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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05215340




Registration number
NCT05215340
Ethics application status
Date submitted
18/01/2022
Date registered
31/01/2022

Titles & IDs
Public title
Study of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in the First-line Treatment of Subjects With Advanced or Metastatic NSCLC Without Actionable Genomic Alterations
Scientific title
A Randomized, Open-label, Phase 3 Trial of Dato-DXd Plus Pembrolizumab vs Pembrolizumab Alone in Treatment-naïve Subjects With Advanced or Metastatic PD-L1 High (TPS =50%) Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung08)
Secondary ID [1] 0 0
2021-002555-10
Secondary ID [2] 0 0
DS1062-A-U304
Universal Trial Number (UTN)
Trial acronym
TROPION-Lung08
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic 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 - Datopotamab Deruxtecan
Treatment: Drugs - Pembrolizumab

Experimental: Pembrolizumab + Datopotamab Deruxtecan (Dato-DXd) - Participants will be randomized to receive 200 mg pembrolizumab followed by 6.0mg/kg Dato-DXd.

Active comparator: Pembrolizumb - Participants will be randomized to receive 200 mg pembrolizumab.


Treatment: Drugs: Datopotamab Deruxtecan
Dato-DXd will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.

Treatment: Drugs: Pembrolizumab
Pembrolizumab will be administered as an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival Based on Blinded Independent Central Review in Participants With Non-Squamous Histology Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Timepoint [1] 0 0
From randomization until disease progression or death (whichever occurs first), up to approximately 44 months
Primary outcome [2] 0 0
Overall Survival (OS) in Participants With Non-Squamous Histology Who Were Administered Dato-DXd in Combination With Pembrolizumab Compared With Pembrolizumab
Timepoint [2] 0 0
From randomization until date of death due to any cause, up to approximately 71 months
Secondary outcome [1] 0 0
OS in All Randomized Participants, Including Participants With Squamous and Non-Squamous Histology
Timepoint [1] 0 0
From randomization until date of death due to any cause, up to approximately 71 months
Secondary outcome [2] 0 0
PFS Based on BICR in All Randomized Participants, Including Participants With Squamous and Non-Squamous Histology
Timepoint [2] 0 0
From randomization until disease progression or death (whichever occurs first), up to approximately 44 months
Secondary outcome [3] 0 0
Progression-free Survival by Investigator in Participants with Non-Squamous Histology, and Separately for All Randomized Participants
Timepoint [3] 0 0
From randomization until disease progression or death (whichever occurs first), up to approximately 44 months
Secondary outcome [4] 0 0
Progression-free Survival 2 in Participants with Non-Squamous Histology, and Separately for All Randomized Participants
Timepoint [4] 0 0
From randomization until disease progression on the next line of therapy or death (whichever occurs first), up to approximately 71 months
Secondary outcome [5] 0 0
ORR by BICR and Investigator in Participants with Non-Squamous Histology, and Separately for All Randomized Participants
Timepoint [5] 0 0
From randomization to first confirmed response, up to approximately 44 months
Secondary outcome [6] 0 0
Duration of Response by BICR and Investigator in Participants with Non-Squamous Histology, and Separately for All Randomized Participants
Timepoint [6] 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 44 months
Secondary outcome [7] 0 0
Time to Response by BICR and Investigator in Participants with Non-Squamous Histology, and Separately for All Randomized Participants
Timepoint [7] 0 0
From randomization to date of first objective response (CR or PR), up to approximately 44 months
Secondary outcome [8] 0 0
Disease Control Rate by BICR and Investigator in Participants with Non-Squamous Histology, and Separately for All Randomized Participants
Timepoint [8] 0 0
From randomization until disease progression or death (whichever occurs first), up to approximately 44 months
Secondary outcome [9] 0 0
Time to Deterioration in Participants with Non-Squamous Histology, and Separately for All Randomized Participants
Timepoint [9] 0 0
From randomization until disease progression or death (whichever occurs first), up to 71 months
Secondary outcome [10] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAE) with Non-Squamous Histology, and Separately for All Randomized Participants
Timepoint [10] 0 0
Up to 71 months
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 for Participants with Non-Squamous Histology, and Separately for All Randomized Participants
Timepoint [11] 0 0
Baseline and up to 71 months

