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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05555732




Registration number
NCT05555732
Ethics application status
Date submitted
22/09/2022
Date registered
27/09/2022

Titles & IDs
Public title
Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in 1L Non-Small Cell Lung Cancer (TROPION-Lung07)
Scientific title
A Randomized Phase 3 Study of Datopotamab Deruxtecan (Dato-DXd) and Pembrolizumab With or Without Platinum Chemotherapy in Subjects With No Prior Therapy for Advanced or Metastatic PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer Without Actionable Genomic Alterations (TROPION-Lung07)
Secondary ID [1] 0 0
2022-500802-16-00
Secondary ID [2] 0 0
DS1062-A-U303
Universal Trial Number (UTN)
Trial acronym
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
Treatment: Drugs - Pemetrexed
Treatment: Drugs - Carboplatin
Treatment: Drugs - Cisplatin

Experimental: Dato-DXd + Pembrolizumab + Platinum Chemotherapy - Participants will be randomized to receive 6.0mg/kg Dato-DXd plus 200 mg pembrolizumab plus platinum chemotherapy (cisplatin 75 mg/m\^2 or carboplatin area under the curve \[AUC) 5\]).

Experimental: Dato-DXd + Pembrolizumab - Participants will be randomized to receive 6.0mg/kg Dato-DXd plus 200 mg pembrolizumab.

Active comparator: Pembrolizumab + Pemetrexed + Platinum Chemotherapy - Participants will be randomized to receive 200 mg pembrolizumab plus 500 mg/m\^2 pemetrexed plus platinum chemotherapy (cisplatin 75 mg/m\^2 or carboplatin area under the curve \[AUC) 5\]).


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.

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

Treatment: Drugs: Carboplatin
Carboplatin will be administered an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.

Treatment: Drugs: Cisplatin
Cisplatin will be administered an intravenous (IV) infusion every 3 weeks on Day 1 of each 21-day cycle for up to 4 cycles.
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 Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
Timepoint [1] 0 0
From randomization until disease progression or death (whichever occurs first), up to approximately 29 months
Primary outcome [2] 0 0
Overall Survival in Participants in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
Timepoint [2] 0 0
From randomization until disease progression or death (whichever occurs first), up to approximately 57 months
Secondary outcome [1] 0 0
Objective Response Rate by Blinded Independent Central Review in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
Timepoint [1] 0 0
From randomization until disease progression or death (whichever occurs first), up to approximately 29 months
Secondary outcome [2] 0 0
Progression-free Survival by Investigator in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
Timepoint [2] 0 0
From randomization until disease progression or death (whichever occurs first), up to approximately 29 months
Secondary outcome [3] 0 0
Objective Response Rate by Investigator in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
Timepoint [3] 0 0
From randomization until disease progression or death (whichever occurs first), up to approximately 29 months
Secondary outcome [4] 0 0
Duration of Response by BICR and Investigator in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
Timepoint [4] 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 29 months
Secondary outcome [5] 0 0
Time to Response by BICR and Investigator in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
Timepoint [5] 0 0
From randomization to date of first objective response (CR or PR), up to approximately 29 months
Secondary outcome [6] 0 0
Disease Control Rate by BICR and Investigator in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
Timepoint [6] 0 0
From randomization until disease progression or death (whichever occurs first), up to approximately 29 months
Secondary outcome [7] 0 0
Progression-free Survival 2 in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
Timepoint [7] 0 0
From randomization until disease progression or death (whichever occurs first), up to approximately 57 months
Secondary outcome [8] 0 0
Time to Deterioration in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
Timepoint [8] 0 0
From randomization until disease progression or death (whichever occurs first), up to approximately 57 months
Secondary outcome [9] 0 0
Number of Participants With Treatment-emergent Adverse Events (TEAE) in Participants With Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
Timepoint [9] 0 0
Up to 57 months
Secondary outcome [10] 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 [10] 0 0
Baseline and up to 57 months

