 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
pre-treatment biopsy procedure during Screening. If a documented law or regulation
prohibits (or does not approve) sample collection, then such samples will not be
collected/submitted
- Measurable disease based on local imaging assessment using RECIST v1.1
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening
- Within 7 days before randomization, has adequate bone marrow, hepatic, and renal
function
- Left ventricular ejection fraction (LVEF) =50% by either echocardiogram (ECHO) or
multigated acquisition (MUGA) scan within 28 days before randomization
- Adequate blood clotting function defined as international normalized ratio/prothrombin
time and either partial thromboplastin or activated partial thromboplastin time =1.5 ×
upper limit of normal (ULN)
- Adequate treatment washout period before randomization
- Females of childbearing potential must have a negative serum pregnancy test at
screening and must be willing to use highly effective birth control from the time of
enrollment up to 7 months after the last dose of DS-1062a or for at least 6 months
after the last dose of docetaxel
- Males must be surgically sterile or must use a condom in addition to highly effective
birth control if his partners are of reproductive potential from the time of
enrollment and for at least 4 months after last dose of DS-1062a or for at least 6
months after the last dose of docetaxel
- Male participants must not freeze or donate sperm from the time of Screening and
throughout the study period and for at least 4 months after the last dose of DS-1062a
or for at least 6 months after the last dose of docetaxel
- Female participants must not donate, or retrieve for their own use, ova from the time
of Screening and throughout the study period and for at least 7 months after the last
dose of DS-1062a and for at least 6 months after the last dose of docetaxel
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Mixed small-cell lung cancer (SCLC) and NSCLC histology
- 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. Participants with treated brain
metastases who are no longer symptomatic and who require no treatment with
corticosteroids or anticonvulsants may be included in the study if they have recovered
from the acute toxic effect of radiotherapy.
- Has leptomeningeal carcinomatosis or metastasis
- Had prior treatment with:
- Any agent including antibody drug conjugate (ADC) containing a chemotherapeutic
agent targeting topoisomerase I
- TROP2-targeted therapy
- Docetaxel
- Had prior treatment with platinum-based chemotherapy and prior immunotherapy for Stage
II NSCLC disease (eg, in the neo-adjuvant or adjuvant setting) without subsequently
meeting the prior therapy requirements for Stage III or metastatic NSCLC disease
- Has NSCLC disease that is eligible for definitive local therapy alone
- Has uncontrolled or significant cardiac disease, including:
- Mean QT interval corrected for heart rate using Fridericia's formula >470 msec
(based on the average of Screening triplicate 12-lead electrocardiogram [ECG]
determinations).
- Myocardial infarction or uncontrolled/unstable angina within 6 months before
randomization
- 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 before randomization) in order to be eligible.
- Uncontrolled or significant cardiac arrhythmia
- LVEF <50% by ECHO or MUGA scan within 28 days before randomization
- Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic
blood pressure >110 mmHg) within 28 days before randomization
- 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
including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli
within 3 months before randomization, severe asthma, severe chronic obstructive
pulmonary disease, restrictive lung disease, pleural effusion, etc.), or any
autoimmune, connective tissue or inflammatory disorders with pulmonary involvement
(ie, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior
pneumonectomy.
- Significant third-space fluid retention (for example ascites or pleural effusion) and
is not amenable for required repeated drainage
- Clinically significant corneal disease
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals; suspected
infections (eg, prodromal symptoms); or inability to rule out infections
- Has known human immunodeficiency virus (HIV) infection that is not well controlled
- Has an active or uncontrolled hepatitis B and/or hepatitis C infection, is positive
for hepatitis B or C virus based on the evaluation of results of tests for hepatitis B
(hepatitis B surface antigen [HBsAg], anti-hepatitis B surface antibody [anti-HBs],
anti-hepatitis B core antibody [anti-HBc], or hepatitis B virus [HBV] DNA), and/or
hepatitis C infection (as per hepatitis C virus [HCV] RNA) within 28 days of
randomization.
- Has a history of malignancy, other than NSCLC, 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
- Toxicities from previous anticancer therapy, defined as toxicities (other than
alopecia) not yet improved to NCI-CTCAE version 5.0 Grade =1 or baseline
- Has a history of severe hypersensitivity reactions to either the drug substances,
inactive ingredients (including but not limited to polysorbate 80) of DS-1062a or
docetaxel, or monoclonal antibodies
- Pregnant or breastfeeding
- Has substance abuse or any other medical conditions such as clinically significant
cardiac or psychological conditions
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
21/12/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
27/06/2024
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Actual
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Sample size
Target
590
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [2]
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Blacktown Hosital - Blacktown
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Recruitment hospital [3]
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Austin Hospital - Heidelberg
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Recruitment hospital [4]
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Macquarie Hospital - North Ryde
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Recruitment hospital [5]
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Crown Princess Mary Cancer Centre Westmead Hospital - Sydney
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Recruitment hospital [6]
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Southern Medical Day Care Centre - Wollongong
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Recruitment postcode(s) [1]
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05042 - Bedford Park
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Recruitment postcode(s) [2]
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02148 - Blacktown
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Recruitment postcode(s) [3]
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03084 - Heidelberg
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Recruitment postcode(s) [4]
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02109 - North Ryde
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Recruitment postcode(s) [5]
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2145 - Sydney
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Recruitment postcode(s) [6]
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02500 - Wollongong
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Florida
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Illinois
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Indiana
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Louisiana
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Maryland
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Massachusetts
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Michigan
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Nevada
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Argentina
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Buenos Aires
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Argentina
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Pergamino
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Rosario
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Haine-Saint-Paul
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Libramont
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Fortaleza
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Beijing
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Hangzhou
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China
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Hangzou
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China
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China
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Henan
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China
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Shanghai
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0
0
China
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Shanxi
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0
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China
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Sichuan Province
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China
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Tianjin
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China
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Wuhan
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China
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Zhejiang
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Czechia
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Praha
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France
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Besançon
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France
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Grenoble
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France
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Lyon
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France
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Marseille
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France
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Nantes
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France
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Paris
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France
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Poitiers
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France
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Rennes
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0
France
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Strasbourg
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0
France
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Sureesnes
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0
France
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Toulouse
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0
France
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Villejuif
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0
Germany
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Berlin
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0
Germany
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Frankfurt am main
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Country [66]
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0
Germany
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Freiburg
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0
Germany
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Gauting
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0
Germany
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Heidelberg
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0
Germany
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Hemer
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Country [70]
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0
Germany
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Kempten
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0
Germany
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Koeln
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0
Germany
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Standort Gießen
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Germany
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Traunstein
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Hong Kong
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Hong Kong
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Hungary
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Budapest
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Hungary
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Tatabánya
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Country [77]
0
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Hungary
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Tolna
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Country [78]
0
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Hungary
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0
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Torokbalint
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Italy
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Bologna
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Italy
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Catania
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Italy
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Genova
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0
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Italy
