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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04656652




Registration number
NCT04656652
Ethics application status
Date submitted
19/11/2020
Date registered
7/12/2020

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)
Scientific title
Phase 3 Randomized Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer (TROPION-LUNG01)
Secondary ID [1] 0 0
2020-004643-80
Secondary ID [2] 0 0
DS1062-A-U301
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Non-small Cell Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS) As Assessed by Blinded Independent Central Review (BICR) Per RECIST v1.1 Following DS-1062a Versus Docetaxel
Timepoint [1] 0 0
From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
Primary outcome [2] 0 0
Overall Survival (OS) Following DS-1062a Versus Docetaxel
Timepoint [2] 0 0
From randomization until date of death due to any cause, up to approximately 43 months
Secondary outcome [1] 0 0
Progression-free Survival (PFS) As Assessed by Investigator Per RECIST v1.1 Following DS-1062a Versus Docetaxel
Timepoint [1] 0 0
From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
Secondary outcome [2] 0 0
Objective Response Rate (ORR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel
Timepoint [2] 0 0
From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
Secondary outcome [3] 0 0
Duration of Response (DOR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel
Timepoint [3] 0 0
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
Secondary outcome [4] 0 0
Disease Control Rate (DCR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel
Timepoint [4] 0 0
From randomization until disease progression or death (whichever occurs first), up to approximately 43 months
Secondary outcome [5] 0 0
Time to Response (TTR) As Assessed by Blinded Independent Central Review (BICR) and Investigator As Per RECIST v1.1 Following DS-1062a Versus Docetaxel
Timepoint [5] 0 0
From randomization to date of first objective response (CR or PR), up to approximately 43 months
Secondary outcome [6] 0 0
Time to Deterioration (TTD) Following DS-1062a Versus Docetaxel
Timepoint [6] 0 0
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
Secondary outcome [7] 0 0
Percentage of Participants Who Reported Treatment-emergent Adverse Events Following DS-1062a Versus Docetaxel
Timepoint [7] 0 0
Baseline up to 35 days after last study dose, up to approximately 43 months
Secondary outcome [8] 0 0
Pharmacokinetic Parameter Maximum Plasma Concentration (Cmax) of DS-1062a, Total Anti-Trophoblast cell surface protein 2 (Anti-TROP2) Antibody, and Active Metabolite MAAA-1181a
Timepoint [8] 0 0
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)
Secondary outcome [9] 0 0
Pharmacokinetic Parameter Time to Maximum Plasma Concentration (Tmax) of DS-1062a, Total Anti-TROP2 Antibody, and Active Metabolite MAAA-1181a
Timepoint [9] 0 0
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)
Secondary outcome [10] 0 0
Pharmacokinetic Parameter Area Under the Plasma Concentration-Time Curve (AUC) of DS-1062a, Total Anti-TROP2 Antibody, and Active Metabolite MAAA-1181a
Timepoint [10] 0 0
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)
Secondary outcome [11] 0 0
Proportion of Participants Who Are Anti-Drug Antibody (ADA)-Positive (Baseline and Post-Baseline) and Proportion of Participants Who Have Treatment-emergent ADA
Timepoint [11] 0 0
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)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/12/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
21/06/2025
Actual
Sample size
Target
590
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 0 0
Blacktown Hosital - Blacktown
Recruitment hospital [3] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [4] 0 0
Macquarie Hospital - North Ryde
Recruitment hospital [5] 0 0
Crown Princess Mary Cancer Centre Westmead Hospital - Sydney
Recruitment hospital [6] 0 0
Southern Medical Day Care Centre - Wollongong
Recruitment postcode(s) [1] 0 0
05042 - Bedford Park
Recruitment postcode(s) [2] 0 0
02148 - Blacktown
Recruitment postcode(s) [3] 0 0
03084 - Heidelberg
Recruitment postcode(s) [4] 0 0
02109 - North Ryde
Recruitment postcode(s) [5] 0 0
2145 - Sydney
Recruitment postcode(s) [6] 0 0
02500 - Wollongong
Recruitment outside Australia
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United States of America
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California
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Roma
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Osaka
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Saitama
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Sendai-shi
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Shiroishi
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Tokushima
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Tokyo
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Toyoake
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Osaka-sayama
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Daegu
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Gyeonggi-do
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Seongnam-si
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Seoul
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Mexico
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Country [124] 0 0
Poland
State/province [124] 0 0
Gdynia
Country [125] 0 0
Poland
State/province [125] 0 0
Lublin
Country [126] 0 0
Poland
State/province [126] 0 0
Olsztyn
Country [127] 0 0
Poland
State/province [127] 0 0
Poznan
Country [128] 0 0
Poland
State/province [128] 0 0
Prabuty
Country [129] 0 0
Poland
State/province [129] 0 0
Slupsk
Country [130] 0 0
Poland
State/province [130] 0 0
Warsaw
Country [131] 0 0
Puerto Rico
State/province [131] 0 0
San Juan
Country [132] 0 0
Romania
State/province [132] 0 0
Baia Mare
Country [133] 0 0
Romania
State/province [133] 0 0
Bucharest
Country [134] 0 0
Romania
State/province [134] 0 0
Bucuresti
Country [135] 0 0
Romania
State/province [135] 0 0
Constanta
Country [136] 0 0
Romania
State/province [136] 0 0
Craiova
Country [137] 0 0
Romania
State/province [137] 0 0
Timisoara
Country [138] 0 0
Russian Federation
State/province [138] 0 0
Kursk
Country [139] 0 0
Russian Federation
State/province [139] 0 0
Moscow
Country [140] 0 0
Russian Federation
State/province [140] 0 0
Novosibirsk
Country [141] 0 0
Russian Federation
State/province [141] 0 0
Saint Petersburg
Country [142] 0 0
Singapore
State/province [142] 0 0
Singapore
Country [143] 0 0
Spain
State/province [143] 0 0
Barcelona
Country [144] 0 0
Spain
State/province [144] 0 0
Madrid
Country [145] 0 0
Spain
State/province [145] 0 0
Málaga
Country [146] 0 0
Spain
State/province [146] 0 0
Ourense
Country [147] 0 0
Spain
State/province [147] 0 0
Sevilla
Country [148] 0 0
Spain
State/province [148] 0 0
Valencia
Country [149] 0 0
Spain
State/province [149] 0 0
Zaragoza
Country [150] 0 0
Switzerland
State/province [150] 0 0
Bern
Country [151] 0 0
Switzerland
State/province [151] 0 0
Saint Gallen
Country [152] 0 0
Switzerland
State/province [152] 0 0
Zürich
Country [153] 0 0
Taiwan
State/province [153] 0 0
Kaohsiung City
Country [154] 0 0
Taiwan
State/province [154] 0 0
Niaosong
Country [155] 0 0
Taiwan
State/province [155] 0 0
Taichung
Country [156] 0 0
Taiwan
State/province [156] 0 0
Tainan
Country [157] 0 0
Taiwan
State/province [157] 0 0
Taipei
Country [158] 0 0
Taiwan
State/province [158] 0 0
Taoyuan
Country [159] 0 0
United Kingdom
State/province [159] 0 0
London
Country [160] 0 0
United Kingdom
State/province [160] 0 0
Manchester
Country [161] 0 0
United Kingdom
State/province [161] 0 0
Middlesbrough

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Daiichi Sankyo
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
AstraZeneca
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Leader
Address 0 0
Daiichi Sankyo
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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/

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/daiichi-sankyo/


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04656652