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 Tissue Screening and Main Informed Consent Forms, prior to the start of any study-specific qualification procedures.
* Adults =18 years or the minimum legal adult age (whichever is greater) at the time of informed consent.
* Histologically documented non-squamous NSCLC that meets all of the following criteria (Note: Subjects with squamous histology were eligible prior to Protocol Version 5.0. After Protocol Version 5.0, subjects with squamous histology are not eligible. Subjects with mixed histology, including those with a squamous component, remain eligible the study even after Protocol Version 5.0):

1. Stage IIIB or IIIC disease and not candidates for surgical resection or definitive chemoradiation, or Stage IV NSCLC disease at the time of randomization (based on the American Joint Committee on Cancer, Eighth Edition). Participants with early-stage NSCLC who have relapsed should be restaged during screening to ensure their eligibility for the study.
2. Documented negative test results for epidermal growth factor receptor (EGFR), lymphoma kinase (ALK), and proto-oncogene1 (ROS1) actionable genomic alterations (AGAs) based on analysis of tumor tissue. If test results for EGFR, ALK, and ROS1 are not available, subjects are required to undergo testing performed locally for these genomic alterations.
3. No known AGAs in neurotrophic tyrosine receptor kinase (NTRK), proto-oncogene B-raf (BRAF), rearranged during transfection (RET), mesenchymal-epithelial transition factor (MET), or other actionable driver kinases with locally approved therapies. (Testing for genomic alterations besides EGFR, ALK, and ROS1 is not required prior to randomization). Subjects whose tumors harbor KRAS mutations are eligible for the study.
* Has provided a formalin-fixed tumor tissue sample for the measurement of trophoblast cell surface protein 2 (TROP2) protein expression and for the assessment of other exploratory biomarkers.
* Tumor has high programmed death receptor-1 (PD-L1) expression (TPS =50%) as determined by PD-L1 immunohistochemistry (IHC) 22C3 pharmDx assay by central testing (minimum of 6 slides).
* Has an adequate treatment washout period before Cycle 1 Day 1.
* Measurable disease based on local imaging assessment using RECIST Version 1.1.
* Has left ventricular ejection fraction (LVEF) =50% by either an echocardiogram (ECHO) or multigated acquisition scan (MUGA) within 28 days before randomization.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at screening.
* Has a life expectancy of at least 3 months.
* Adequate bone marrow function within 7 days before randomization.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has received prior systemic treatment for advanced or metastatic NSCLC.
* Has received prior treatment for NSCLC with any of the following, including in the adjuvant/neoadjuvant setting:

1. Any agent, including an antibody-drug conjugate, containing a chemotherapeutic agent targeting topoisomerase I.
2. TROP2-targeted therapy.
3. Any anti-programmed death receptor-1 (PD-1), anti-PD-L1, or anti-PD-ligand 2 (L2) agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137).
4. Any other immune checkpoint inhibitors. Participants who received adjuvant or neoadjuvant therapy OTHER than those listed above, are eligible if the adjuvant/neoadjuvant therapy was completed at least 6 months prior to the diagnosis of advanced/metastatic disease.
* Has spinal cord compression or active and untreated central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases and who are asymptomatic may participate provided they are radiologically stable.
* Has received prior radiotherapy < 4 weeks of start of study intervention or more than 30 Gy (unit of ionizing radiation dose in the International System of Units) to the lung within 6 months of Cycle 1 Day 1.
* History of another primary malignancy (beyond NSCLC) except for:

1. Malignancy treated with curative intent and with no known active disease =3 years before the first dose of study treatment and of low potential risk for recurrence.
2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
3. Adequately treated carcinoma in situ without evidence of disease.
4. Participants with a history of prostate cancer (tumor/node/metastasis stage) of Stage =T2cN0M0 without biochemical recurrence or progression and who in the opinion of the Investigator are not deemed to require active intervention.
* Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis including radiation 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, as judged by the investigator, resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder, or any autoimmune, connective tissue or inflammatory disorders with pulmonary involvement or prior complete pneumonectomy.
* Uncontrolled or significant cardiovascular disease, including:

1. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) interval >470 ms regardless of sex (based on the average of the 12-lead electrocardiogram determination at screening).
2. Myocardial infarction within 6 months prior to randomization.
3. Uncontrolled angina pectoris within 6 months prior to randomization.
4. LVEF <50% by ECHO or MUGA scan within 28 days before randomization.
5. New York Heart Association Class 2 to 4 congestive heart failure (CHF) at screening.
6. Uncontrolled hypertension (resting systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg) within 28 days before randomization.