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Milano
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0
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Italy
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Milan
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0
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Italy
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Orbassano
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Italy
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Roma
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Country [86]
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0
Japan
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State/province [86]
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Akashi
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Country [87]
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0
Japan
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State/province [87]
0
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Chuo Ku
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Country [88]
0
0
Japan
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State/province [88]
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Fukuoka
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Country [89]
0
0
Japan
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State/province [89]
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Hidaka
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Country [90]
0
0
Japan
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State/province [90]
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0
Hirakata
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Country [91]
0
0
Japan
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State/province [91]
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Kanazawa
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Country [92]
0
0
Japan
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State/province [92]
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Kashiwa
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Country [93]
0
0
Japan
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State/province [93]
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0
Koto-Ku
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Country [94]
0
0
Japan
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State/province [94]
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Kyoto
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Country [95]
0
0
Japan
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State/province [95]
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Matsuyama
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Country [96]
0
0
Japan
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State/province [96]
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0
Nagaizumi-cho
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Country [97]
0
0
Japan
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Okayama
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Country [98]
0
0
Japan
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State/province [98]
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Osaka-shi
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Country [99]
0
0
Japan
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Osaka
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Country [100]
0
0
Japan
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0
Saitama
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Country [101]
0
0
Japan
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State/province [101]
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0
Sendai-shi
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Country [102]
0
0
Japan
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State/province [102]
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0
Shiroishi
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Country [103]
0
0
Japan
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0
0
Tokushima
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Country [104]
0
0
Japan
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State/province [104]
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Tokyo
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Country [105]
0
0
Japan
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State/province [105]
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0
Toyoake
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Country [106]
0
0
Japan
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State/province [106]
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0
Osaka-sayama
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Country [107]
0
0
Korea, Republic of
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0
Cheongju-si
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Country [108]
0
0
Korea, Republic of
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State/province [108]
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Daegu
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0
Korea, Republic of
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0
Gyeonggi-do
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Country [110]
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0
Korea, Republic of
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Seongnam-si
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Country [111]
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0
Korea, Republic of
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0
Seoul
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Country [112]
0
0
Mexico
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Aguascalientes
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Mexico
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Ciudad de mexico
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Mexico
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Guadalajara
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Country [115]
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Mexico
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State/province [115]
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Monterrey
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Country [116]
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Netherlands
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Amsterdam
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Netherlands
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Breda
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Netherlands
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Harderwijk
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0
Netherlands
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Rotterdam
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Poland
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Bialystok
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Poland
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Gdynia
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Poland
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Lublin
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Poland
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Poland
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Poznan
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Poland
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Prabuty
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Country [126]
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0
Poland
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Slupsk
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Country [127]
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0
Poland
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Warsaw
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Country [128]
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0
Puerto Rico
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San Juan
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Country [129]
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0
Romania
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Baia Mare
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Country [130]
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Romania
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Bucharest
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Country [131]
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Romania
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Bucuresti
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Country [132]
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Romania
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Constanta
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Country [133]
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Romania
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Craiova
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Romania
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Timisoara
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0
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Russian Federation
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Kursk
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Country [136]
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Russian Federation
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Moscow
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Country [137]
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Russian Federation
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Novosibirsk
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Russian Federation
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Saint Petersburg
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Singapore
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Barcelona
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Country [141]
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Spain
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Madrid
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Country [142]
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Spain
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Málaga
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Country [143]
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Spain
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Ourense
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Country [144]
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Spain
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Sevilla
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Country [145]
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Spain
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Valencia
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Spain
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Zaragoza
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Switzerland
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Bern
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Switzerland
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Saint Gallen
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Switzerland
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Zürich
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Taiwan
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Kaohsiung City
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Taiwan
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Niaosong
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Country [152]
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0
Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Country [156]
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United Kingdom
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London
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Country [157]
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United Kingdom
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Manchester
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Country [158]
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0
United Kingdom
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Middlesbrough
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Daiichi Sankyo
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/Industry
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Name [1]
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0
AstraZeneca
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Address [1]
0
0
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Country [1]
0
0
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will evaluate the efficacy, safety, and pharmacokinetics of DS-1062a versus
docetaxel in participants with previously treated advanced or metastatic non-small cell lung
cancer (NSCLC) with or without actionable genomic alterations.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04656652
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Public notes
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Contacts
Principal investigator
Name
0
0
Global Clinical Leader
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Address
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0
Daiichi Sankyo
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0
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0
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0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04656652
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