Eligibility
Key inclusion criteria
* Sign and date the Main Informed Consent Form (ICF), prior to the start of any study- specific qualification procedures.
* Adults =18 at the time the Main ICF is signed.
* Has tumor with PD-L1 TPS <50% as determined by PD-L1 IHC 22C3 pharmDx assay by central testing.
* Has provided a formalin-fixed tumor tissue sample for the measurement of TROP2 protein expression and for the assessment of other exploratory biomarkers.
* Has not been treated with systemic anticancer therapy for advanced or metastatic non-squamous NSCLC.
* Has measurable disease based on local imaging assessment using RECIST v1.1.
* Histologically documented NSCLC that meets all of the following criteria:

* 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).
* Documented negative test results for epidermal growth factor receptor (EGFR), lymphoma kinase (ALK), and proto-oncogene1 (ROS1) actionable genomic alterations based on analysis of tumor tissue.
* No known actionable genomic alterations 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.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1 at screening.
* Has an adequate treatment washout period before Cycle 1 Day 1.
* Is willing and able to participate in the collection of patient-reported outcomes (PRO) data.
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/metastatic NSCLC.
* Has received prior treatment with any of the following, including in the adjuvant/neoadjuvant (for NSCLC) setting:

* Any agent, including an antibody-drug conjugate, containing a chemotherapeutic agent targeting topoisomerase I.
* TROP2-targeted therapy.
* 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).
* Any other immune checkpoint inhibitors.
* Has received a live vaccine or live-attenuated vaccine 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.
* Has spinal cord compression or clinically active untreated central nervous system (CNS) metastases and/or carcinomatous meningitis.
* Uncontrolled or significant cardiovascular disease, including:

* Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) interval >470 msec regardless of sex.
* Myocardial infarction within 6 months prior to randomization.
* Uncontrolled angina pectoris within 6 months prior to randomization.
* LVEF <50% by ECHO or MUGA scan within 28 days before randomization.
* New York Heart Association Class 2 to 4 congestive heart failure (CHF) at screening.
* Uncontrolled hypertension within 28 days before randomization.
* Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses.
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.
* History of another primary malignancy (beyond NSCLC) except for:

* 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.
* Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
* Adequately treated carcinoma in situ without evidence of disease.
* Participants with a history of prostate cancer (tumor/node/metastasis stage) of Stage =T2cN0M0 without biochemical recurrence or progression.
* Has a history of severe hypersensitivity reactions to either the drugs or inactive ingredients of Dato-DXd, pembrolizumab, carboplatin, cisplatin or pemetrexed.
* Has a history of severe hypersensitivity reactions to other monoclonal antibodies.
* Has known human immunodeficiency virus (HIV) infection that is not well controlled.
* Has active or uncontrolled hepatitis B or C infection.
* Female who is pregnant or breastfeeding or intends to become pregnant.
* Any other medical conditions, including cardiac disease or psychological disorders, and/or substance abuse.
* 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.
* Has active, known, or suspected autoimmune disease.
* Has clinically significant corneal disease.
* Has had an allogeneic tissue/solid organ transplantation.
* Has received prior radiotherapy =4 weeks of start of study intervention or more than 30 Gy to the lung within 6 months of Cycle 1 Day 1.

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
11/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2027
Actual
Sample size
Target
975
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
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CRSA/ St Andrews Hospital - Adelaide
Recruitment hospital [2] 0 0
Flinders Medical Centre (Fmc) - Bedford Park
Recruitment hospital [3] 0 0
PSEHOG (Peninsula and South Eastern Haematology and Oncology Group) - Frankston
Recruitment hospital [4] 0 0
Southern Medical Day Care Centre - Wollongong
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
QLD 4102 - Woolloongabba
Recruitment outside Australia
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Turkey
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Adana
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Seyhan

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
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Commercial sector/industry
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Merck Sharp & Dohme LLC
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Ethics approval
Ethics application status

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

Contacts
Principal investigator
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Global Clinical Leader
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Daiichi Sankyo
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Fax 0 0
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Contact person for public queries
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(US Sites) Daiichi Sankyo Contact for Clinical Trial Information
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908-992-6400
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[email protected]
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/NCT05555732