Participants with a history of Class 2 to 4 CHF prior to screening, must have returned to Class 1 CHF and have LVEF =50% (by either an ECHO or MUGA scan within 28 days before randomization) in order to be eligible.

* Clinically significant corneal disease.
* Has received a live vaccine or live-attenuated vaccine (messenger ribonucleic acid and replication-incompetent adenoviral vaccines are not considered attenuated live vaccines) within 30 days prior to the first dose of study drug. For any participant receiving an approved severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) vaccine, please follow the vaccine label and/or local guidance.
* Active, known, or suspected autoimmune disease (has an active autoimmune disease that has required systemic treatment in the past 2 years).
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosage >10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy =7 days prior to the first dose of study drug.
* Has known human immunodeficiency virus (HIV) infection that is not well controlled.
* Has an active hepatitis or uncontrolled hepatitis B or active hepatitis C infection.
* Has an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
* Had an allogeneic tissue/solid organ transplant.
* Has a history of severe hypersensitivity reactions to either the drug or inactive ingredients (including but not limited to polysorbate 80) of Dato-DXd or pembrolizumab.

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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/04/2028
Actual
Sample size
Target
740
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [2] 0 0
Peninsula and South Eastern Haematology and Oncology Group - Mount Waverley
Recruitment hospital [3] 0 0
Chris Obrien Lifehouse - Camperdown
Recruitment hospital [4] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment postcode(s) [1] 0 0
3084 - Heidelberg
Recruitment postcode(s) [2] 0 0
3149 - Mount Waverley
Recruitment postcode(s) [3] 0 0
2050 - Camperdown
Recruitment postcode(s) [4] 0 0
5011 - Woodville South
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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Leiden
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Poland
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Iodzkie
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Craiova
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Zaragoza
Country [157] 0 0
Switzerland
State/province [157] 0 0
Baden
Country [158] 0 0
Switzerland
State/province [158] 0 0
Basel
Country [159] 0 0
Switzerland
State/province [159] 0 0
Liestal
Country [160] 0 0
Switzerland
State/province [160] 0 0
St.Gallen
Country [161] 0 0
Taiwan
State/province [161] 0 0
Kaohsiung City
Country [162] 0 0
Taiwan
State/province [162] 0 0
Kaohsiung
Country [163] 0 0
Taiwan
State/province [163] 0 0
Taichung
Country [164] 0 0
Taiwan
State/province [164] 0 0
Tainan
Country [165] 0 0
Taiwan
State/province [165] 0 0
Taipei City
Country [166] 0 0
Taiwan
State/province [166] 0 0
Taipei
Country [167] 0 0
Taiwan
State/province [167] 0 0
Taoyuan
Country [168] 0 0
Thailand
State/province [168] 0 0
Khon Kaen
Country [169] 0 0
Thailand
State/province [169] 0 0
Songkhla
Country [170] 0 0
Thailand
State/province [170] 0 0
Bangkok
Country [171] 0 0
Turkey
State/province [171] 0 0
Adana
Country [172] 0 0
Turkey
State/province [172] 0 0
Bornova-Izmir
Country [173] 0 0
Turkey
State/province [173] 0 0
Istanbul
Country [174] 0 0
Turkey
State/province [174] 0 0
Seyhan /Adana
Country [175] 0 0
United Kingdom
State/province [175] 0 0
Birmingham
Country [176] 0 0
United Kingdom
State/province [176] 0 0
Glasgow
Country [177] 0 0
United Kingdom
State/province [177] 0 0
Nottingham

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
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Merck Sharp & Dohme LLC
Address [2] 0 0
Country [2] 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
(US Sites) Daiichi Sankyo Contact for Clinical Trial Information
Address 0 0
Country 0 0
Phone 0 0
908-992-6400
Fax 0 0
Email 0 0
CTRinfo@dsi.com
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/NCT05215340